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Epilepsy, FocalPhase 2NCT00175929

A Study of Brivaracetam in Subjects With Partial Onset Seizures

A Phase 2 study testing Brivaracetam in people with Epilepsy, Focal, run by UCB Pharma at 56 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150 mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy Read more about this study

Who is it for?
Ages 16 to 65 years
Conditions the study is for
Epilepsy, Focal
What is being tested?
Brivaracetam
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
157 participants
Where
56 sitesin 9 countries
Study dates
May 2005to Mar 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
  • Subjects with a history of partial onset seizures
  • Subjects having at least 4 partial onset seizures during the Baseline period and at least 2 partial onset seizures per month during the 3 months preceding Visit 1
  • Subjects being uncontrolled while treated by 1 or 2 concomitant Antiepileptic drug(s) AED(s) being stable
  • Male/ female subjects from 16 to 65 years, both inclusive. Subjects under 18 years may only be included where legally permitted and ethically accepted

Who cannot join

  • Seizure type IA non-motor as only seizure type
  • History or presence of seizures occurring only in clustered patterns
  • History of cerebrovascular accident (CVA)
  • Presence of any sign suggesting rapidly progressing brain disorder or brain tumor

Trial locations and contacts

56 sites in 9 countries.

56 sites in 9 countries

France14 sites

  • Study site

    Angers

  • Study site

    Béthune

  • Study site

    Dijon

  • Study site

    Grenoble

  • Study site

    Lille

  • Study site

    Lyon

  • Study site

    Marseille

  • Study site

    Montpellier

  • Study site

    Nancy

  • Study site

    Paris

  • Study site

    Rennes

  • Study site

    Strasbourg

  • Study site

    Tain-l'Hermitage

  • Study site

    Toulouse

Other trials in France

Germany11 sites

  • Study site

    Berlin

  • Study site

    Bielefeld

  • Study site

    Bonn

  • Study site

    Chemnitz

  • Study site

    Erlangen

  • Study site

    Essen

  • Study site

    Frankfurt

  • Study site

    Freiburg im Breisgau

  • Study site

    Kehl

  • Study site

    München

  • Study site

    Ulm

Other trials in Germany

United Kingdom7 sites

  • Study site

    Bucks

  • Study site

    Cambridge

  • Study site

    Cardiff

  • Study site

    Glasgow

  • Study site

    Hartshill

  • Study site

    Liverpool

  • Study site

    Newcastle

Other trials in United Kingdom

Belgium6 sites

  • Study site

    Bruges

  • Study site

    Brussels

  • Study site

    Duffel

  • Study site

    Edegem

  • Study site

    Leuven

  • Study site

    Liège

Other trials in Belgium

Poland6 sites

  • Study site

    Gdansk

  • Study site

    Katowice

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Szczecin

  • Study site

    Warsaw

Other trials in Poland

Czechia4 sites

  • Study site

    Beroun

  • Study site

    Brno

  • Study site

    České Budějovice

  • Study site

    Prague

Other trials in Czechia

Finland3 sites

  • Study site

    Kuopio

  • Study site

    Oys (Oulu)

  • Study site

    Tampere

Other trials in Finland

Spain3 sites

  • Study site

    Madrid

  • Study site

    Valencia

  • Study site

    Vigo

Other trials in Spain

Netherlands2 sites

  • Study site

    Heemstede

  • Study site

    Heeze

Other trials in Netherlands

About this study

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, 3 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Ucb 34714 Used as Adjunctive Treatment at Doses of 50 and 150 mg/Day in b.i.d. Administration (Oral Capsules of 25 mg) for a Maximum of 12 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized

This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150 mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy

Conditions
Epilepsy, Focal
Being tested
Placebo, Brivaracetam
Keywords
Epilepsy, Focal Epilepsy, Partial Onset Seizures, Brivaracetam
Medical subject headings
Epilepsies, Partial, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboOther

    Daily oral dose of two equal intakes, morning and evening, of placebo in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)

  • BrivaracetamDrug

    Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)

  • BrivaracetamDrug

    Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 150 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)

Study groups in NCT00175929
Study groupRoleWhat they receive
PlaceboPlacebo comparatorMatching placebo tablets administered twice a day
Receives: Other: Placebo
Brivaracetam 50 mg/dayExperimentalBrivaracetam 50 mg/day, 25 mg administered twice a day
Receives: Drug: Brivaracetam
Brivaracetam 150 mg/dayExperimentalBrivaracetam 150 mg/day, 75 mg administered twice a day
Receives: Drug: Brivaracetam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Partial onset seizure frequency (Type I) per week over the 7-week maintenance period

    Partial onset seizure frequency (Type I) per week over the 7-week maintenance period

    Measured: 7-week maintenance period

Secondary outcomes (8)

  1. Seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period

    Measured: During the Maintenance period (approximately 7 weeks)

  2. Percentage of reduction from Baseline in seizure frequency per week for partial onset seizures (type I) over the 7-week Maintenance period

    Measured: During the Maintenance period (approximately 7 weeks)

  3. Percentage of reduction from Baseline in seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period

    Measured: During the Maintenance period (approximately 7 weeks)

  4. Responder rate in partial onset seizures (type I) over the 7-week Maintenance period

    A responder was defined as a subject with a ≥ 50% reduction in seizure frequency per week from the Baseline period to the Maintenance period.

    Measured: During the Maintenance period (approximately 7 weeks)

  5. Response to treatment in partial onset seizures (type I) over the 7-week Maintenance period

    The percentage reduction from Baseline in partial seizure frequency per week over the Maintenance period was grouped in 5 categories: < -25%, -25% to < 25%, 25% to < 75%, 75% to ≤ 100%, and 100%.

    Measured: During the Maintenance period (approximately 7 weeks)

  6. Percentage of seizure-free subjects over the 7-week Maintenance period

    Measured: During the Maintenance period (approximately 7 weeks)

  7. Percentage of seizure-free days per 4 weeks over Baseline and Maintenance periods

    Measured: Baseline through Maintenance period (approximately 11 weeks)

  8. Time to N-th seizure in the Maintenance period

    Measured: During the Maintenance period (approximately 7 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionMar 2006
  4. Study completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
157 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00175929
Sponsor's protocol ID
N01114
Other IDs
2004-001856-35, 2004
Status last verified
Apr 2015
First submitted
9 Sep 2005
Last updated
13 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Bresnahan R, Panebianco M, Marson AG. Brivaracetam add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2022 Mar 14;3(3):CD011501. doi: 10.1002/14651858.CD011501.pub3.

    PubMed 35285519

  • Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. 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. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.

    PubMed 33461041

  • Brandt C, Klein P, Badalamenti V, Gasalla T, Whitesides J. Safety and tolerability of adjunctive brivaracetam in epilepsy: In-depth pooled analysis. Epilepsy Behav. 2020 Feb;103(Pt A):106864. doi: 10.1016/j.yebeh.2019.106864. Epub 2020 Jan 12.

    PubMed 31937513

  • Van Paesschen W, Hirsch E, Johnson M, Falter U, von Rosenstiel P. Efficacy and tolerability of adjunctive brivaracetam in adults with uncontrolled partial-onset seizures: a phase IIb, randomized, controlled trial. Epilepsia. 2013 Jan;54(1):89-97. doi: 10.1111/j.1528-1167.2012.03598.x. Epub 2012 Jul 19.

    PubMed 22813235

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brivaracetam in people with Epilepsy, Focal, run by UCB Pharma at 56 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in France, Germany, United Kingdom, Belgium, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Partial onset seizure frequency (Type I) per week over the 7-week maintenance period (time frame: 7-week maintenance period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00175929, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2015.

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