[Translation] A randomized, open-label, two-period, double-crossover bioequivalence study of eslicarbazepine acetate tablets in healthy subjects under fasting and fed conditions

研究空腹或餐后状态下，单次口服醋酸艾司利卡西平片受试制剂(规格：400mg，生产商：扬子江药业集团有限公司，提供商：扬子江药业集团北京海燕药业有限公司）与参比制剂（Aptiom®，规格：400mg，持证商：Sunovion Pharmaceuticals Inc. ）在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

To study the pharmacokinetic behavior of the test preparation of eslicarbazepine acetate tablets (specification: 400 mg, manufacturer: Yangtze River Pharmaceutical Group Co., Ltd., provider: Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd.) and the reference preparation (Aptiom®, specification: 400 mg, licensee: Sunovion Pharmaceuticals Inc.) in healthy subjects after a single oral administration in the fasting or postprandial state, and to evaluate the bioequivalence of the two preparations. To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date08 Jun 2020

Sponsor / Collaborator

Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd.

NCT04095182 / CompletedPhase 1

A Dose Randomized, Double-blind, Placebo Controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of Zebinix (Eslicarbazepine Acetate) After Oral Administration in Healthy Korean and Caucasian Adult Subjects

A dose randomized, double-blind, placebo controlled, single and multiple dosing, dose-escalation phase I clinical trial to investigate the safety, tolerability and pharmacokinetic characteristics of Zebinix (Eslicarbazepine acetate) after oral administration in healthy Korean and Caucasian adult subjects

Start Date22 Aug 2019

Sponsor / Collaborator

Whan In Pharmaceutical Co., Ltd.

EUCTR2018-002747-29-SE / Not yet recruitingPhase 2

Prevention of epilepsy in stroke patients at high risk of developing unprovoked seizures: anti-epileptogenic effects of eslicarbazepine acetate

Start Date05 Jun 2019

Sponsor / Collaborator

BIAL-Portela & Cia SA

100 Clinical Results associated with Eslicarbazepine Acetate

100 Translational Medicine associated with Eslicarbazepine Acetate

100 Patents (Medical) associated with Eslicarbazepine Acetate

576

Literatures (Medical) associated with Eslicarbazepine Acetate

01 Dec 2024·Seizure: European Journal of Epilepsy

Exploration of the potential association between newer antiseizure medications and arrhythmias: Integrating pharmacovigilance and bioinformatics evidence

Article

Author: Wu, Xuemei ; Chen, Zhenhui ; Shen, Yun ; Ye, Yanrong ; Zhou, Jianxing ; Zhang, Mengjun

INTRODUCTIONArrhythmias resulting from newer antiseizure medications (ASMs) may significantly impact the safety and quality of life of patients with epilepsy. This study investigated the potential association between new first-line or second-line ASMs and arrhythmias.METHODSPharmacovigilance analysis was conducted using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) from 2004 to 2023. A disproportionality analysis was performed to compare newer ASMs with other drugs, using carbamazepine and valproate as positive controls. Newer ASMs were categorized into sodium channel (SCN) main mechanism, SCN possible mechanism, and non-SCN group. The bioinformatics analysis involved retrieving therapeutic gene targets for ASMs from the DrugBank and OMIM databases, as well as identifying arrhythmia disease targets from the GeneCards database. Additionally, enrichment analysis of gene ontology functions and KEGG pathways was conducted.RESULTSA total of 3,457 cases of arrhythmias associated with newer ASMs were identified in the FAERS database. Disproportionality analysis indicates that brivaracetam (IC025 = 0.08), zonisamide (IC025 = 0.13), eslicarbazepine (IC025 = 0.39), and lacosamide (IC025 = 0.84) exhibited a positive signal for arrhythmias, with signals predominantly observed in the SCN main mechanism group. Furthermore, bioinformatics analysis revealed the involvement of adrenergic signaling in cardiac myocytes, as well as the participation of sodium channel genes in ASM-induced arrhythmias.CONCLUSIONOur findings suggest a potential association between SCN-ASMs and arrhythmias, highlighting the importance of monitoring and evaluating the safety profiles of newer ASMs in clinical practice. Further research is necessary to elucidate the underlying mechanisms and inform patient care strategies.

01 Nov 2024·Seizure: European Journal of Epilepsy

Antiseizure medication-induced hypersensitivity reactions: Data from a large healthcare system

Article

Author: Ali, Irfan ; Barton, Christopher Ryan ; Karakas, Cemal ; Shoup, Jaime ; Haneef, Zulfi ; Brock, Dylan ; Candan, Feride Un ; Cadle, Benjamin

BACKGROUND AND OBJECTIVESData on hypersensitivity reactions (HR) to individual anti-seizure medications (ASMs), and reactions to additional ASMs, is often limited by sample size. This data is vital in helping clinicians identify initial and subsequent ASMs to use in treating persons with epilepsy (PWE). Using a very large dataset, our study attempts to quantify the occurrence of HR across 31 different ASMs. We also attempt to investigate whether certain pairs of ASMs are associated with a higher frequency of HR.METHODSThe Slicer-Dicer tool in the Epic electronic medical records system was used to analyze patients seen between 2012 and 2022 at a large healthcare system in Kentucky with recorded exposures to 31 different ASMs. Incidence of HR with these ASMs were identified, both with single drugs or pairs of drugs, as well as incidence of HR stratified by sex and ASM structure.RESULTSA total of 573,571 patients with 967,168 exposures were analyzed. Phenobarbital had the highest rate of HR at 12.9 %. Usage of aromatic ASMs were most associated with patients having HR to other ASMs. HR to 13/31 studied ASMs was more likely to occur in females, while HR was more likely in males with lacosamide. Aromatic ASMs were more likely (p < 0.0001) to be associated with HR compared to non-aromatic ASMs. Carbamazepine and the related drugs oxcarbazepine and eslicarbazepine were associated with the greatest number of drug pairings in which the patient had HR to both medications at any time point.DISCUSSIONOur data reveals important patterns in HR to ASMs that may be valuable to clinicians treating PWE. Clinicians should monitor closely for HR when beginning a new ASM in a patient who has taken an aromatic ASM, especially carbamazepine, oxcarbazepine, or eslicarbazepine as well as phenobarbital.

01 Oct 2024·Medicina Clínica

Drug-induced hyponatraemia and possible related signals: Analysis of 659 cases reported to the Spanish Pharmacovigilance System and disproportionality analysis

Article

Author: Estévez Asensio, Lucía ; Fernández-Araque, Ana M. ; Fernández-Araque, Ana M ; Sainz-Gil, María ; Verde Rello, Zoraida ; Velasco-González, Verónica ; García, Montserrat

INTRODUCTIONHyponatraemia has negative effects on cognitive function and gait stability and is a risk factor for osteoporosis, falls, fractures and hospital mortality. Acute hyponatraemia can lead to neurological dysfunction due to cerebral oedema. Its rapid correction can also be fatal, leading to osmotic demyelination syndrome. For some antiepileptics, thiazides, benzodiazepines or antidepressants this reaction is widely described. Knowing which drugs are most likely to cause hyponatraemia will allow early detection and prevention of its complications, as well as individualising the prescription of these drugs according to the patient's characteristics.OBJECTIVEThe main objectives are to identify potential new safety signals related to hyponatraemia and to analyse the cases of hyponatraemia reported to the Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H).METHODA disproportionality and a descriptive analysis of individual case safety reports (ICSR) was performed in the SEFV-H database (FEDRA).RESULTSSix hundred and fifty-nine cases of suspected drug-induced hyponatraemia were found (0.6% of the total database). Over the 5 years period studied, there was a 57% increase in the number of hyponatraemia reports in Spain. Most of the reported cases were serious (93%). Patients were most often women (63.7%) and elderly (71.9%). The time to onset ranged from 1 to 7030 days (median, 79 days) and approximately 70% of the total occurred within the first year of treatment. Five hundred and forty-six patients (82.9%) showed complete recovery after the withdrawal of the suspected medicine. Diuretics (reported in 57.7% of the cases), antidepressants (in 25%), drugs acting on renin angiotensin system (in 24%) and antiepileptics (in 20.2%) were the most frequent involved drugs. Disproportionate reporting has been found for almost all the substances most frequently reported, higher for amiloride and oxcarbazepine. Regarding new safety signals, the Reporting Odds Ratio (ROR) (95% CI) was found to be statistically significant for valsartan [7.7 (5.1-11.5)], olmesartan [7.3 (4.7-11.1)], amlodipine [3.4 (2.1-5.4)], pregabalin [2.5 (1.4-4.5)], irbesartan [18.6 (9.6-35.9)], paliperidone [2.7 (1.3-5.7)], ritonavir [2.4 (1.1-5.5)], atosiban [29.7 (8.6-102.2)], melphalan [9.7 (3.5-26.8)] and clozapine [4.4 (1.6-11.8)]. These active ingredients do not include this reaction on their SPC and comply with the EMA criteria for a safety signals.CONCLUSIONThere are increasing reports of drug-induced hyponatraemia. It can be serious and seems to most often affect women over 65 years of age who take more than 1 medication. The time to onset varies and can be very long, so patient monitoring should be continuous throughout treatment. Hydrochlorothiazide is the drug with the highest number of reported cases in our setting. In terms of disproportionate reporting, diuretics leads the list, followed by antiepileptics as oxcarbazepine and eslicarbazepine. Safety signals were found for several drugs, more plausibly for pregabalin and paliperidone, thus a possible association between these drugs and hyponatraemia/SIAD is identified. This signal must be further studied. Meanwhile healthcare professionals should pay attention to this possibility. The reporting of suspected ADRs is essential to understand the risks associated with medicines once they are on the market.

News (Medical) associated with Eslicarbazepine Acetate

10 Jul 2023

·www.biospace.com

Sumitomo Pharma America Launches as New Combined Organization with Expanded Scale, Resources & Capabilities

CAMBRIDGE, Mass., July 10, 2023 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA), as previously announced on April 3, 2023, is pleased to share it has successfully launched its operations in the U.S. and related markets. The newly combined company is focused on addressing unmet patient needs in critical disease areas across psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. SMPA's diverse portfolio includes six marketed products and a robust pipeline of early- to late-stage assets, with topline data for two of its Phase 3 candidates in the fields of psychiatry and urology expected this quarter. The company will apply its proprietary advanced analytics and computational technology platforms to support and accelerate its diverse pipeline and commercial programs as well as needed innovations in priority areas of discovery, science, research and development. SMPA's President and Chief Executive Officer, Myrtle Potter, Chief Executive Officer of Biopharma, Adele Gulfo, and Chief Medical Officer, Armin Szegedi, were appointed as Executive Officers of Sumitomo Pharma Co., Ltd. effective July 1, 2023. Innovation Growth Engine "We are pleased to have successfully completed the combination of Sumitomo Pharma's U.S. subsidiaries to form SMPA," said Hiroshi Nomura, Representative Director, President and Chief Executive Officer of Sumitomo Pharma. "As a Sumitomo Pharma Group growth engine, SMPA will focus on maximizing the value of the three key products early, namely, ORGOVYX®, MYFEMBREE®, and GEMTESA®. SMPA will propel scientific and therapeutic innovations to meaningfully impact the evolving health needs of patients in North America and promote development to meet the needs of patients worldwide while also delivering long-term value to society as a stronger, more profitable enterprise." "SMPA comprises some of the brightest talent in drug development, business, science, and technology, operating as one global team to push beyond industry norms and reimagine what's possible," said Myrtle Potter, President and Chief Executive Officer, Sumitomo Pharma America. "Our goal is to realize new treatments with greater benefit to patients while maximizing the potential of our key marketed and development assets to better support areas of critical need and provide potential treatment options where solutions are lacking or do not exist." Commercial Biopharma Business Adele Gulfo, Chief Executive Officer of Biopharma Commercial of Sumitomo Pharma America, said, "SMPA is poised to help solve health challenges in critical disease areas through the exceptional talents and dedication of our highly experienced cross-functional team. SMPA's broad product portfolio, including key brands, ORGOVYX®, MYFEMBREE® and GEMTESA®, will drive the growth of our business and fuel future potential investments. We are deeply committed to the patients we serve in oncology, women's health, urology, rare disease, psychiatry, and neurology, as well as our additional products APTIOM®, RETHYMIC®, and LATUDA®, which healthcare providers and patients continue to rely on." R&D & Pipeline Armin Szegedi, Chief Medical Officer of Sumitomo Pharma America, said, "SMPA has a robust and balanced pipeline, with more than 30 assets and dozens of clinical trials currently underway, to address areas of significant need in psychiatry, neurology, oncology, urology, and regenerative medicine. I am excited about the opportunities we have at SMPA to develop innovative treatments across multiple therapeutic indications, including our lead pipeline candidate, ulotaront, which is being studied in individuals living with schizophrenia, generalized anxiety disorder and the adjunctive treatment of major depressive disorder." Jatin Shah, Chief Oncology Development Officer of Sumitomo Pharma America, added, "SMPA is uniquely positioned with a strong internal discovery and translational research engine committed to the identification and development of innovative, best-in-class, oncology therapies. We are also looking forward to quickly advancing our oncology programs including, TP-3654, an investigational selective oral PIM1 kinase inhibitor, being studied for patients with myelofibrosis (MF) and DSP-5336, an investigational small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein, being evaluated for the treatment of acute myeloid leukemia (AML)." SMPA's leadership team comprises industry-leading experts with deep life sciences expertise across the business and drug development spectrum, as well as quality & manufacturing, commercialization, and data & analytics. We invite you to learn about SMPA's full leadership team and capabilities on our new website: . About Sumitomo Pharma America, Inc. Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. The company's diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. SMPA leverages proprietary in-house advanced analytics and computational technology platforms to accelerate discovery, research, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma Co., Ltd., company. For more information on SMPA, visit our website or follow us on LinkedIn. About Sumitomo Pharma Co., Ltd. Sumitomo Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries with more than 6,000 employees worldwide. Sumitomo Pharma defines its Mission as "To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide." Additional information about Sumitomo Pharma is available through its corporate website at . Forward-Looking Statements This press release contains forward-looking statements that may be deemed to be "forward-looking statements" within the meaning of applicable securities laws and Sumitomo Pharma America, Inc. may make related oral, forward-looking statements on or following the date hereof. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Forward-looking statements, by their nature, are subject to a variety of inherent risks and uncertainties that could cause actual results to differ materially from the results projected and reported results should not be considered as an indication of future performance. Many of these risks and uncertainties cannot be controlled by Sumitomo Pharma America, Inc. and you should not place undue reliance on any forward-looking statements. These forward-looking statements are based on information available to Sumitomo Pharma America, Inc. as of the date of this communication and speak only as of the date of this communication. Sumitomo Pharma America, Inc. does not assume any obligation to publicly update any forward-looking statements, except as may be required by law. No information contained on any website referenced in this press release is incorporated by reference herein. Sumitomo Pharma America, Inc. is a registered trademark of Sumitomo Pharma Co., Ltd. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. © 2023 Sumitomo Pharma America, Inc. All rights reserved. SMPA IR / Media Contact: Maya Frutiger VP, Head of Corporate Communications Sumitomo Pharma America, Inc. CorpComms@us.sumitomo-pharma.com View original content to download multimedia: SOURCE Sumitomo Pharma America, Inc.

Executive ChangePhase 3

20 Feb 2009

·www.pharmatimes.com

EMEA calls for Raptiva suspension, issues latest recommendations

On a busy day for the regulator, the European Medicines Agency has recommended that marketing authorisation be suspended for Merck KGaA/Genentech's psoriasis drug Raptiva over possible links between the drug and a rare but deadly brain infection. The EMEA’s Committee for Medicinal Products for Human Use (CHMP) said the benefits of Raptiva (efalizumab) no longer outweigh its risks, because of safety concerns, notably the occurrence of progressive multifocal leukoencephalopathy (PML) in patients taking the medicine. The CHMP noted three confirmed cases of PML in patients who had taken Raptiva for more than three years, two of resulted in the patient’s death, and the agency has received an additional report of a suspected case of PML, “which could not be confirmed”. Nevertheless, following a review, the CHMP has concluded that “Raptiva’s benefits are modest”. In addition to PML, Raptiva is associated with other serious side effects, including Guillain-Barre and Miller-Fisher syndromes, encephalitis, encephalopathy, meningitis, sepsis and opportunistic infections,” the EMEA noted. It added that “there is not enough evidence to identify a group of patients in which the benefits of Raptiva outweigh its risks”. The EMEA’s call for suspension came as its counterpart in the USA, the Food and Drug Administration, issued a public health advisory about the three confirmed reports of PML and the possible fourth case. The FDA stated that it will “take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits”. Merck, which markets Raptiva in Europe, said it would work with health authorities across the continent "to undertake all necessary measures to comply with the EMEA recommendations." Earlier this week, the Darmstadt-based group noted that it had written off 195 million euros due to “sharply lower sales expectations” for the drug. Staying with the EMEA, the agency has issued the latest list of positive opinions from the CHMP. The drugs recommended for approval include Wyeth’s Conbriza (bazedoxifene) for postmenopausal osteoporosis, Bial’s anti-epileptic Zebinix (eslicarbazepine; see story on today’s elert) and Fresenius’ Removab (catumaxomab) for the removal of cancerous fluid from the abdomen. The CHMP is also recommending approval for Nycomed’s over-the-counter versions of its own heartburn drug Pantozol (pantoprazole) and Teva’s generic version of Novartis’ anti-dementia drug Exelon (rivastigmine). However, it adopted a negative opinion for Biferonex (interferon-beta-1a), from Switzerland’s BioPartners, for multiple sclerosis. BioPartners is appealing the decsion, claiming that Biferonex demonstrated safety and efficacy profiles comparable to established interferon beta-1a products already on the market".

100 Deals associated with Eslicarbazepine Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D09612	Eslicarbazepine Acetate	N03AF04	DB09119

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Epilepsy	KR	Whan In Pharmaceutical Co., Ltd.	10 Nov 2020
Epilepsies, Partial	EU	BIAL-Portela & Cia SA	21 Apr 2009
Epilepsies, Partial	LI	BIAL-Portela & Cia SA	21 Apr 2009
Epilepsies, Partial	IS	BIAL-Portela & Cia SA	21 Apr 2009
Epilepsies, Partial	NO	BIAL-Portela & Cia SA	21 Apr 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Epilepsies, Partial	Phase 1	PH	BIAL-Portela & Cia SA	07 Dec 2007
Epilepsies, Partial	Phase 1	UA	BIAL-Portela & Cia SA	07 Dec 2007
Epilepsies, Partial	Phase 1	MY	BIAL-Portela & Cia SA	07 Dec 2007
Epilepsies, Partial	Phase 1	RU	BIAL-Portela & Cia SA	07 Dec 2007
Epilepsies, Partial	Phase 1	BA	BIAL-Portela & Cia SA	07 Dec 2007
Epilepsies, Partial	Phase 1	RS	BIAL-Portela & Cia SA	07 Dec 2007
Epilepsies, Partial	Phase 1	MD	BIAL-Portela & Cia SA	07 Dec 2007
Epilepsies, Partial	Phase 1	TW	BIAL-Portela & Cia SA	07 Dec 2007
Seizures	Phase 1	PT	BIAL-Portela & Cia SA	01 Jul 2004
Epilepsy	Discovery	CZ	Sumitomo Pharma America, Inc.	01 Aug 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


HEP2 (HEP2, IEC2023)	Not Applicable	-	146	Levetiracetam	siyohaskdm(dspqcrzyvs) = jocnvrxnri hzzfedtnsq (xzlnnobkzv, 38.5%) View more	-	04 Sep 2023
				Lamotrigine	siyohaskdm(dspqcrzyvs) = dqnsqjiyka hzzfedtnsq (xzlnnobkzv, 43.5%) View more
IEC2023	Not Applicable	Behavioural disorders	849	Eslicarbazepine Acetate	ajypdsinli(nufjwfjjkw) = 43 reports vlarhayemn (gitqgksmck ) View more	-	04 Sep 2023
P4-1.010 (AAN2023)	Not Applicable	Seizures	-	Eslicarbazepine Acetate 400mg/day	vrhfiocuxb(wjmryeqzfg) = wbjetttdal fcslhtepfa (xcuvjpscfr, 8.6)	Positive	25 Apr 2023
				Eslicarbazepine Acetate 800mg/day	vrhfiocuxb(wjmryeqzfg) = tpqvsmuvsv fcslhtepfa (xcuvjpscfr, 6.2)
BIA-2093-208, BIA-2093-305 (EAN)	Phase 2/3	Seizures	-	Eslicarbazepine acetate	huzdxzlota(gjbdmxyspy) = mkkodatdvi ovkvcrfqjx (tcoxcreczw ) View more	Positive	24 Jun 2022
				Placebo	huzdxzlota(gjbdmxyspy) = kikfjmjshu ovkvcrfqjx (tcoxcreczw ) View more
BIA-2093-304 (Part I, EAN)	Not Applicable	-	496	Eslicarbazepine acetate 800mg/day	fgjmswntlv(ibgeglpned) = 7.5% in Part II and not reported in Part III tmzdhbttcl (jnbtmtcwfi ) View more	Positive	18 Jun 2021
				Eslicarbazepine acetate 400-1600mg/day
EAN	Not Applicable	Pregnancy	3,986	Eslicarbazepine acetate	dpipooiwbe(pfuwfwttfs) = wcdwknynmo smbbnqvpft (tjpedsuirr ) View more	Positive	18 Jun 2021
NCT00957047 \| NCT00957684 \| NCT00988429 (Pubmed)	Phase 3	Epilepsies, Partial \| Seizures	-	eslicarbazepine acetate (Older adults (≥60 years))	(krmtllbwrd) = vptfjwpslq sepcermaae (navdtvbezs ) View more	-	01 Jan 2021
				eslicarbazepine acetate (Younger adults (18-59 years))	(krmtllbwrd) = mdrqmkclzy sepcermaae (navdtvbezs ) View more
NCT02484001 (Pubmed) Manual	Phase 3	Epilepsies, Partial	184	eslicarbazepine acetate (ESL/ESL)	bdwpztrfrn(nzfgvedwum) = ecyxjerdly yqsuckxhmi (ougrzjorsg, 0.0292 - 0.1366) View more	Positive	01 Oct 2020
				controlled-release carbamazepine+eslicarbazepine acetate (CBZ-CR/ESL)	bdwpztrfrn(nzfgvedwum) = cpdgmfuxls yqsuckxhmi (ougrzjorsg, 0.0180 - 0.1210) View more
NCT03116828 (1585, CTgov)	Phase 4	Epilepsies, Partial	102	eslicarbazepine acetate (Eslicarbazepine Acetate (Arm 1))	cscundataw(xflgdcrdsc) = esxuuuswqf rhefcrdfdz (aqueszufvc, sjsjpzuesz - xfzxkfiteo)	-	16 Jun 2020
				eslicarbazepine acetate (Eslicarbazepine Acetate (Arm 2))	cscundataw(xflgdcrdsc) = heewwxeuam rhefcrdfdz (aqueszufvc, ywiyjwqkqx - ijrqguzlss)
Euro-Esli study (AAN2020)	Not Applicable	MERRF Syndrome	1,559	Eslicarbazepine acetate	cpkggrmzae(pxtvsyotjr) = etptmyclet idqrwlzvnk (zvcmsanadi )	Positive	14 Apr 2020

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