主要研究目的：以健康受试者为研究对象，以北京福元医药股份有限公司持有的罗替高汀贴片（规格：4.5 mg/10 cm2（释药量2 mg/24 h））为受试制剂，以UCB Pharma S.A.生产的罗替高汀贴片（商品名：Neupro®，规格：4.5 mg/10 cm2（释药量2 mg/24 h））为参比制剂，比较两种制剂在健康受试者体内的吸收速度和吸收程度，评价两种制剂的生物等效性。次要研究目的：观察受试制剂罗替高汀贴片和参比制剂罗替高汀贴片在中国健康受试者中的安全性、皮肤反应性和黏附性。

[Translation]

Primary study objective: Healthy subjects were used as the research subjects, the Rotigotine patch (specification: 4.5 mg/10 cm2 (drug release 2 mg/24 h)) owned by Beijing Fuyuan Pharmaceutical Co., Ltd. was used as the test preparation, and the Rotigotine patch (trade name: Neupro®, specification: 4.5 mg/10 cm2 (drug release 2 mg/24 h)) produced by UCB Pharma S.A. was used as the reference preparation, to compare the absorption rate and extent of the two preparations in healthy subjects, and to evaluate the bioequivalence of the two preparations. Secondary study objective: To observe the safety, skin reactivity and adhesion of the test preparation Rotigotine patch and the reference preparation Rotigotine patch in Chinese healthy subjects.

Start Date31 Oct 2024

Sponsor / Collaborator

Beijing Winsunny Pharmaceutical Co., Ltd.

CTIS2024-515840-21-00

/ Not yet recruitingPhase 1

- 987/24

Start Date30 Sep 2024

Sponsor / Collaborator

EVA Pharma for Pharmaceuticals & Medical Appliances SAE

100 Clinical Results associated with Rotigotine

100 Translational Medicine associated with Rotigotine

100 Patents (Medical) associated with Rotigotine

842

Literatures (Medical) associated with Rotigotine

01 Feb 2025·INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS

Skin adhesion of a newly developed, bioequivalent rotigotine patch formulation in comparison to the originator product: Results of a multi-center, randomized, crossover trial in patients with Parkinson’s disease

Article

Author: Dax, Annika ; Wauer, Gabriel ; Schurad, Bjoern ; Warnke, André ; Leblanc, Ana ; Jost, Wolfgang H. ; Schug, Barbara ; Wang, Maggie ; Jost, Wolfgang H ; Wedemeyer, Ralph-Steven

OBJECTIVES:

To demonstrate adequate skin adhesion of a new once-daily rotigotine transdermal patch (ROT-TDS) compared to the originator product (reference) in patients with Parkinson's disease (PD).

MATERIALS AND METHODS:

Pharmacokinetic bioequivalence (PK BE) was assessed with the 4 mg/24h patches in healthy adults in a single-/multiple-dose, crossover trial. The trial investigating skin adhesion in PD patients (stable dose ≥ 8 mg/day rotigotine) was performed with the 8 mg/24h patches as a multiple-dose, crossover trial (4 alternating once-daily patch applications). Skin status (seborrhea, sweating) was characterized at screening. Adhesion was assessed 5 minutes after application and 5 minutes before removal of each patch. Systemic safety and skin irritation/sensitization were monitored.

RESULTS:

ROT-TDS was bioequivalent to the reference product in the PK BE trial in 48 randomized healthy subjects. In the skin adhesion trial in 43 randomized PD patients, the cumulative mean percentage of adhesion (90% CI) at the end-of-dosing interval was 92.948% (90.156 - 95.740%) for ROT-TDS and 90.471% (87.574 - 93.367%) for the reference. For ROT-TDS, 80.23% of patches were ≥ 90% adhered at the end-of-dosing interval, while this was the case for 67.44% of the reference patches. Safety and skin tolerability of both products were comparable; the most frequent treatment-related adverse event was application-site pruritus for both treatments at comparable extent.

CONCLUSION:

ROT-TDS - with shown BE to the originator reference product - displayed similar safety and local tolerability as the reference product in patients with PD. The results show a trend to improved skin adhesion of the new patch compared to the reference in the target population.

01 Jan 2025·Journal of Clinical Sleep Medicine

Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline

Review

Author: Scharf, Matthew T. ; Falck-Ytter, Yngve ; Koo, Brian B. ; DelRosso, Lourdes M. ; Shelgikar, Anita V. ; Trotti, Lynn Marie ; Winkelman, John W. ; Kazmi, Uzma ; Berkowski, J. Andrew ; Zak, Rochelle S. ; Sharon, Denise ; Walters, Arthur S.

INTRODUCTION:

This guideline establishes clinical practice recommendations for treatment of restless legs syndrome (RLS) and periodic limb movement disorder (PLMD) in adults and pediatric patients.

METHODS:

The American Academy of Sleep Medicine (AASM) commissioned a task force of experts in sleep medicine to develop recommendations and assign strengths based on a systematic review of the literature and an assessment of the evidence using the grading of recommendations assessment, development, and evaluation methodology. The task force provided a summary of the relevant literature and the certainty of evidence, the balance of benefits and harms, patient values and preferences, and resource use considerations that support the recommendations. The AASM Board of Directors approved the final recommendations.

GOOD PRACTICE STATEMENT:

The following good practice statement is based on expert consensus, and its implementation is necessary for the appropriate and effective management of patients with RLS.1. In all patients with clinically significant RLS, clinicians should regularly test serum iron studies including ferritin and transferrin saturation (calculated from iron and total iron binding capacity). Testing should ideally be administered in the morning avoiding all iron-containing supplements and foods at least 24 hours prior to blood draw. Analysis of iron studies greatly influences the decision to use oral or intravenous (IV) iron treatment. Consensus guidelines, which have not been empirically tested, suggest that supplementation of iron in adults with RLS should be instituted with oral or IV iron if serum ferritin ≤ 75 ng/mL or transferrin saturation < 20%, and only with IV iron if serum ferritin is between 75 and 100 ng/mL. In children, supplementation of iron should be instituted for serum ferritin < 50 ng/mL with oral or IV formulations. These iron supplementation guidelines are different than for the general population.2. The first step in the management of RLS should be addressing exacerbating factors, such as alcohol, caffeine, antihistaminergic, serotonergic, antidopaminergic medications, and untreated obstructive sleep apnea.3. RLS is common in pregnancy; prescribers should consider the pregnancy-specific safety profile of each treatment being considered.

RECOMMENDATIONS:

The following recommendations are intended as a guide for clinicians in choosing a specific treatment for RLS and PLMD in adults and children. Each recommendation statement is assigned a strength ("strong" or "conditional"). A "strong" recommendation (ie, "We recommend…") is one that clinicians should follow under most circumstances. The recommendations listed below are ranked in the order of strength of recommendations and grouped by class of treatments within each PICO (Patient, Intervention, Comparator, Outcome) question. Some recommendations include remarks that provide additional context to guide clinicians with implementation of this recommendation.

ADULTS WITH RLS:

1. In adults with RLS, the AASM recommends the use of gabapentin enacarbil over no gabapentin enacarbil (strong recommendation, moderate certainty of evidence).2. In adults with RLS, the AASM recommends the use of gabapentin over no gabapentin (strong recommendation, moderate certainty of evidence).3. In adults with RLS, the AASM recommends the use of pregabalin over no pregabalin (strong recommendation, moderate certainty of evidence).4. In adults with RLS, the AASM recommends the use of IV ferric carboxymaltose over no IV ferric carboxymaltose in patients with appropriate iron status (see good practice statement for iron parameters) (strong recommendation, moderate certainty of evidence).5. In adults with RLS, the AASM suggests the use of IV low molecular weight iron dextran over no IV low molecular weight iron dextran in patients with appropriate iron status (see good practice statement for iron parameters) (conditional recommendation, very low certainty of evidence).6. In adults with RLS, the AASM suggests the use of IV ferumoxytol over no IV ferumoxytol in patients with appropriate iron status (see good practice statement for iron parameters) (conditional recommendation, very low certainty of evidence).7. In adults with RLS, the AASM suggests the use of ferrous sulfate over no ferrous sulfate in patients with appropriate iron status (see good practice statement for iron parameters) (conditional recommendation, moderate certainty of evidence).8. In adults with RLS, the AASM suggests the use of dipyridamole over no dipyridamole (conditional recommendation, low certainty of evidence).9. In adults with RLS, the AASM suggests the use of extended-release oxycodone and other opioids over no opioids (conditional recommendation, moderate certainty of evidence).10. In adults with RLS, the AASM suggests the use of bilateral high-frequency peroneal nerve stimulation over no peroneal nerve stimulation (conditional recommendation, moderate certainty of evidence).11. In adults with RLS, the AASM suggests against the standard use of levodopa (conditional recommendation, very low certainty of evidence).Remarks: levodopa may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).12. In adults with RLS, the AASM suggests against the standard use of pramipexole (conditional recommendation, moderate certainty of evidence).Remarks: pramipexole may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).13. In adults with RLS, the AASM suggests against the standard use of transdermal rotigotine (conditional recommendation, low certainty of evidence).Remarks: transdermal rotigotine may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).14. In adults with RLS, the AASM suggests against the standard use of ropinirole (conditional recommendation, moderate certainty of evidence).Remarks: ropinirole may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).15. In adults with RLS, the AASM suggests against the use of bupropion for the treatment of RLS (conditional recommendation, moderate certainty of evidence).16. In adults with RLS, the AASM suggests against the use of carbamazepine (conditional recommendation, low certainty of evidence).17. In adults with RLS, the AASM suggests against the use of clonazepam (conditional recommendation, very low certainty of evidence).18. In adults with RLS, the AASM suggests against the use of valerian (conditional recommendation, very low certainty of evidence).19. In adults with RLS, the AASM suggests against the use of valproic acid (conditional recommendation, low certainty of evidence).20. In adults with RLS, the AASM recommends against the use of cabergoline (strong recommendation, moderate certainty of evidence).

SPECIAL ADULT POPULATIONS WITH RLS:

21. In adults with RLS and end-stage renal disease (ESRD), the AASM suggests the use of gabapentin over no gabapentin (conditional recommendation, very low certainty of evidence).22. In adults with RLS and ESRD, the AASM suggests the use of IV iron sucrose over no IV iron sucrose in patients with ferritin < 200 ng/mL and transferrin saturation < 20% (conditional recommendation, moderate certainty of evidence).23. In adults with RLS and ESRD, the AASM suggests the use of vitamin C over no vitamin C (conditional recommendation, low certainty of evidence).24. In adults with RLS and ESRD, the AASM suggests against the standard use of levodopa (conditional recommendation, low certainty of evidence).Remarks: levodopa may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).25. In adults with RLS and ESRD, the AASM suggests against the standard use of rotigotine (conditional recommendation, very low certainty of evidence).Remarks: rotigotine may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).

ADULTS WITH PLMD:

26. In adults with PLMD, the AASM suggests against the use of triazolam (conditional recommendation, very low certainty of evidence).27. In adults with PLMD, the AASM suggests against the use of valproic acid (conditional recommendation, very low certainty of evidence).

CHILDREN WITH RLS:

28. In children with RLS, the AASM suggests the use of ferrous sulfate over no ferrous sulfate in patients with appropriate iron status (see good practice statement for iron parameters) (conditional recommendation, very low certainty of evidence).

CITATION:

Winkelman JW, Berkowski JA, DelRosso LM, et al. Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2025;21(1):137-152.

01 Dec 2024·CONTACT DERMATITIS

Allergic contact dermatitis to sodium metabisulphite in a rotigotine transdermal therapeutic system

Article

Author: Alpalhão, Miguel ; Antunes‐Duarte, Sofia ; Sun, Lanyu ; Sousa, Diogo

Allergic contact dermatitis (ACD) caused by transdermal therapeutic systems (TTSs) resulting from the active drug, the adhesive, or an excipient, is rare.This report presents the first case of ACD induced by a rotigotine patch in a patient with Parkinson′s disease, identifying sodium metabisulfite, an excipient, as the implicated allergen.A 69-yr-old man, with no history of atopy, presented with a 3-wk history of itchy erythematous scaly well-demarcated square plaques on both arms at the application sites of a rotigotine TTS 2 mg/24 h (Neupro 2 mg/24 h; UCB Pharma, France Colombes).These reactions began 1 mo after started using the TTS for early signs of Parkinson′s disease.Suspecting ACD, Neupro was discontinued, and the patient was treated with betamethasone dipropionate cream 0.05%, with complete symptom resolutionPatch tests using allergens were conducted, and the tests were pos. for sodium metabisulfite (2 + at day (D)2 and D4) and rotigotine TTS (1 + at D2 and D4), and neg. for the rest of the allergens.A diagnosis of ACD to sodium metabisulfite in the Neupro TTS was confirmed.

News (Medical) associated with Rotigotine

02 Dec 2024

·www.pharmaceutical-technology.com

CBC acquires UCB’s neurology and allergy business in China

The new company aims to deliver quality treatments and address evolving neurology treatment needs in the country. Credit: Volha_R/Shutterstock. CBC Group, in partnership with the Mubadala Investment Company, has completed the strategic acquisition of Union Chimique Belge’s ( UCB ) mature neurology and allergy business in China for $680m. The move comes after UCB agreed to sell and license its business in August 2024. The deal encompasses UCB’s Zhuhai manufacturing site and its brands Xyzal, Keppra, Zyrtec, Vimpat and Neupro. They are set to be the cornerstone assets for CBC as it develops an integrated central nervous system (CNS) biopharma platform in China. Working alongside Mubadala, CBC plans to leverage its platform synergies, investor-operator approach and healthcare expertise, to optimise operations, foster innovation and expand its reach to benefit more patients in the region. The new entity formed from this acquisition called NeuroGen Pharma is set to offer neuro healthcare innovation services. It will be spearheaded by a management team with a solid background in the biopharma industry, which is expected to ensure a seamless transition and drive future growth. The company aims to deliver quality treatments and address the evolving neurology treatment needs in the country. The acquired portfolio reported combined net sales of €131m ($138m) in 2023. The strategic acquisition is part of a broader partnership between CBC and Mubadala, which also includes their joint investment in the $315m fundraising round for Hasten and an investment in CBC Healthcare Infrastructure Platform’s first life science real assets venture. CBC Group CEO Fu Wei stated: “There is clear potential within the regional healthcare space to better serve patients with unmet medical needs in this growing CNS therapeutics market, and we are delighted to partner with Mubadala once again. “This acquisition complements our existing healthcare ecosystem and aligns with our robust buyout strategy, which is strategically positioned to drive long-term, sustainable value in today’s healthcare investing market.”

Acquisition

30 Nov 2024

·www.prnewswire.com

CBC Group Completes Strategic Acquisition of UCB's Mature Product Portfolio in China

CBC Group and Mubadala acquire UCB's mature neurology and allergy business in China for US$680 million. New company is named NeuroGen Pharma, led by an experienced management team with a strong track record in the biopharma industry. Strategic acquisition under CBC's buyout strategy expected to drive significant value creation and positive patient outcomes through CBC's proven investor-operator approach and solution. SINGAPORE, Nov. 30, 2024 /PRNewswire/ -- CBC Group ("CBC"), Asia's largest healthcare-dedicated asset management firm headquartered in Singapore, has completed the strategic acquisition of global biopharmaceutical company UCB's mature neurology and allergy business in China, in partnership with Mubadala Investment Company, the Abu Dhabi based global investment company. The acquisition marks another successful transaction under CBC's buyout strategy of acquiring key assets from global pharmaceutical companies and a significant step in establishing a market-leading neurology company in China while expanding CBC's portfolio within the region's dynamic pharmaceutical market. The transaction, valued at US$680 million, includes UCB's well-known brands Keppra®, Vimpat®, Neupro®, Zyrtec®, Xyzal®, and the Zhuhai manufacturing site. The well-established and trusted medicine portfolio will serve as an anchor asset as CBC builds out a leading integrated central nervous system (CNS) biopharma platform in China, where the market size has reached US$33 billion1. Beyond strengthening CBC's presence in the rapidly growing Chinese healthcare market, the acquisition also enhances the firm's capabilities in meeting the rising demand for neurology and allergy treatments in the wider region. In collaboration with Mubadala, CBC will tap on its proprietary investor-operator approach, deep healthcare expertise and platform synergies to drive operational efficiencies, innovation and scale to benefit more patients across the region. Fu Wei, Chief Executive Officer of CBC Group, said, "There is clear potential within the regional healthcare space to better serve patients with unmet medical needs in this growing CNS therapeutics market, and we are delighted to partner with Mubadala once again. This acquisition complements our existing healthcare ecosystem and aligns with our robust buyout strategy, which is strategically positioned to drive long-term, sustainable value in today's healthcare investing market. Together, we are making a profound impact on the industry by harnessing our combined expertise and capital to not only enhance patient outcomes but also build value for our stakeholders. Leveraging our joint strengths, we are poised to capitalize on synergies and deploy hands-on strategic guidance to make significant strides in CNS market access and innovation." Named "NeuroGen Pharma", the new company embodies what CBC and Mubadala envision for neuro healthcare innovation. The company will be led by a deep and experienced management team with an extensive track record in the biopharma industry, ensuring a smooth transition to propel into the next phase of growth. NeuroGen Pharma is expected to deliver quality treatments to a wider reach of patients and play an important role in addressing the evolving neurology treatment needs in China. The company aims to leverage innovative therapies and cutting-edge research to enhance patient outcomes and shape the future of neurology care in the region. Combined net sales for the acquired portfolio in this transaction were Euro131 million in 2023. The strategic acquisition builds on CBC's collaboration with Mubadala, which includes their investment in CBC Healthcare Infrastructure Platform's (HIP) first life science real assets venture and the joint investment in the US$315 million fundraising round for CBC-backed Hasten, a leading pharmaceutical company. Mohamed Albadr, Head of Asia at Mubadala, said, "We are thrilled to partner with CBC Group to support the growth and development of NeuroGen Pharma as it scales to a leading entity in China and delivers transformative medicines to patients. Built on a strong foundation of proven therapies and driven by innovation and cutting-edge research, the company is uniquely positioned to address the growing need for advanced neurology and allergy treatments while aligning with our commitment to enhancing access to care and growth in the healthcare system." Jean-Christophe Tellier, CEO at UCB, said, "In the short term, UCB is exploring the launch of novel medicines in immunology, neurology, and rare diseases in China. Our dedication to serving patients with unmet needs in China remains steadfast. Building on our 28-year presence in the country, we are committed to driving patient outcomes through continued collaboration with local partners and fostering innovation. We are convinced that the CBC Group and Mubadala are the ideal partners to advance the medicine portfolio and continue to improve the lives of people living with neurology and allergy diseases in mainland China." About CBC Group Headquartered in Singapore, CBC Group is Asia's largest healthcare-dedicated asset management firm, with an AUM of US$9 billion. With a diversified, multi-product strategy, CBC Group is focused on platform-building, buyout, private credit and royalties, and real estate, across the healthcare space, including pharmaceutical, biotech, medical technology, and healthcare services. We are committed to creating lasting value by integrating global innovations and talents. Partnering with the world's top entrepreneurs and scientists, our unique "investor-operator" approach has empowered leading healthcare companies to widen access to affordable medical care, catalyse innovations, and improve efficiencies in fulfilling unmet medical needs worldwide. For more information on CBC Group, please visit . Connect with us on LinkedIn (CBC Group). About UCB UCB, Brussels, Belgium () is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news. About Mubadala Mubadala Investment Company is a sovereign investor managing a global portfolio, aimed at generating sustainable financial returns for the Government of Abu Dhabi. Mubadala's $302 billion (AED 1,111 billion) portfolio spans six continents with interests in multiple sectors and asset classes. We leverage our deep sectoral expertise and long-standing partnerships to drive sustainable growth and profit, while supporting the continued diversification and global integration of the economy of the United Arab Emirates. For more information about Mubadala Investment Company, please visit: . WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Acquisition

03 Sep 2024

·www.echemi.com

UCB sells mature Chinese business in a package, Middle East and Singapore capital jointly take over for nearly 5 billion yuan

UCB, a Belgian-based biopharmaceutical company, will sell its mature neurology and allergy business in China to Singapore-based asset management group CBC and Abu Dhabi-based investment company Mubadala for US$680 million (about 4.843 billion yuan). The transaction includes epilepsy drug brands Keppra and Vimpat, Parkinson's drug brand Neupro, allergy drug brands Zyrtec and Xyzal, and the company's Zhuhai production base. According to UCB, the net sales of these drugs in China in 2023 totaled 131 million euros. The transaction is subject to customary closing conditions and is expected to be completed in the fourth quarter of 2024. Jean-Christophe Tellier, CEO of UCB, said: "In the short term, UCB is exploring the launch of new medicines in the fields of immunology, neurology and rare diseases in China. We remain steadfast in our commitment to serving patients with unmet needs in China. With our 28 years of operating experience in China, we are committed to driving patient outcomes through continued collaboration with local partners and promoting innovation." CBC Group CEO Wei Fu said: "Over the past decade, China has seen growing demand for central nervous system (CNS) products, and by leveraging CBC's unique investor-operator model, we are excited to leverage our expertise, resources and platform synergies to meet these evolving needs and create value for our stakeholders." Mohamed Albadr, Head of Mubadala China, said: "We are pleased to partner with CBC Group to support the next phase of UCB's platform development to become a leading entity in China and deliver transformative medicines to the market. The company's commitment to clinical excellence and innovation is consistent with our commitment to improving access to healthcare services and promoting the development of healthcare systems." UCB said the transaction will enable it to focus on innovation and collaboration, ensuring that its strategic goals are aligned with the evolving needs of the Chinese market.

100 Deals associated with Rotigotine

External Link

KEGG	Wiki	ATC	Drug Bank
D05768	Rotigotine	N04BC09	DB05271

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Parkinson Disease	European Union	UCB Pharma SA	15 Feb 2006
Parkinson Disease	Iceland	UCB Pharma SA	15 Feb 2006
Parkinson Disease	Liechtenstein	UCB Pharma SA	15 Feb 2006
Parkinson Disease	Norway	UCB Pharma SA	15 Feb 2006
Restless Legs Syndrome	European Union	UCB Pharma SA	15 Feb 2006
Restless Legs Syndrome	Iceland	UCB Pharma SA	15 Feb 2006
Restless Legs Syndrome	Liechtenstein	UCB Pharma SA	15 Feb 2006
Restless Legs Syndrome	Norway	UCB Pharma SA	15 Feb 2006

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Primary Parkinson's disease	Phase 3	China	Shandong Luye Pharmaceutical Co., Ltd.	11 May 2020
Kidney Failure, Chronic	Phase 3	United States	UCB BioSciences GmbH	01 Apr 2012
Kidney Failure, Chronic	Phase 3	Austria	UCB BioSciences GmbH	01 Apr 2012
Kidney Failure, Chronic	Phase 3	Finland	UCB BioSciences GmbH	01 Apr 2012
Kidney Failure, Chronic	Phase 3	France	UCB BioSciences GmbH	01 Apr 2012
Kidney Failure, Chronic	Phase 3	Germany	UCB BioSciences GmbH	01 Apr 2012
Kidney Failure, Chronic	Phase 3	Italy	UCB BioSciences GmbH	01 Apr 2012
Gastrointestinal dysfunction	Phase 3	United States	UCB Pharma GmbH	01 Jan 2012
Restless Legs Syndrome 1	Phase 3	Germany	UCB Pharma GmbH	01 Nov 2005
Sleep Disorders, Intrinsic	Phase 3	Germany	UCB Pharma GmbH	01 Nov 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03728933 (CTgov)	Phase 3	Restless Legs Syndrome 1	23	Placebo	yzvqweotqk(eflguzakgz) = lyusdxwcjo rznsztbwrv (cjbehuzmwk, 6.8) View more	-	26 Oct 2023
NCT04571164 (NEWS) Manual	Phase 3	Parkinson Disease	294	LY03003	uhxbzpwfjy(abyekdniyf) = ，與安慰劑組相比，LY 03003組統一帕金森病評分量表(UPDRS)Ⅱ+Ⅲ評分較基綫顯著改善，兩組差異具有統計學意義（ P＜0.001 ）。 blesyfcvoy (qyjfeyvyvs ) View more	Positive	19 Jul 2022
				Placebo
NCT02365870 (ANXPD, CTgov)	Phase 4	Anxiety Disorders \| Parkinson Disease	4	rotigotine transdermal patch (Rotigotine)	hgcntkgftd(rhaivqebca) = kngehgqezw kizlibcoau (dfzjzldeae, 0) View more	-	19 Mar 2020
				placebo (Placebo)	hgcntkgftd(rhaivqebca) = xojtionmrd kizlibcoau (dfzjzldeae, 5.1) View more
MDS2018	Not Applicable	-	-	Rotigotine	uyfpdvryhi(rlkhdvclti) = upregulated rcenwsrhzl (fzvfsncsqk )	Positive	05 Oct 2018
				5-HT1A antagonist
NCT02230904 (PD0018, Pubmed \| Curr Med Res Opin) Manual	Phase 1	Parkinson Disease	57	rotigotine (Treatments A)	jerlexvbtf(rlxsjosqbp) = bbpcowzllq qpwcwgsguz (rdhkemlznb, 1.635) View more	Positive	01 Jul 2018
				rotigotine (Treatments B)	zyzurpbvfx(ovsvsgfevm) = czzxqspbcy wjvvvztivw (nuhyufkjxe )
NCT01646255 (SP1037, Pubmed \| Parkinsonism Relat Disord) Manual	Phase 3	Parkinson Disease	346	Rotigotine	sqwiyhxusf(tzlcpjxwlp): difference = -1.20 (95% CI, -1.83 to -0.57), P-Value = 0.0002 View more	Positive	01 Nov 2017
				Placebo
NCT01495793 (Pubmed \| Sleep Med)	Phase 2	Restless Legs Syndrome	24	Rotigotine transdermal system 0.5 mg/24 h	qkvrdgsast(aytnkfqxqw) = pqnxwuohwh adtfpdripq (iplofplpud ) View more	-	01 Apr 2017
				Rotigotine transdermal system 1 mg/24 h	qkvrdgsast(aytnkfqxqw) = cvtiippaox adtfpdripq (iplofplpud ) View more
NCT01976871 (SWITCH, CTgov)	Phase 4	Restless Legs Syndrome	21	Rotigotine	jeudlzuboa = idmebphipz kpburufxam (xltmrbyuuw, jvtbedfrwo - wkslghhtje) View more	-	13 Oct 2016
NCT01523301 (Pubmed \| Expert Opin Pharmacother)	Phase 4	Parkinson Disease	380	Rotigotine	ujkfndhzik(ucfdboqmrf) = mevhbetjif qmwhiuaibg (cotrjnyoiu )	-	01 Aug 2016

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