NCT00368251 is a Phase 3 clinical trial of BRV 2.5 mg in Unverricht-Lundborg Disease, sponsored by UCB Pharma.

Who is sponsoring NCT00368251?

NCT00368251 is sponsored by UCB Pharma.

What drugs are being tested in NCT00368251?

Interventions in NCT00368251: Placebo, BRV 2.5 mg, BRV 25 mg, BRV 50 mg.

What condition does NCT00368251 study?

NCT00368251 studies Unverricht-Lundborg Disease.

Is NCT00368251 still recruiting?

NCT00368251 is currently completed. Last updated 3 May 2023.

Are results published for NCT00368251?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-05-03 · How we verify

NCT00368251

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment for 12 Weeks in Adolescent and Adult Patients (≥ 16 Years) With Genetically Ascertained Unverricht-Lundborg Disease

Completed Phase 3 Results posted Last updated 3 May 2023

What this trial tests

Phase 3 trial testing Placebo in Unverricht-Lundborg Disease in 56 participants. Completed in 1 January 2008.

Timeline

1 November 2006

Primary endpoint
1 January 2008

1 January 2008

Quick facts

Lead sponsor	UCB Pharma
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	56
Start date	1 November 2006
Primary completion	1 January 2008
Estimated completion	1 January 2008
Sites	18 locations across United States, Canada, Finland, France, Israel, Russia, Serbia, Tunisia

Drugs / interventions tested

Placebo
BRV 2.5 mg — full drug profile →
BRV 25 mg — full drug profile →
BRV 50 mg — full drug profile →

Conditions studied

Unverricht-Lundborg Disease — all drugs for Unverricht-Lundborg Disease →

Sponsor

UCB Pharma — full company profile →

Who can join

16 and older, any sex, with Unverricht-Lundborg Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percent Change From Baseline to the End of Treatment Period on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4)
Time frame: From Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)
The range for Action Myoclonus Score (centrally read) is 0 (best) - 160 (worst). Percent change from Baseline = 100 X ((Baseline UMRS4 - Treatment UMRS4) / Baseline UMRS4). Baseline is defined as the last non-missing value prior to or on Randomization Visit.

Sponsor's own description

The study will compare the efficacy and safety of Brivaracetam with placebo in patients with Unverricht- Lundborg Disease (ULD).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

A review of the pharmacology and clinical efficacy of brivaracetam.
Klein P, Diaz A, Gasalla T, Whitesides J. · · 2018 · cited 67× · PMID 29403319 · DOI 10.2147/cpaa.s114072
Brivaracetam in Unverricht-Lundborg disease (EPM1): Results from two randomized, double-blind, placebo-controlled studies.
Kälviäinen R, Genton P, Andermann E, Andermann F, et al · · 2016 · cited 40× · PMID 26666500 · DOI 10.1111/epi.13275
Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial.
Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, et al · · 2021 · cited 13× · PMID 33461041 · DOI 10.1016/j.eplepsyres.2020.106526

Verify or expand the search:

Other recruiting trials for Unverricht-Lundborg Disease

Currently open trials in the same condition.

NCT06593951 — Registry and Natural History Study for Progressive Myoclonus Epilepsy Type 1 (EPM1) · recruiting

Other UCB Pharma trials

Trials by the same sponsor.

NCT01969851 — A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Mo · Phase 2 · completed
NCT01921205 — Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures · Phase 3 · completed
NCT01095393 — National Data Bank for Rheumatic Disease Registry Study of Safety in Patients With Rheumatoid Arthritis Treated With Cim · completed
NCT00350103 — A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy · Phase 3 · completed
NCT00291668 — Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00368251 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UCB Pharma
Last refreshed: 3 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00368251.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing