Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy

NCT01339559 | Completed Phase 3 Results

• 2 other identifiers: N013792010-020345-27
• Study Type: interventional
• Target: 767
• Locations: 27 countries
• Sites: 181

Brief Summary

This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).

Conditions

Epilepsy

Keywords

Epilepsy; Brivaracetam; Partial Onset Seizures; Adjunctive treatment

Outcome Measures

Primary Outcomes (3)

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

  Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.

  From Entry Visit (Month 0) until the Last Visit (up to 84 months)

• Percentage of Participants Who Withdrew Due to Adverse Events (AEs)

  An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

  From Entry Visit (Month 0) until the Last Visit (up to 84 months)

• Percentage of Participants With at Least One Serious Adverse Event (SAE)

  A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is as infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.

  From Entry Visit (Month 0) until the Last Visit (up to 84 months)

Secondary Outcomes (3)

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

  From Baseline of the previous study until the Last Visit (up to 84 months)

• 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 until the Last Visit (up to 84 months)

• Responder Rate in POS (Type I) Frequency Over the Evaluation Period

  From Baseline of the previous study until the Last Visit (up to 84 months)

Study Arms (1)

Brivaracetam

EXPERIMENTAL

Brivaracetam with a maximum of 200 mg/day

Drug: Brivaracetam

Interventions

Brivaracetam DRUG

Tablet, Flexible dosing up to 200 mg/day, twice daily. The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.

Also known as: UCB34714

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:

• Subject completed the Treatment Period of N01358 or the evaluation period of N01258
• Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted
• Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected
• Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible

You may not qualify if:

• Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies
• Severe medical, neurological, or 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 BRV study
• Planned participation in any other clinical study of another investigational drug or device during this study
• Pregnant or lactating woman
• Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months

Sponsors & Collaborators

• UCB BIOSCIENCES, Inc.: lead

Study Sites (184)

001

Phoenix, Arizona, 85004, United States

Location

013

Phoenix, Arizona, 85006, United States

Location

006

Tucson, Arizona, 85718, United States

Location

775

Little Rock, Arkansas, 72205, United States

Location

025

San Francisco, California, 94115, United States

Location

060

Aurora, Colorado, 80045, United States

Location

071

Miami, Florida, 33176, United States

Location

027

Orlando, Florida, 32819, United States

Location

064

Port Charlotte, Florida, 33952, United States

Location

023

Atlanta, Georgia, 30322, United States

Location

048

Rome, Georgia, 30165, United States

Location

039

Boise, Idaho, 83702, United States

Location

029

Chicago, Illinois, 60612, United States

Location

005

Peoria, Illinois, 61637, United States

Location

017

Winfield, Illinois, 60190, United States

Location

020

Ames, Iowa, 50010, United States

Location

069

Iowa City, Iowa, 52242, United States

Location

780

Lexington, Kentucky, 40536, United States

Location

008

Bethesda, Maryland, 20817, United States

Location

068

Waldorf, Maryland, 20603, United States

Location

009

Golden Valley, Minnesota, 55422, United States

Location

032

Lebanon, New Hampshire, 03756, United States

Location

042

Hamilton, New Jersey, 08619, United States

Location

099

New York, New York, 10011, United States

Location

022

New York, New York, 10016, United States

Location

098

Poughkeepsie, New York, 12601, United States

Location

010

Asheville, North Carolina, 28806, United States

Location

003

Durham, North Carolina, 27705, United States

Location

034

Cleveland, Ohio, 44195, United States

Location

778

Columbus, Ohio, 43210, United States

Location

070

Columbus, Ohio, 43215, United States

Location

002

Toledo, Ohio, 43614, United States

Location

043

Oklahoma City, Oklahoma, 73112, United States

Location

091

Oklahoma City, Oklahoma, 73112, United States

Location

054

Tulsa, Oklahoma, 74136-83, United States

Location

015

Philadelphia, Pennsylvania, 19107, United States

Location

028

Charleston, South Carolina, 29425, United States

Location

021

Port Royal, South Carolina, 29965, United States

Location

776

Nashville, Tennessee, 37232-25, United States

Location

061

Austin, Texas, 78758, United States

Location

011

Dallas, Texas, 75251, United States

Location

777

Dallas, Texas, 75251, United States

Location

035

Dallas, Texas, 75390, United States

Location

049

Houston, Texas, 77025, United States

Location

050

Mansfield, Texas, 76063, United States

Location

036

Charlottesville, Virginia, 22908, United States

Location

056

Spokane, Washington, 99204, United States

Location

052

Madison, Wisconsin, 53715, United States

Location

057

Milwaukee, Wisconsin, 53215, United States

Location

202

Innsbruck, Austria

Location

201

Linz, Austria

Location

203

Vienna, Austria

Location

226

Hechtel-Eksel, Belgium

Location

227

Leuven, Belgium

Location

104

Belo Horizonte, Brazil

Location

100

Florianópolis, Brazil

Location

101

São Paulo, Brazil

Location

294

Blagoevgrad, Bulgaria

Location

286

Sofia, Bulgaria

Location

287

Sofia, Bulgaria

Location

075

Calgary, Alberta, Canada

Location

078

London, Ontario, Canada

Location

076

Toronto, Ontario, Canada

Location

077

Greenfield Park, Quebec, Canada

Location

080

Saskatoon, Saskatchewan, Canada

Location

079

Montreal, Canada

Location

917

Brno, Czechia

Location

916

Kroměříž, Czechia

Location

251

Ostrava, Czechia

Location

256

Ostrava, Czechia

Location

913

Ostrava Poruba, Czechia

Location

252

Prague, Czechia

Location

253

Prague, Czechia

Location

250

Zlín, Czechia

Location

650

Tallinn, Estonia

Location

652

Tallinn, Estonia

Location

651

Tartu, Estonia

Location

275

Kuopio, Finland

Location

276

Tampere, Finland

Location

301

Béthune, France

Location

305

Montpellier, France

Location

329

Berlin, Germany

Location

326

Bernau, Germany

Location

332

Bielefeld, Germany

Location

902

Erlangen, Germany

Location

331

Göttingen, Germany

Location

327

Kiel, Germany

Location

900

Marburg, Germany

Location

335

München, Germany

Location

334

Osnabrück, Germany

Location

330

Ravensburg, Germany

Location

328

Ulm, Germany

Location

700

Hong Kong, Hong Kong

Location

701

Hong Kong, Hong Kong

Location

410

Budapest, Hungary

Location

411

Budapest, Hungary

Location

412

Budapest, Hungary

Location

414

Hajdú-Bihar, Hungary

Location

413

Szekszárd, Hungary

Location

731

Nashik, Maharashtra, India

Location

726

Bangalore, India

Location

727

Hyderabad, India

Location

729

Madurai, India

Location

725

Mumbai, India

Location

728

Mumbai, India

Location

378

Bari, Italy

Location

380

Florence, Italy

Location

379

Milan, Italy

Location

377

Monserrato, Italy

Location

386

Napoli, Italy

Location

376

Perugia, Italy

Location

375

Pisa, Italy

Location

383

Pozzilli, Italy

Location

384

Reggio Calabria, Italy

Location

852

Itami, Hyōgo, Japan

Location

855

Hiroshima, Japan

Location

850

Osaka, Japan

Location

851

Shizuoka, Japan

Location

854

Yokohama, Japan

Location

627

Daugavpils, Latvia

Location

629

Jēkabpils, Latvia

Location

628

Riga, Latvia

Location

625

Valmiera, Latvia

Location

425

Alytus, Lithuania

Location

427

Kaunas, Lithuania

Location

426

Vilnius, Lithuania

Location

126

Guadalajara, Jalisco, Mexico

Location

128

Guadalajara, Jalisco, Mexico

Location

129

Aguascalientes, Mexico

Location

127

Culiacán, Mexico

Location

125

Distrito Federal, Mexico

Location

130

Mexico City, Mexico

Location

401

Heemstede, Netherlands

Location

400

Heeze, Netherlands

Location

403

Zwolle, Netherlands

Location

475

Bialystok, Poland

Location

485

Gdansk, Poland

Location

791

Gdansk, Poland

Location

478

Katowice, Poland

Location

480

Katowice, Poland

Location

481

Katowice, Poland

Location

795

Katowice, Poland

Location

476

Krakow, Poland

Location

793

Krakow, Poland

Location

483

Lublin, Poland

Location

477

Poznan, Poland

Location

479

Poznan, Poland

Location

482

Poznan, Poland

Location

488

Warsaw, Poland

Location

794

Warsaw, Poland

Location

038

San Juan, Puerto Rico

Location

501

Kazan', Russia

Location

506

Kazan', Russia

Location

502

Moscow, Russia

Location

503

Moscow, Russia

Location

509

Nizhny Novgorod, Russia

Location

508

Smolensk, Russia

Location

753

Busan, South Korea

Location

750

Seoul, South Korea

Location

751

Seoul, South Korea

Location

754

Seoul, South Korea

Location

528

Barcelona, Spain

Location

529

Barcelona, Spain

Location

535

Barcelona, Spain

Location

540

Barcelona, Spain

Location

539

Donostia / San Sebastian, Spain

Location

532

Santiago de Compostela, Spain

Location

527

Valencia, Spain

Location

537

Valencia, Spain

Location

526

Valladolid, Spain

Location

551

Gothenburg, Sweden

Location

552

Linköping, Sweden

Location

550

Stockholm, Sweden

Location

806

Kaohsiung City, Taiwan

Location

801

Taichung, Taiwan

Location

800

Tainan, Taiwan

Location

803

Taoyuan District, Taiwan

Location

602

Morriston, Swansea, United Kingdom

Location

603

Birmingham, United Kingdom

Location

600

London, United Kingdom

Location

605

Middlesbrough, United Kingdom

Location

607

Newcastle, United Kingdom

Location

608

Salford, United Kingdom

Location

601

Truro, United Kingdom

Location

Related Publications (4)

• 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

• Brandt C, Dimova S, Elmoufti S, Laloyaux C, Nondonfaz X, Klein P. Retention, efficacy, tolerability, and quality of life during long-term adjunctive brivaracetam treatment by number of lifetime antiseizure medications: A post hoc analysis of phase 3 trials in adults with focal seizures. Epilepsy Behav. 2023 Jan;138:108967. doi: 10.1016/j.yebeh.2022.108967. Epub 2022 Nov 23.

  PMID: 36435010 DERIVED

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

  PMID: 26899665 DERIVED

• Klein P, Schiemann J, Sperling MR, Whitesides J, Liang W, Stalvey T, Brandt C, Kwan P. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015 Dec;56(12):1890-8. doi: 10.1111/epi.13212. Epub 2015 Oct 16.

  PMID: 26471380 DERIVED

Related Links

• Product Information
• FDA Safety Alerts and Recalls

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: April 19, 2011
• First Posted: April 20, 2011
• Study Start: May 11, 2011
• Primary Completion: April 18, 2019
• Study Completion: April 18, 2019
• Last Updated: August 17, 2021
• Results First Posted: June 4, 2020

Record last verified: 2021-08

Locations

HU (5); HK (2); IN (6); BE (2); BU (3); NL (3); RU (6); TW (4); DE (11); FI (2); JP (5); KR (4); IT (9); PL (15); US (49); LA (4); LI (3); PR (1); FR (2); SE (3); BR (3); GB (7); CA (6); ES (9); CZ (8); AU (3); ME (6)