This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment

NCT00150800 | Completed Phase 3 Results

• 1 other identifier: N01199
• Study Type: interventional
• Target: 668
• Locations: 6 countries
• Sites: 100

Brief Summary

This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.

Conditions

Epilepsy

Keywords

Brivaracetam; Epilepsy; Partial Onset Seizures; open label

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period

  Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.

  Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)

• Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period

  Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.

  Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)

• Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period

  A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.

  Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)

Secondary Outcomes (3)

• Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period

  From Baseline of the previous study to the Evaluation Period (up to 11 years)

• Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period

  From Baseline of the previous study to the Evaluation Period (up to 11 years)

• Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period

  From Baseline of the previous study to the Evaluation Period (up to 11 years)

Study Arms (1)

Brivaracetam

EXPERIMENTAL

Brivaracetam used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg/day on a weekly basis.

Drug: Brivaracetam

Interventions

Brivaracetam DRUG

* Active Substance: Brivaracetam * Pharmaceutical Form: Tablet * Concentration: 10 mg and 25 mg * Route of Administration: Oral

Brivaracetam

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/ female subjects from 16 years and on. Subjects under 18 years may only be included where legally permitted and ethically accepted
• Subjects with epilepsy who have participated in previous brivaracetam trials which allow access to the present study
• Subjects for whom the investigator believes a reasonable benefit from the long term administration of brivaracetam may be expected
• Female subjects without childbearing potential. Female subjects with child bearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study
• Subject/ legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator

You may not qualify if:

• Severe medical, neurological and psychiatric disorders or laboratory values which may have an impact on the safety of the subject
• Poor compliance with the visit schedule or medication intake in the previous brivaracetam study
• Pregnant or lactating women
• Participation in any clinical study of another investigational drug or device during the study

Sponsors & Collaborators

• UCB PHARMA Inc. (US): lead

Study Sites (100)

N01199 1051

Phoenix, Arizona, United States

Location

N01199 1362

Phoenix, Arizona, United States

Location

N01199 1374

Tucson, Arizona, United States

Location

N01199 1050

Little Rock, Arkansas, United States

Location

N01199 1078

Fresno, California, United States

Location

N01199 1392

Newport Beach, California, United States

Location

N01199 1087

San Francisco, California, United States

Location

N01199 1368

San Francisco, California, United States

Location

N01199 1396

Atlanta, Georgia, United States

Location

N01199 1385

Augusta, Georgia, United States

Location

N01199 1356

Chicago, Illinois, United States

Location

N01199 1388

Springfield, Illinois, United States

Location

N01199 1375

Wichita, Kansas, United States

Location

N01199 1364

Lexington, Kentucky, United States

Location

N01199 1380

Louisville, Kentucky, United States

Location

N01199 1052

Paducah, Kentucky, United States

Location

N01199 1083

Ruston, Louisiana, United States

Location

N01199 1373

Baltimore, Maryland, United States

Location

N01199 1086

Bethesda, Maryland, United States

Location

N01199 1077

Burlington, Massachusetts, United States

Location

N01199 1391

Detroit, Michigan, United States

Location

N01199 1395

Detroit, Michigan, United States

Location

N01199 1071

Grand Rapids, Michigan, United States

Location

N01199 1389

Saint Paul, Minnesota, United States

Location

N01199 1079

Tupelo, Mississippi, United States

Location

N01199 1360

Chesterfield, Missouri, United States

Location

N01199 1352

St Louis, Missouri, United States

Location

N01199 1069

Great Falls, Montana, United States

Location

N01199 1062

Toms River, New Jersey, United States

Location

N01199 1053

New York, New York, United States

Location

N01199 1365

Rochester, New York, United States

Location

N01199 1366

Cincinnati, Ohio, United States

Location

N01199 1054

Columbus, Ohio, United States

Location

N01199 1359

Portland, Oregon, United States

Location

N01199 1055

Philadelphia, Pennsylvania, United States

Location

N01199 1059

Philadelphia, Pennsylvania, United States

Location

N01199 1081

Greenville, South Carolina, United States

Location

N01199 1061

Nashville, Tennessee, United States

Location

N01199 1084

Dallas, Texas, United States

Location

N01199 1394

Dallas, Texas, United States

Location

N01199 1064

Houston, Texas, United States

Location

N01199 1082

Salt Lake City, Utah, United States

Location

N01199 1367

Charlottesville, Virginia, United States

Location

N01199 1393

Richmond, Virginia, United States

Location

N01199 1376

Seattle, Washington, United States

Location

N01199 1369

Milwaukee, Wisconsin, United States

Location

N01199 1420

Chatswood, New South Wales, Australia

Location

N01199 1430

Randwick, New South Wales, Australia

Location

N01199 1423

Adelaide, South Australia, Australia

Location

N01199 1428

Woodville, South Australia, Australia

Location

N01199 1427

Clayton, Victoria, Australia

Location

N01199 1426

Parkville, Victoria, Australia

Location

N01199 1421

West Heidelberg, Victoria, Australia

Location

N01199 1422

Fitzroy, Australia

Location

N01199 1028

Campinas, Brazil

Location

N01199 1325

Curitiba, Brazil

Location

N01199 1024

Florianópolis, Brazil

Location

N01199 1150

Florianópolis, Brazil

Location

N01199 1331

Porto Alegre, Brazil

Location

N01199 1332

Porto Alegre, Brazil

Location

N01199 1022

Riberao Preto, Brazil

Location

N01199 1023

Salvador, Brazil

Location

N01199 1029

São José do Rio Preto, Brazil

Location

N01199 1021

São Paulo, Brazil

Location

N01199 1027

São Paulo, Brazil

Location

N01199 1030

São Paulo, Brazil

Location

N01199 1326

São Paulo, Brazil

Location

N01199 1316

Edmonton, Alberta, Canada

Location

N01199 1312

Greenfield Park, Quebec, Canada

Location

N01199 1311

Montreal, Quebec, Canada

Location

N01199 1314

Montreal, Quebec, Canada

Location

N01199 1313

Québec, Quebec, Canada

Location

N01199 1266

Mumbai, Maharashti, India

Location

N01199 1045

Bangalore, India

Location

N01199 1256

Bangalore, India

Location

N01199 1257

Bangalore, India

Location

N01199 1261

Bangalore, India

Location

N01199 1046

Chennai, India

Location

N01199 1042

Hyderabad, India

Location

N01199 1253

Hyderabad, India

Location

N01199 1262

Hyderabad, India

Location

N01199 1258

Jaipur, India

Location

N01199 1040

Lucknow, India

Location

N01199 1250

Lucknow, India

Location

N01199 1043

Mumbai, India

Location

N01199 1259

Mumbai, India

Location

N01199 1265

Parel Mumbai, India

Location

N01199 1251

Pune, India

Location

N01199 1264

Pune Maharashtra, India

Location

N01199 1263

Tirupati, India

Location

N01199 1412

San Nicholas de Los Garza, Nuevo León, Mexico

Location

N01199 1010

Aguascalientes, Mexico

Location

N01199 1008

Chihuahua City, Mexico

Location

N01199 1009

Chihuahua City, Mexico

Location

N01199 1003

Guadalajara, Mexico

Location

N01199 1403

Mexico City, Mexico

Location

N01199 1005

Monterrey, Mexico

Location

N01199 1007

Monterrey, Mexico

Location

N01199 1002

San Luis Potosí City, Mexico

Location

N01199 1001

Zapopan, Mexico

Location

Related Publications (3)

• O'Brien TJ, Borghs S, He QJ, Schulz AL, Yates S, Biton V. Long-term safety, efficacy, and quality of life outcomes with adjunctive brivaracetam treatment at individualized doses in patients with epilepsy: An up to 11-year, open-label, follow-up trial. Epilepsia. 2020 Apr;61(4):636-646. doi: 10.1111/epi.16484. Epub 2020 Mar 28.

  PMID: 32221987 RESULT

• Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.

  PMID: 34218211 RESULT

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

  PMID: 26899665 DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

brivaracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1844 599

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 6, 2005
• First Posted: September 8, 2005
• Study Start: January 1, 2006
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: August 17, 2021
• Results First Posted: December 5, 2018

Record last verified: 2021-08

Locations

CA (5); IN (18); AU (8); ME (10); US (46); BR (13)