A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE LONG-TERM SAFETY AND TOLERABILITY OF BRIVARACETAM IN STUDY PARTICIPANTS WITH CHILDHOOD ABSENCE EPILEPSY OR JUVENILE ABSENCE EPILEPSY

The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy.

Start Date14 Jun 2024

Sponsor / Collaborator

UCB Biopharma SRL

CTR20241622 / RecruitingNot Applicable

布立西坦注射液与布立西坦片在中国健康受试者空腹状态下的一项单中心、随机、开放、两制剂、两序列、两周期交叉生物等效性试验

[Translation] A single-center, randomized, open-label, two-formulation, two-sequence, two-period crossover bioequivalence study of brivaracetam injection and brivaracetam tablets in Chinese healthy subjects under fasting condition

主要研究目的考察中国健康受试者空腹条件下单次静脉输注受试制剂布立西坦注射液(规格：50mg/5mL，生产厂家：江西青峰药业有限公司)及单次口服参比制剂布立西坦片(商品名：Briviact®，规格：50mg，持证商：UCB Pharma S.A.)后的药代动力学特征，评价两制剂在空腹条件下是否具有生物等效性。次要研究目的评价受试制剂布立西坦注射液(规格：50mg/5mL)及参比制剂布立西坦片(商品名：Briviact®，规格：50mg)在健康受试者中的安全性。

[Translation]

Main study objectives To investigate the pharmacokinetic characteristics of the test preparation brivaracetam injection (specification: 50mg/5mL, manufacturer: Jiangxi Qingfeng Pharmaceutical Co., Ltd.) and the reference preparation brivaracetam tablets (trade name: Briviact®, specification: 50mg, licensee: UCB Pharma S.A.) after a single intravenous infusion of the test preparation brivaracetam injection (specification: 50mg/5mL, manufacturer: Jiangxi Qingfeng Pharmaceutical Co., Ltd.) and a single oral dose of the reference preparation brivaracetam tablets (trade name: Briviact®, specification: 50mg, licensee: UCB Pharma S.A.) in Chinese healthy subjects under fasting conditions, and to evaluate whether the two preparations are bioequivalent under fasting conditions. Secondary study objectives To evaluate the safety of the test preparation brivaracetam injection (specification: 50mg/5mL) and the reference preparation brivaracetam tablets (trade name: Briviact®, specification: 50mg) in healthy subjects.

Start Date05 Jun 2024

Sponsor / Collaborator

Jiangxi Kerui Pharmaceutical Co., Ltd

NCT06312566 / RecruitingPhase 1

A Multiple-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Participants

The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV dry syrup after multiple oral doses in healthy male Japanese participants.

Start Date25 Mar 2024

Sponsor / Collaborator

UCB Biopharma SRL

100 Clinical Results associated with Brivaracetam

100 Translational Medicine associated with Brivaracetam

100 Patents (Medical) associated with Brivaracetam

422

Literatures (Medical) associated with Brivaracetam

01 Mar 2024·Epilepsy & behavior : E&B

Greater need for treatment optimization in patients with epilepsy initiating adjunctive therapy: Results of a retrospective claims analysis of antiseizure medication drug load in the United States

Article

Author: Schabert, Vernon F ; Becker, Danielle A ; Wade, Clarence T ; Weingarten, Mindl ; Labiner, David M ; Connor, Gregory S ; Stern, Sean

BACKGROUND:

This retrospective, observational study used US claims data to assess changes in antiseizure medication (ASM) drug load for a cohort of patients with epilepsy.

METHODS:

Adults (≥18 years) with a diagnosis of epilepsy (ICD-10 code G40.xxx) who started new adjunctive ASM treatment with one of 4 branded (brivaracetam, eslicarbazepine, lacosamide, perampanel) or 4 unbranded (carbamazepine, lamotrigine, levetiracetam, topiramate) ASMs between January 1, 2016 and December 31, 2020 were identified from IBM MarketScan® research databases (primary study population). Patients must have been continuously enrolled 360 days before the start of the new ASM (eligibility period). Follow-up was from the start of new ASM until Day 540 (∼18 months). The primary endpoint was concomitant ASM drug load, which included all ASMs except the new (comparator) ASM. A sensitivity analysis population included adults with epilepsy who were continuously enrolled for ≥ 180 days during at least one calendar year in the study period (2016-2020), whether or not the comparator ASM was new or existing during that period. Total ASM drug load, which included comparator ASM and concomitant ASMs, was assessed in the sensitivity analysis population.

RESULTS:

In total, 21,332 patients were included in the primary study population, of which 5767 initiated branded ASMs and 15,565 initiated unbranded ASMs. A total of 392,426 patients were included in the sensitivity analysis population during at least one calendar year 2016-2020. Concomitant ASM drug load increased in the 360 days prior to new ASM start and slightly declined thereafter. Mean concomitant ASM drug load for the primary population was 1.6 (SD 1.8) at new ASM start. Concomitant drug load was higher among those starting branded ASM comparators compared to those starting unbranded comparators. Mean total ASM drug load for patients increased over time and was approximately double for patients exposed to branded ASMs (mean range 2.1 to 2.7) compared to that of patients exposed to any unbranded ASM (mean range 1.0 to 1.3).

CONCLUSION:

Concomitant ASM drug load increased prior to addition of new ASM, with higher increases observed among patients starting branded vs unbranded ASMs, followed by slight decreases thereafter. Total drug load increased linearly among all patients. These findings underscore the need for ongoing ASM regimen evaluation and treatment optimization in patients with epilepsy.

01 Mar 2024·Epilepsy & behavior : E&B

Efficacy and safety of six new antiseizure medications for adjunctive treatment of focal epilepsy and epileptic syndrome: A systematic review and network meta-analysis

Review

Author: Li, Qifu ; Liu, Jiaqi ; Li, Zongjun ; Tong, Jingyi ; Chen, Yibin ; Lu, Na ; Ji, Tingting ; Liu, Ting

OBJECTIVE:

This study aimed to evaluate the efficacy and safety of six new antiseizure medications (ASMs) for adjunctive treatment in adult patients with focal epilepsy and adolescents with Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), or tuberous sclerosis complex (TSC).

METHODS:

A comprehensive literature search was performed using PubMed, Medline, Embase, and Cochrane library databases from inception to October 13, 2023. We included published studies for a systematic review and a network meta-analysis (NMA). The efficacy and safety were reported in terms of a 50% response rate and dropout rate along with serious adverse events (SAEs). The outcomes were ranked with the surface under the cumulative ranking curve (SUCRA).

RESULTS:

Twenty eligible trials with 5516 patients and 21 interventions, including placebo, contributed to the analysis. Included ASMs were brivaracetam (BRV), cenobamate (CBM), cannabidiol (CBD), fenfluramine (FFM), everolimus (ELM), and soticlestat (SLT). The six new ASMs were compared in four different epilepsy subtypes. In focal epilepsy treatment, BRV seemed to be safe [vs placebo, risk ratio (RR) = 0.69, 95 % confidence interval (CI): 0.25-1.91] and effective (vs placebo, RR = 2.18, 95 % CI: 1.25-3.81). In treating focal epilepsy, CBM 300 mg was more effective at a 50 % response rate (SUCRA 91.8 %) compared with BRV and CBD. However, with the increase in dosage, more SAEs (SUCRA 85.6 %) appeared compared with other ASMs. CBD had good efficacy on LGS (SUCRA 88.4) and DS (SUCRA 66.2), but the effect on adult focal epilepsy was not better than that of placebo [vs placebo, RR = 0.83 (0.36-1.93)]. The NMA indicated that the likelihood of the most appropriate intervention (SUCRA 91.2 %) with minimum side effects（SUCRA 12.5 %）for the DS was FFM. Compared with CBD, high exposure to ELM demonstrated a more effective treatment of TSC (SUCRA 89.7 %). More high-quality SLT studies are needed to further evaluate the efficacy and safety. The comparison-adjusted funnel plots of annualized relapse rate and side effects in the included studies revealed no significant funnel plot asymmetry.

CONCLUSIONS:

This NMA indicated that the most effective treatment strategy for focal epilepsy, DS, Lennox-Gastaut syndrome, and TSC, respectively, included CBM 300 mg, FFM, CBD, and ELM. However, the aforementioned findings need further confirmation.

01 Apr 2024·Neurology and therapy

Conversion to Brivaracetam Monotherapy in Clinical Practice: A Retrospective Study

Article

Author: Boero, Giovanni ; Audenino, Daniela ; Foschi, Nicoletta ; Martellino, Chiara ; Lattanzi, Simona ; Bonanni, Paolo ; Ferrari, Alessandra ; Ferlazzo, Edoardo ; Piccioli, Marta ; Labate, Angelo ; Chiesa, Valentina ; Dainese, Filippo

INTRODUCTION:

The study aimed to evaluate the effectiveness and safety of brivaracetam (BRV) as conversion monotherapy in adults with focal epilepsy treated in the context of real-world clinical practice.

METHODS:

This was a retrospective, observational, non-interventional study in adults with focal epilepsy who converted to BRV monotherapy following the withdrawal of background antiseizure medications (ASMs). Primary effectiveness outcome was the retention rate of BRV as single ASM at 6 and 12 months. Secondary outcomes included the 6- and 12-month rates of seizure freedom. Safety and tolerability outcomes included the frequency and type of adverse events (AEs) and the occurrence of treatment discontinuation due to AEs.

RESULTS:

A total of 44 participants with a median age of 63.5 (interquartile range 44-73.5) years were included; 17 subjects were seizure free at baseline, and 9 of them switched from levetiracetam because of lack of tolerability. The retention rate of BRV monotherapy was 88.6% (39/44) at 6 months and 83.9% (26/31) at 12 months. The rates of seizure freedom were 72.7% (32/44) in subjects with 6-month follow-up and 58.1% (18/31) in subjects with 12-month follow-up. The median maintenance dosage of BRV monotherapy was 150 (100-200) mg/day at 6 months and 125 (100-200) mg/day in subjects with 12-month follow-up. Adverse events were recorded in 6/44 (13.6%) participants and led to BRV discontinuation in 2/44 (4.5%) cases. The reported AEs were somnolence (n = 3), fatigue (n = 2), and irritability (n = 1); no serious AEs were experienced. In 21/44 (47.7%) participants, BRV monotherapy resulted from the direct switch from levetiracetam. The rates of treatment retention and seizure freedom at 6 and 12 months were higher among people who switched from levetiracetam to BRV monotherapy.

CONCLUSION:

Brivaracetam may be a valuable treatment of focal seizures in people who converted to monotherapy in a real-life setting.

News (Medical) associated with Brivaracetam

29 Apr 2024

·www.fiercebiotech.com

Janssen-partnered epilepsy drug fails phase 2 trial in latest bad luck for Addex

It’s just the latest grim reading for Addex Therapeutics, which has seen its lead programs knocked back in the clinic one after the other. Addex Therapeutics’ run of bad luck in the clinic shows no sign of ending, as a Janssen-licensed epilepsy drug has failed to reduce the occurrence of seizures in a phase 2 trial. ADX71149 is a positive allosteric modulator (PAM) of metabotropic glutamate receptor-2 that emerged from a 2004 collaboration between Addex and Janssen. The Johnson & Johnson unit had been running a phase 2 trial that included 110 evaluable patients whose focal onset seizures had not been adequately controlled by the approved epilepsy meds levetiracetam or brivaracetam. Participants received either a 50-mg or a 100-mg dose of ADX71149 twice daily on top of their standard dose of levetiracetam or brivaracetam and up to three other anti-seizure drugs. The midstage study failed to demonstrate a delay in the time it took for patients to reach their baseline seizure count, missing the trial’s primary endpoint, Addex revealed in an April 29 release. This is just the latest grim reading for Addex, which has seen its lead programs knocked back in the clinic one after the other. In 2022, the company revealed that a phase 2a clinical trial designed to spearhead the expansion of dipraglurant, a negative allosteric modulator of metabotropic glutamate receptor-5, into muscle spasm disorders had delivered “inconclusive” data. That left the Geneva-based biotech looking to the drug to prove its worth in a Parkinson’s disease study. But COVID-19 headwinds soon blew that study off course as well, leaving Addex at risk of being delisted from Nasdaq. The company’s CEO Tim Dyer would later explain to Fierce Biotech how persuading investors about the potential of the Janssen collaboration for ADX71149 helped steady the ship during this stormy moment. Now, even ADX71149’s fate appears to be up in the air. Chief Medical Officer Roger Mills, M.D., outlined in today’s early morning release how the biotech will “work with our partner to determine next steps for the ADX71149 program.” Dyer’s own comments stuck to his strategy of trying to focus investors’ attention on the pipeline’s remaining potential. “While this is disappointing news for us and our partner, Janssen, we remain focused on advancing the rest of our portfolio of allosteric modulator programs towards clinical studies,” the CEO said in the release. “In particular, we are making great progress in our GABAB PAM collaboration with Indivior, which is on track to select drug candidates for [investigational new drug]-enabling studies in June this year for substance use disorder and chronic cough programs.” Investors didn’t appear to be reassured, with Addex’s stock dropping 50% to $8 in premarket trading on the Nasdaq Capital Market on Monday morning from a Friday closing price of $16.10. Should the Janssen partnership come to end, the majority of the 109 million euros ($117 million) in potential development and regulatory milestone payments tied to the deal will forever remain out of reach for Addex. Still, the biotech received a welcome show of faith in its allosteric modulator tech earlier this month, when investment firm Perceptive Advisors paid Addex 5 million euros ($5.4 million) to take a portfolio of preclinical assets and spin them out into a new company called Neurosterix that launched with $63 million in initial funding. Addex still has control of dipraglurant, which is being evaluated for dyskinesia associated with Parkinson’s and post-stroke/traumatic brain injury recovery. The company is also deciding on a PAM of the GABAB receptor to take forward in chronic cough. Indivior licensed a GABAB PAM program from Addex in 2018 with the aim of taking a candidate into clinical trials for substance use disorder.

Phase 2

29 Apr 2024

·www.globenewswire.com

Addex Provides Update on ADX71149 Phase 2 Epilepsy Study

Ad Hoc Announcement Pursuant to Art. 53 LR April 29, 2024 - Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, today announced top-line data from a Phase 2 epilepsy study evaluating adjunctive ADX71149 (JNJ-40411813) administration in patients with focal onset seizures with suboptimal response to levetiracetam or brivaracetam. The Phase 2 study did not achieve statistical significance for the primary endpoint of time for patients to reach baseline seizure count when ADX71149 was added to standard of care. “While disappointed that the Phase 2 ADX71149 epilepsy study did not meet the primary endpoint, we are still analyzing the data,” said Roger Mills, Chief Medical Officer of Addex. “We will provide details on data from the full study when this analysis is completed and will work with our partner to determine next steps for the ADX71149 program.” The data were reported from a total of 110 evaluable patients, who each received either 50 mg or 100 mg of ADX71149 twice daily (100 mg or 200mg twice daily, respectively, for patients receiving CYP3A4 inducing anti-seizure medication) in addition to their standard dose of levetiracetam or brivaracetam and up to three other anti-seizure drugs. Adjunctive administration of ADX71149 was safe and well tolerated. “While this is disappointing news for us and our partner, Janssen, we remain focused on advancing the rest of our portfolio of allosteric modulator programs towards clinical studies,” said Tim Dyer, CEO of Addex. “In particular, we are making great progress in our GABAB PAM collaboration with Indivior, which is on track to select drug candidates for IND enabling studies in June this year for substance use disorder and chronic cough programs.” ADX71149 is a selective metabotropic glutamate subtype 2 (mGlu2) receptor positive allosteric modulator (PAM). The multi-center Phase 2 study was designed to assess the efficacy, safety, tolerability, and pharmacokinetics of adjunctive ADX71149 administration in patients with focal onset seizures with suboptimal response to levetiracetam or brivaracetam. The primary objective of the study was to evaluate the efficacy of ADX71149 in combination with levetiracetam or brivaracetam using a time to baseline seizure count endpoint. Part 1 of the study evaluated the acute efficacy of ADX71149 over 4 weeks. Patients who did not reach their monthly baseline seizure count in Part 1 continued double-blind treatment during Part 2 until they reached their monthly baseline seizure count or 8 weeks, deemed the maintenance efficacy phase. More information on the study can be found with Clinicaltrials.gov identifier NCT04836559. Glutamate is the primary excitatory neurotransmitter in the brain and plays a key role in the initiation and spread of seizures. When activated, the mGlu2 receptor decreases the release of glutamate and consequently, helps to maintain neurotransmitter balance. In the presence of agonist-induced activation, positive allosteric modulation of mGlu2 receptors could result in the normalization of the excessive glutamate release seen during a seizure. Epilepsy remains a challenging unmet medical need, with a significant proportion of the patient population struggling in their day-to-day management of seizures. Under the research collaboration and license agreement, Addex granted Janssen Pharmaceuticals, Inc. an exclusive worldwide license to develop and commercialize mGlu2 PAM compounds. Addex is eligible for up to a total of €109 million in success-based development and regulatory milestone payments. In addition, Addex is eligible for low double-digit royalties on net sales of compounds developed under the agreement. Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders. Addex’s lead drug candidate, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals Inc., has recently completed a Phase 2 clinical study for the treatment of epilepsy. The Company’s second clinical program, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in dyskinesia associated with Parkinson’s disease and post-stroke/TBI recovery. Addex partnership with Indivior on GABAB PAM is advancing multiple drug candidates through clinical candidate selection for substance use disorder. Under the agreement with Indivior, Addex is advancing an independent GABAB PAM program for chronic cough through clinical candidate selection. Addex also holds a 20% share in a private company, Neurosterix LLC which is advancing a portfolio of allosteric modulator programs including M4PAM for schizophrenia, mGlu7NAM for stress related disorders and mGlu2NAM for mild neurocognitive disorders. Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are listed on the NASDAQ Capital Market, and trade under the ticker symbol “ADXN” on each exchange. For more information, visit www.addextherapeutics.com The content above comes from the network. if any infringement, please contact us to modify.

License out/inClinical Result

29 Apr 2024

·firstwordpharma.com

Addex stock battered after J&J-partnered drug fails mid-stage epilepsy study

Shares in Addex Therapeutics more than halved on Monday after the experimental drug ADX71149 – which stems from a long-term partnership with Johnson & Johnson – failed to meet the primary endpoint of a Phase II study in patients with epilepsy. Addex’s chief medical officer Roger Mills said that once further analysis of the data is completed, the company “will work with our partner to determine next steps for the…programme.”Addex joined forces with Johnson & Johnson back in 2004 to develop mGlu2 receptor positive allosteric modulators with ADX71149 - also known as JNJ-40411813 - being studied in a number of conditions, including major depressive disorder. However, results released around a decade ago did not support further work in this setting, and the focus subsequently shifted to epilepsy.The latest trial enrolled patients with focal onset seizures who have had a suboptimal response to levetiracetam or brivaracetam. Subjects were administered adjunctive ADX71149 in combination with levetiracetam or brivaracetam, with the study using a time to baseline seizure count endpoint for the main goal.Ahead of the readout, HC Wainwright analysts said they were “maintaining a cautious outlook until the Phase II data confirm the hypothesis underlying utility of this candidate in seizure-related conditions.”The caution seems justified as top-line data revealed that the trial did not achieve statistical significance for the primary endpoint. The results - which sent Addex’s down as much as 52% - were reported from a total of 110 evaluable patients, who each received either 50mg or 100mg of ADX71149 twice daily.

Phase 2Clinical Result

100 Deals associated with Brivaracetam

External Link

KEGG	Wiki	ATC	Drug Bank
D08879	Brivaracetam	N03AX23	DB05541

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Epilepsy	US	UCB, Inc.	18 Feb 2016
Epilepsies, Partial	EU	UCB Pharma SA	13 Jan 2016
Epilepsies, Partial	IS	UCB Pharma SA	13 Jan 2016
Epilepsies, Partial	LI	UCB Pharma SA	13 Jan 2016
Epilepsies, Partial	NO	UCB Pharma SA	13 Jan 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Epilepsy, Absence	Phase 3	US	UCB Biopharma SRL	29 Jul 2021
Epilepsy, Absence	Phase 3	AU	UCB Biopharma SRL	29 Jul 2021
Epilepsy, Absence	Phase 3	BE	UCB Biopharma SRL	29 Jul 2021
Epilepsy, Absence	Phase 3	GE	UCB Biopharma SRL	29 Jul 2021
Epilepsy, Absence	Phase 3	IT	UCB Biopharma SRL	29 Jul 2021
Epilepsy, Absence	Phase 3	PL	UCB Biopharma SRL	29 Jul 2021
Epilepsy, Absence	Phase 3	RO	UCB Biopharma SRL	29 Jul 2021
Epilepsy, Absence	Phase 3	SK	UCB Biopharma SRL	29 Jul 2021
Epilepsy, Absence	Phase 3	ES	UCB Biopharma SRL	29 Jul 2021
Epilepsy, Absence	Phase 3	UA	UCB Biopharma SRL	29 Jul 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05315947 (CTgov)	Phase 1	-	24	BRV (BRV Tablet)	ereawcteve(kepulytlyx) = urrgqaisib dgmbqbkxtt (arsyczrzcs, zqzcwzoifh - gcarhuuwie) View more	-	05 Jan 2024
				BRV (BRV Dry Syrup)	ereawcteve(kepulytlyx) = boxvcoafqm dgmbqbkxtt (arsyczrzcs, swzzbiputp - pcsqocqpiq) View more
NCT03083665 (CTgov)	Phase 3	Epilepsies, Partial \| Seizures	449	Placebo (Placebo)	tbeqcsyswp(ztygqcxiib) = ysgkhbfzud szegcykzff (atembmmxrv, ampbihgaum - ckrizjyewa) View more	-	09 Nov 2023
				Placebo+Brivaracetam (BRV 50 mg/Day)	tbeqcsyswp(ztygqcxiib) = kipnzgguns szegcykzff (atembmmxrv, hsmvhfqahf - heblvemdln) View more
NCT01364597 (N01266, Pubmed)	Phase 3	Epilepsy	257	Adjunctive brivaracetam	vilyhwozcd(hwxcurniyr) = ojptiqwuct kiaybaucfz (mjhjpikwjz )	-	01 Nov 2023
AAN2023	Not Applicable	-	254	Brivaracetam	jnevwkswan(wqlwrhrwwn) = welbdrezzc twnrerltua (wrvhufpzlw ) View more	Positive	25 Apr 2023
				Brivaracetam	jnevwkswan(wqlwrhrwwn) = wtsjdtduih twnrerltua (wrvhufpzlw ) View more
P11-1.003 (AAN2023)	Not Applicable	-	1,644	Brivaracetam	opaxmvkbry(fwdmhvingk) = 1.6%/0.8%/0.6% at 3/6/12 months hzdpyjvkvj (jkusgeoxtf ) View more	Positive	25 Apr 2023
P11-1.010 (AAN2023)	Not Applicable	Seizures	720	1-2 lifetime ASMs	wjgruodlju(dlzwmfdxcj) = cyfniqrgcr cmqduexwzw (rpsfahivbk ) View more	Positive	25 Apr 2023
				3-4 lifetime ASMs	wjgruodlju(dlzwmfdxcj) = zuglfapiss cmqduexwzw (rpsfahivbk ) View more
NCT04882540 (CTgov)	Phase 1	-	12	brivaracetam	daxdtauwdg(vxrbhrfyqe) = vylsnbircd cmolsrzhtw (tjblhyjsmv, lrohcsblpb - slppxbfjov) View more	-	13 Mar 2023
NCT01261325 (N01358, Pubmed)	Phase 3	Seizures	768	Adjunctive brivaracetam	qmtmttsvcb(nkpqasglhb) = ayxdunnlgi stvsykhfny (rczvliogrp ) View more	-	23 Nov 2022
				Placebo	qmtmttsvcb(nkpqasglhb) = vjzepvzdmo stvsykhfny (rczvliogrp ) View more
NCT01364597 (CTgov)	Phase 3	Epilepsy	257	Brivaracetam (BRV) (Age Cohort: ≥1 Month to <2 Years)	zftoelmmmi(rumxqlxspr) = gcwbjbubpp kcnaoiemyn (eiyqsfmzdi, zicqpjbodh - qqflvmcllj) View more	-	29 Aug 2022
				BRV (Age Cohort: ≥2 to <4 Years)	zftoelmmmi(rumxqlxspr) = ilnqhwgtkh kcnaoiemyn (eiyqsfmzdi, szvbqisali - nilmgpeaqs) View more
NCT00490035 \| NCT00464269 \| NCT01261325 (N01252/NCT00490035, N01253/NCT00464269, N01358/NCT01261325, Pubmed \| Turk J Pediatr)	Phase 3	Seizures	-	Brivaracetam	bqyyjgyjbj(hbserwiuim) = ixnuuuycss azwydfnjmi (egviytrcly ) View more	Positive	17 May 2022
				Placebo	bqyyjgyjbj(hbserwiuim) = ldqcrgzoxp azwydfnjmi (egviytrcly ) View more

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