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EpilepsyPhase 2NCT00175825

A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.

A Phase 2 study testing Brivaracetam in people with Epilepsy, run by UCB Pharma at 42 sites in 4 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 5, 20 and 50 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
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
210 participants
Where
42 sitesin 4 countries
Study dates
7 Nov 2005to 29 Jun 2006
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Male/female from 16 to 65 years
  • Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
  • History of partial onset seizures
  • Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1
  • Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.

Who cannot join

  • Seizure type IA non-motor as only seizure type
  • Seizures occurring only in clusters
  • Status epilepticus during the last 2 years before Visit 1
  • History of cerebrovascular accident (CVA)
  • Presence of any sign suggesting rapidly progressing brain disorder or brain tumor

Trial locations and contacts

42 sites in 4 countries.

42 sites in 4 countries

United States26 sites

  • Study site

    Bethesda, Maryland

  • Study site

    Bradenton, Florida

  • Study site

    Burlington, Massachusetts

  • Study site

    Chesterfield, Missouri

  • Study site

    Chicago, Illinois

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Englewood Cliffs, New Jersey

  • Study site

    Fresno, California

  • Study site

    Grand Rapids, Michigan

  • Study site

    Great Falls, Montana

  • Study site

    Greenville, South Carolina

  • Study site

    Houston, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Little Rock, Arkansas

  • Study site

    New York, New York

  • Study site

    Paducah, Kentucky

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Rochester, Minnesota

  • Study site

    Ruston, Louisiana

  • Study site

    Salt Lake City, Utah

  • Study site

    Toms River, New Jersey

  • Study site

    Tupelo, Mississippi

  • Study site

    Wilmington, North Carolina

  • Study site

    Woonsocket, Rhode Island

Other trials in United States

Mexico8 sites

  • Study site

    Aguascalientes

  • Study site

    Chichuahua

  • Study site

    Chihuahua City

  • Study site

    Guadalajara

  • Study site

    Monterrey

  • Study site

    San Luis Potosí City

  • Study site

    Valle Oriente Garza Garcia

  • Study site

    Zapopan

Other trials in Mexico

India5 sites

  • Study site

    Bangalore

  • Study site

    Hyderabad

  • Study site

    Lucknow

  • Study site

    Parel Mumbai

  • Study site

    Trivandrum

Other trials in India

Brazil3 sites

  • Study site

    Florianópolis

  • Study site

    Salvador

  • Study site

    São Paulo

Other trials in Brazil

About this study

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, 4 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment at Doses of 5, 20 and 50 mg/Day in b.i.d. Administration (Oral Tablets of 2.5 or 10 mg) for a Maximum of 7 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 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.

Conditions
Epilepsy
Being tested
Placebo, Brivaracetam
Keywords
Epilepsy: partial onset seizures, brivaracetam
Medical subject headings
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 7-week Treatment Period

  • BrivaracetamDrug

    Also called Briviact

    Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period

Study groups in NCT00175825
Study groupRoleWhat they receive
PlaceboPlacebo comparatorMatching Placebo tablets administered twice a day
Receives: Other: Placebo
Brivaracetam 5 mg/dayExperimentalBrivaracetam 5 mg/day, 2.5 mg administered twice a day
Receives: Drug: Brivaracetam
Brivaracetam 20 mg/dayExperimentalBrivaracetam 20 mg/day, 10 mg administered twice a day
Receives: Drug: Brivaracetam
Brivaracetam 50 mg/dayExperimentalBrivaracetam 50 mg/day, 25 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 Per Week During the 7-week Treatment Period

    Calculated as 7-day partial onset seizure frequency.

    Measured: During the 7-week Treatment Period

Secondary outcomes (10)

  1. Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period

    Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.

    Measured: Baseline, during the 7-week Treatment Period

  2. Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period

    Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period.

    Measured: During the 7-week Treatment Period

  3. Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period

    Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.

    Measured: During the 7-week Treatment Period

  4. Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period

    Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.

    Measured: During the 7-week Treatment Period

  5. Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period

    Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.

    Measured: During the 7-week Treatment Period

  6. Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period

    A responder was defined as a subject with a >= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period.

    Measured: During the 7-week Treatment Period

  7. Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period

    Categories of percentage reductions in seizures from baseline were as following: < -25 %; -25 % to <25 %; 25 % to <75 %; 75 % to <100 %; 100 %.

    Measured: During the 7-week Treatment Period

  8. Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period

    A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period.

    Measured: During the 7-week Treatment Period

  9. Number of Seizure-free Days Per 4 Weeks

    A day was considered seizure-free, if no seizure was reported during 24 hours.

    Measured: Baseline, during the 7-week Treatment Period

  10. Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period

    Number of days to first, fifth, and tenth seizure after baseline.

    Measured: During the 7-week Treatment Period

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 start7 Nov 2005
  3. Primary completion29 Jun 2006
  4. Study completion29 Jun 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
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00175825
Sponsor's protocol ID
N01193
Status last verified
Sep 2018
First submitted
9 Sep 2005
Last updated
2 Oct 2018
Data monitoring committee
No

Publications

  • Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. doi: 10.1111/epi.13416. Epub 2016 Jun 6.

    PubMed 27265725

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brivaracetam in people with Epilepsy, run by UCB Pharma at 42 sites in 4 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 5 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 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Mexico, India, Brazil. 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?

Yes. Results are posted in the registry (first posted 22 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Per Week During the 7-week Treatment Period (time frame: During the 7-week Treatment 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 NCT00175825, which also lists 3 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 2 Oct 2018.

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