Brief Summary

The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16 years and older with epilepsy. This study permits continued access to treatment for subjects who participated in a previous epilepsy study. The study will explore the long-term safety and efficacy of brivaracetam.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

108

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Nov 2008

Longer than P75 for phase_3

Geographic Reach

11 countries

58 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.3 years study duration

First Submitted

Initial submission to the registry

September 26, 2008

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed

1 month until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed

8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

April 23, 2018

Completed

Last Updated

July 11, 2018

Status Verified

March 1, 2018

Enrollment Period

8.3 years

First QC Date

September 26, 2008

Results QC Date

March 20, 2018

Last Update Submit

June 13, 2018

Conditions

Epilepsy

Keywords

EpilepsyMonotherapyPartial Onset Seizures

Outcome Measures

Primary Outcomes (3)

Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)
Treatment-emergent Adverse events (TEAE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.
During the Evaluation Period (up to 9 years)
Percentage of Subjects Who Withdrew Due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)
Adverse Events (AE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.
During the Evaluation Period (up to 9 years)
Percentage of Subjects With a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)
An SAE was any untoward medical occurrence that, at any dose resulted in death, was life threatening, required in-subject hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
During the Evaluation Period (up to 9 years)

Secondary Outcomes (3)

Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 3 Months of the Evaluation Period (up to 9 Years)
During the Evaluation Period (up to 9 years)
Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 6 Months, of the Evaluation Period (up to 9 Years)
During the Evaluation Period (up to 9 years)
Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 12 Months of the Evaluation Period (up to 9 Years)
During the Evaluation Period (up to 9 years)

Study Arms (1)

Brivaracetam

EXPERIMENTAL

Brivaracetam at flexible dosing up to 200mg /day

Drug: Brivaracetam

Interventions

BrivaracetamDRUG

Subjects will begin at a recommended dose of Brivaracetam 100 mg/day. Subjects will continue treatment at a dose up to a maximum of 200 mg/day with a twice per day administration. Up- and down-titration steps may be performed in steps of a maximum of 50 mg/day on a weekly basis. Full down-titration should include a one week step on 20 mg/day. The study medication will come in 10 mg and 25 mg tablet strengths.

Also known as: ucb 34714

Brivaracetam

Eligibility Criteria

Age16 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Subjects with epilepsy who participated in previous brivaracetam trials which allow access to the present trial.
Subjects from whom the Investigator believes a reasonable potential benefit from the long-term administration of brivaracetam may be expected.

You may not qualify if:

Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behaviour, or laboratory values which may have an impact on the safety of the subject, as determined by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

UCB Pharmalead

Study Sites (58)

304

Phoenix, Arizona, United States

Location

281

Fresno, California, United States

Location

288

Pasadena, California, United States

Location

240

Riverside, California, United States

Location

245

Sacramento, California, United States

Location

285

Peoria, Illinois, United States

Location

224

Indianapolis, Indiana, United States

Location

266

Lexington, Kentucky, United States

Location

231

Waldorf, Maryland, United States

Location

278

Burlington, Massachusetts, United States

Location

270

New York, New York, United States

Location

284

Hickory, North Carolina, United States

Location

241

Columbus, Ohio, United States

Location

265

Oklahoma City, Oklahoma, United States

Location

297

Germantown, Tennessee, United States

Location

260

Austin, Texas, United States

Location

236

Bedford, Texas, United States

Location

267

Dallas, Texas, United States

Location

268

Houston, Texas, United States

Location

211

Layton, Utah, United States

Location

235

Ogden, Utah, United States

Location

218

Burlington, Vermont, United States

Location

279

Danville, Virginia, United States

Location

277

Charleston, West Virginia, United States

Location

213

Marshfield, Wisconsin, United States

Location

400

Chatswood, New South Wales, Australia

Location

404

Adelaide, South Australia, Australia

Location

402

Fitzroy, Victoria, Australia

Location

401

Parkville, Victoria, Australia

Location

004

Ghent, Belgium

Location

003

Kortrijk, Belgium

Location

205

Calgary, Alberta, Canada

Location

203

Edmonton, Alberta, Canada

Location

206

Toronto, Ontario, Canada

Location

023

Brno, Czechia

Location

020

Litomyšl, Czechia

Location

021

Ostava, Czechia

Location

024

Ostrava-Trebovice, Czechia

Location

026

Prague, Czechia

Location

040

Béthune, France

Location

041

Toulouse, France

Location

055

Berlin, Germany

Location

056

Bernau, Germany

Location

054

Bielefeld, Germany

Location

063

Mainz, Germany

Location

051

München, Germany

Location

065

Regensburg, Germany

Location

072

Budapest, Hungary

Location

074

Budapest, Hungary

Location

084

Bergamo, Italy

Location

082

Messina, Italy

Location

085

Orbassano, Italy

Location

083

Perugia, Italy

Location

080

Pisa, Italy

Location

090

Madrid, Spain

Location

100

Gothenburg, Sweden

Location

102

Lund, Sweden

Location

101

Stockholm, Sweden

Location

Related Publications (1)

Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.
PMID: 26899665DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

brivaracetam

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title: UCB
Organization: Cares

Study Officials

UCB Cares
+1 844 599 2273(UCB)
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR
Expanded Access: Yes

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 30, 2008

Study Start

November 1, 2008

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

July 11, 2018

Results First Posted

April 23, 2018

Record last verified: 2018-03

Locations

ES(1)CA(3)BE(2)CZ(5)FR(2)SE(3)US(25)DE(6)AU(4)HU(2)IT(5)

An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (1)

Brivaracetam

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (58)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (1)

Brivaracetam

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (58)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations