A Double-Blind, Randomized Study of the Safety and Efficacy of OnabotulinumtoxinA (OnaBoNT-A) Versus Oral Oxybutynin in Spinal Cord Injured Patients With Neurogenic Detrusor Overactivity (Protocol Number 11-09-10-04)

Overactive bladder is a condition associated with symptoms of feeling the urge to urinate, urinating often, and may or may not be accompanied by leakage of urine. A patient who has a spinal cord injury (SCI) often suffers from an overactive bladder which often leads to urinary incontinence (UI - an unwanted leakage of urine).
OnaBoNT-A bladder injections have been studied in clinical research trials. The results have shown an improvement in urinary symptoms by reducing how often urine leakage occurs and by increasing the amount of urine the bladder can hold.
This purpose of this clinical trial is to see if onaBoNT-A is safe and effective when injected into the bladder for the treatment of UI and if it works better than a drug that is taken by mouth. A second purpose of the study is to perform research tests on the urine samples provided by the volunteers. Urine presents a rich source of information for bladder diseases and the biomarkers (the chemical make-up of the urine cells) will be examined to learn if there are yet undiscovered reasons for urinary diseases. These tests would be very beneficial because the results would lead to better treatment of the urinary diseases.
Volunteers will be randomized to either: ARM 1: onaBoNT-A 200 U bladder injection and placebo oral capsule daily or ARM 2: Placebo bladder injection (saline) and oxybutynin ER 10mg capsule twice a day.
The treatments are onaBoNT-A bladder injection and a placebo oral capsule once a day or placebo bladder injection and oxybutynin ER (like Ditropan) capsule twice a day. Placebo contains no active medicine. Participation in this study will be about 6-7 months and involve 5 visits to the clinic. The risks of bladder onaBoNT-A

Start Date01 Aug 2013

Sponsor / Collaborator

Baylor College of Medicine

NCT01589263

/ CompletedPhase 2IIT

Effectiveness of OnabotulinumtoxinA (onaBoNT-A) vs Oral Tamsulosin in Men With Benign Prostatic Hyperplasia & Lower Urinary Track Symptoms (#02-10-10-05)

Benign prostatic hyperplasia (BPH) and its related symptoms are a common condition that affects nearly half of men over age 50 and 90% of men over 80. Lower urinary tract symptoms (LUTS) caused by BPH can be very troublesome, affect an individual's quality of life significantly, and are costly.
his Phase 2 clinical research trial is a double-blind, randomized, placebo-controlled, parallel-group study to compare the treatment effects of onaBoNT-A 200 U versus 0.4 mg per day of oral tamsulosin in male Veterans diagnosed with moderate to severe LUTS [American Urologic Association Symptom Score (AUASS) equal to or greater than 8] associated with BPH. A total of 74 volunteers will be recruited to participate in this clinical trial. Volunteers will include only males who are greater than 50 years of age and diagnosed with LUTS associated with BPH. They are Veterans who visit the Michael E. DeBakey Veterans Affairs Medical Center - Houston (MEDVAMC). There are no eligibility restrictions as to race or ethnicity.

Start Date01 Jun 2012

Sponsor / Collaborator

VA Office of Research and Development

100 Clinical Results associated with OnabotulinumtoxinA (VA Office of Research and Development)

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100 Patents (Medical) associated with OnabotulinumtoxinA (VA Office of Research and Development)

1,404

Literatures (Medical) associated with OnabotulinumtoxinA (VA Office of Research and Development)

03 Apr 2025·Pain Management

Efficacy and safety of mAbs anti-CGRP/CGRP R (eptinezumab and erenumab) or atogepant in combination with onabotulinumtoxinA in refractory chronic migraine: a clinical trial protocol

Article

Author: Lawrence, Gary W. ; Corasaniti, Maria T. ; Iannacchero, Rosario ; Trimboli, Michele ; Bagetta, Giacinto ; Nicotera, Pierluigi ; Scuteri, Damiana

Chronic migraine is a disabling neurovascular disorder that represents the leading cause of years lived with disability in people under 50 with a remarkable social burden due to widespread resistance to the front-line treatments used routinely in current clinical practice. The present study investigates the efficacy and safety of combination therapy using eptinezumab and erenumab, recently approved monoclonal antibodies (mAbs) directed against calcitonin gene-related peptide or its receptor, respectively, or the receptor competitive antagonist atogepant together with botulinum toxin type A in chronic migraine that has proven resistant to front-line treatments for at least 6 weeks. To this aim a retrospective and a prospective phase are designed. Furthermore, a feasible salivary biomarker of migraine is under investigation in the prospective stage of the study. Based on recent expert opinions supporting the switch to easy-to-use small molecule calcitonin gene-related peptide (CGRP)-targeting, i.e. rimegepant or atogepant in unresponsive patients, the present study may offer to clinicians a novel treatment to enhance the therapeutic preventive machinery in chronic migraine.

01 Apr 2025·BJU International

Alkalinised lidocaine as an anaesthetic before onabotulinumtoxinA injections. a randomised trial

Article

Author: Klarskov, Niels ; El Issaoui, Meryam ; Elmelund, Marlene

ObjectivesTo evaluate the effect of intravesical alkalinised lidocaine as an anaesthetic treatment on procedural pain during intradetrusor onabotulinumtoxinA (BTX‐A) injections for overactive bladder.Patients and MethodsThis single‐centre, randomised, double‐blind, placebo‐controlled two period crossover trial was conducted on women scheduled for BTX‐A injections at our outpatient urogynaecology clinic between September 2022 and May 2024. Patients were randomly assigned (1:1) to receive either alkalinised lidocaine or placebo during the first treatment period. Alkalinised lidocaine solution comprised lidocaine hydrochloride (20 mg/mL, 20 mL), sodium hydrogen carbonate (1 mmoL/mL, 10 mL), and sodium chloride (9 g/L, 10 mL). The matching placebo was sodium chloride (9 g/L, 40 mL). The primary outcome measure was procedural pain rated on a 100‐mm visual analogue scale (VAS). Secondary outcomes included adverse effects such as post‐void residual urine volumes requiring catheterisation, urinary tract infection, haematuria 1 week after treatment, and patient satisfaction measured on a 5‐point scale. During the second treatment period, patients received the alternative intervention.ResultsWe enrolled 50 patients, of which 41 were eligible for per‐protocol analyses. The mean VAS score was significantly lower following intravesical alkalinised lidocaine (mean 21.3 mm, 95% confidence interval [CI] 14.7–27.8 mm) compared to placebo (mean 41.6 mm, 95% CI 35.0–48.1 mm) with a mean difference of −20.3 mm (95% CI −29.2 to −11.5 mm; P < 0.001). Adverse events and patient satisfaction did not significantly differ between the alkalinised lidocaine and placebo treatments (P = 0.825 and P = 0.138, respectively).ConclusionsIntravesical instillation of alkalinised lidocaine before BTX‐A injections significantly reduced VAS pain scores compared to placebo (ClinicalTrials.gov identifier: NCT05415865).

01 Apr 2025·Cephalalgia

Effectiveness and tolerability of atogepant in the prevention of migraine: A real life, prospective, multicentric study (the STAR study)

Article

Author: Lo Castro, Flavia ; De Cesaris, Francesco ; Pistoia, Francesca ; Marcosano, Marilena ; Ferrandi, Delfina ; Fofi, Luisa ; Montisano, Danilo Antonio ; De Santis, Federico ; Sacco, Simona ; Vaghi, Gloria ; Munafò, Antonio ; Ornello, Raffaele ; Guerzoni, Simona ; Battistini, Stefania ; Grazzi, Licia ; Doretti, Alberto ; Vernieri, Fabrizio ; Altamura, Claudia ; Corrado, Michele ; Iannone, Luigi Francesco ; Sebastianelli, Gabriele

BackgroundFocusing on calcitonin gene-related peptide (CGRP) as a specific target has changed and improved migraine management. After the positive results of monoclonal antibodies directed to the CGRP pathway (anti-CGRP mAbs), randomized controlled trials also demonstrated the efficacy of gepants in migraine prevention. The present study aimed to assess the effectiveness of atogepant in preventing migraine after a 12-week treatment in clinical practice.MethodsAdult patients with a clinical indication for atogepant 60 mg daily were screened for participation in this multicentric prospective observational cohort study. At baseline (T0) and after 12 weeks (T3) since the first atogepant administration, monthly migraine days (MMDs), monthly headache days (MHDs) and monthly acute medications (MAMs) were assessed. The co-primary endpoints were the changes in MMDs from T0 to T3 and the percentage of T3 Responders (those with a reduction of MMDs ≥50%, i.e. 50% response rate (RR)). At T0 and T3, we also collected the Headache Impact Test (HIT-6), the Migraine Disability Assessment (MIDAS) questionnaire, the Migraine Treatment Optimization Questionnaire-6 (mTOQ-6), the Migraine-Specific Quality-of-Life Questionnaire (MSQ), the 12-item Allodynia Symptom Checklist (ASC-12) and the Migraine Interictal Burden Scale (MIBS-4).Results One hundred and six patients (56/106 (52.8%) with chronic migraine (CM), 93/106 (87.7%) female, aged 50.6 ± 13.2 years) from 10 Italian centers completed the 12-week observation since the first atogepant tablet intake. From baseline to T3, a reduction of 6.9 MMDs (SD 9.7; p < 0.001) was achieved in the whole group and, specifically, of −4.9 (SD 6.6; p < 0.001) in episodic migraine (EM) and of −8.6 (SD 11.7; p < 0.001) in CM patients. Overall, 60/106 (56.6%) of patients were Responders (60.0% in the EM and 46.4% in the CM group). Non-Responders previously experienced more ineffective treatments than Responders with anti-CGRP mAbs (65.2% vs. 43.3%, respectively, p = 0.031) and with onabotulinumtoxinA (56.5% vs. 28.3%, p = 0.005), and presented more medication overuse at baseline (55.7% vs. 44.3%, p = 0.003). However, no baseline characteristics were significantly associated with the Responder status in the multiple regression analysis. For T0 to T3, MAMs, MIDAS, ASC-12 and mTOQ-6 reduced ( p ≤ 0.001 consistently), and MSQ role-function restriction increased ( p = 0.026), whereas HIT-6 and MIBS-4 did not change. Only seven subjects (7/106, 6.6%) dropped out of atogepant treatment: four for lack of effectiveness and three for adverse events or poor tolerability. ConclusionsThe STAR study demonstrates the effectiveness and tolerability of atogepant 60 mg at 12 weeks in a real-world setting. Previous ineffective anti-CGRP mAbs were not a relevant prognostic factor.Trial RegistrationThe study was preregistered on clinicaltrial.gov, NCT06414044.

News (Medical) associated with OnabotulinumtoxinA (VA Office of Research and Development)

13 Aug 2024

·www.pharmaceutical-technology.com

China NMPA accepts Junshi Biosciences’ sNDA for melanoma

The sNDA is based on the results of the MELATORCH study in patients with unresectable or metastatic melanoma. Credit: Gorodenkoff/Shutterstock. The China National Medical Products Administration (NMPA) has accepted for review Junshi Biosciences’ supplemental new drug application (sNDA) for toripalimab (TUOYI) to treat unresectable or metastatic melanoma. This sNDA is underpinned by the results of the MELATORCH study, a Phase III clinical trial demonstrating positive outcomes for toripalimab in comparison to dacarbazine. The multicentre, randomised, open-label, positive-controlled study assessed the efficacy and safety of toripalimab plus dacarbazine as a first-line treatment for unresectable or metastatic melanoma in systemic treatment-naïve patients. It was carried out at 11 clinical centres across China. In September 2023, the trial met its primary endpoint of progression-free survival (PFS). See Also: Bavarian Nordic wins positive CHMP opinion to amend Imvanex approval EAN 2024: anti-CGRPs more effective than onabotulinumtoxinA in chronic migraine prevention in real world Patients treated with toripalimab experienced a significant prolongation of PFS compared to those receiving dacarbazine. The safety profile of toripalimab was consistent with previous studies, with no new safety concerns identified. Toripalimab is an anti-PD-1 monoclonal antibody designed to hinder the interactions of PD-1 with its ligands PD-L1 and PD-L2, enhancing the immune system’s capability to eliminate tumour cells. Junshi Biosciences general manager and CEO Dr Jianjun ZOU stated: “In 2018, toripalimab made history as the first domestically developed anti-PD-1 monoclonal antibody approved for second-line and beyond treatment of advanced melanoma, leaving its brilliant mark in China’s pharmaceutical and biotech development. “Today, our efforts continue with the NMPA’s acceptance of the 12th sNDA for toripalimab, and toripalimab is poised to become China’s first immunotherapy for melanoma. We will work closely with regulatory authorities to provide better clinical treatments to patients as soon as possible.” In June 2024, the NMPA approved Junshi Biosciences’ toripalimab injection, combined with paclitaxel injection (albumin-bound), for the first-line treatment of recurrent or metastatic triple-negative breast cancer.

Drug ApprovalClinical ResultPhase 3ImmunotherapyBiosimilar

19 Apr 2023

·pipelinereview.com

U.S. FDA Approves QULIPTA® (atogepant) for Adults With Chronic Migraine

QULIPTA® now the first and only oral CGRP receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic Expanded indication provides an additional treatment option for those with chronic migraine whose frequent disabling attacks negatively impact performance of daily activities Approval based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment AbbVie is the only company with three prescription treatments designed to meet patient needs across the full spectrum of migraine AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved expanding the indication of QULIPTA® (atogepant) for the preventive treatment of migraine in adults. The approval makes QULIPTA the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine. People living with chronic migraine experience headaches for 15 or more days per month, with at least eight of those days associated with migraine.1 Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9120951-abbvie-qulipta-migraine/ "Since September 2021, QULIPTA has helped people living with episodic migraine prevent migraine attacks, reducing the daily burden of migraine. Now, those with the most challenging to treat chronic migraine can also rely on QULIPTA to significantly reduce their migraine days," said Roopal Thakkar, senior vice president, chief medical officer, AbbVie. "This approval makes AbbVie the only company with three treatments across the spectrum of migraine, including QULIPTA as a preventive treatment for both episodic and chronic migraine; BOTOX® (onabotulinumtoxinA), our foundational, first FDA-approved preventive treatment for chronic migraine; and UBRELVY® (ubrogepant), an acute treatment for migraine attacks." QULIPTA's expanded chronic migraine indication is based on the pivotal Phase 3 PROGRESS trial evaluating QULIPTA 60 mg once daily in adult patients with chronic migraine, which met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period.2 The average monthly migraine days (MMDs) for patients at baseline during the clinical trial was 19.3 The trial also demonstrated that treatment with QULIPTA resulted in statistically significant improvements in all six secondary endpoints.3 This includes key secondary endpoints that measured the proportion of patients that achieved at least a 50 percent reduction in mean monthly migraine days across the 12-week treatment period and improvements in function and reduction in activity impairment due to migraine.4 These efficacy results are consistent with those in the ADVANCE episodic migraine trial.5 "The FDA approval is an important milestone, providing those most impacted by migraine with a new, safe and effective treatment option in a convenient, once-daily pill," said Peter McAllister, M.D., Director of the New England Center for Neurology and Headache. "QULIPTA's data demonstrate that it helps reduce the burden of migraine by delivering improvements in function, with high response rates and sustained efficacy over 12 weeks. These are critical factors neurologists and headache specialists consider when prescribing a treatment option, particularly for those with chronic migraine." QULIPTA blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine – 10 mg, 30 mg and 60 mg. Only the 60 mg dose of QULIPTA is indicated for the preventive treatment of chronic migraine. The overall safety profile of QULIPTA is consistent with the episodic migraine patient population, with the most common adverse events including constipation, nausea and fatigue/sleepiness.6 "For years, I felt hopeless and struggled to find a treatment that not only reduced the number of migraine attacks but could also help reduce how often migraine impacted my daily activities like taking my kids to school or practices," said Latoya Lawrence, a patient who has lived with migraine for more than 20 years. "After I started taking QULIPTA for my episodic migraine, I wasn't as worried about when my next migraine attack might strike. I'm glad people living with chronic migraine now have a treatment option that has the potential to make a substantial impact on their lives." About the Phase 3 PROGRESS Clinical Trial The Phase 3 PROGRESS clinical trial evaluated the safety, tolerability and efficacy of oral QULIPTA 60mg once daily (QD) for the preventive treatment of chronic migraine.7 The patient population for the study included patients with a diagnosis of chronic migraine for at least one year, and greater than or equal to 15 headache days with greater than or equal to eight migraine days in the 28 days prior to randomization.7 The primary endpoint measured the reduction from baseline in mean monthly migraine days compared to placebo across a 12-week treatment period.7 Key secondary endpoints across the 12-week treatment period included: change from baseline in mean monthly headache days; change from baseline in mean monthly acute medication use days; proportion of participants with at least a 50% reduction in mean monthly migraine days; and change from baseline in Migraine Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function-Restrictive domain score at Week 12. The MSQ v2.1 is a questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past four weeks. Key secondary endpoints also included change from baseline in Activity Impairment in Migraine-Diary (AIM-D) Performance of Daily Activities and Physical Impairment domain scores. The AIM-D is a novel questionnaire designed to evaluate difficulty with performance of daily activities and physical impairment due to migraine. About QULIPTA® (atogepant) QULIPTA® is approved by the U.S. Food and Drug Administration (FDA) and is available in the United States for the preventive treatment of migraine in adults. QULIPTA is the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology, and studies have shown that CGRP levels are elevated during migraine attacks. QULIPTA blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine – 10 mg, 30 mg and 60 mg. Only the 60 mg dose of QULIPTA is approved for the preventive treatment of chronic migraine. About UBRELVY® (ubrogepant) UBRELVY® is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the acute treatment of migraine with or without aura in adults that is an option for a wide range of patients who experience migraine attacks. UBRELVY® is the first pill of its kind to directly block CGRP, a protein released during a migraine attack, from binding to its receptors. About Migraine and Chronic Migraine Migraine is a complex neurological disease with recurrent attacks that are often incapacitating and characterized by severe, throbbing headache pain as well as compounding associated symptoms like extreme sensitivity to light, sound or nausea.8 It is highly prevalent, affecting more than 1 billion people worldwide, including nearly 40 million people in the United States alone, and is the highest cause of disability worldwide for people under 50 years of age.9-12 People living with chronic migraine experience headaches or migraine for 15 or more days per month, with at least eight of those days associated with migraine.13 It is differentiated from episodic migraine, which is characterized by 0-14 headache days per month,14 by its more debilitating disease profile including greater prevalence of comorbid conditions as well as higher frequency of headache and migraine days.14-16 Individuals with chronic migraine experience frequent disabling migraine attacks, preventing them from performing daily activities and significantly affecting their quality of life. This results in substantial societal and familial burden.17-21 Significant direct and indirect costs are also associated with chronic migraine, leading to economic burden for patients and healthcare systems.22-24 About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. SOURCE: AbbVie

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Indication	Highest Phase	Country/Location	Organization	Date
Lower Urinary Tract Symptoms	Phase 2	United States	-	01 Jun 2012
Prostatic Hyperplasia	Phase 2	United States	-	01 Jun 2012

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01589263 (CTgov)	Phase 2	Prostatic Hyperplasia \| Lower Urinary Tract Symptoms	63	Tamsulosin + placebo+onaBoNT-A + placebo (ARM 1: onaBoNT-A + Placebo)	behslnmxsj(acguhhnqye) = ucqvqyjfku llnyjjbqad (olblrerkcn, iijtsoqzls - fdmdujlxaj) View more	-	05 Oct 2021
				Tamsulosin + placebo+onaBoNT-A + placebo (ARM 2: Saline + Tamsulosin)	behslnmxsj(acguhhnqye) = nexnctlyxv llnyjjbqad (olblrerkcn, mihgdujnsh - eyugwaamgk) View more

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