Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy

NCT00175916 | Completed Phase 3 Results

• 2 other identifiers: N011252004-002140-10
• Study Type: interventional
• Target: 853
• Locations: 25 countries
• Sites: 150

Brief Summary

This trial, evaluating the long-term safety and tolerability of brivaracetam, will give subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity to continue the treatment. The study will also evaluate the maintenance of efficacy over time of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures (PGS).

Conditions

Epilepsy

Keywords

Brivaracetam; Epilepsy; long term

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 until Last Visit (up to 162 months)

• Percentage of Participants Who Withdrew Due to an Adverse Event (AE)

  An AE is any untoward medical occurrence in a participant or trial participant 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 until Last Visit (up to 162 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 an 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 until Last Visit (up to 162 months)

Secondary Outcomes (3)

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

  From Entry Visit until Last Visit (up to 162 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 Entry Visit until Last Visit (up to 162 months)

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

  From Entry Visit until Last Visit (up to 162 months)

Study Arms (1)

Brivaracetam

EXPERIMENTAL

Flexible dosing, can up and down titrate as needed.

Drug: Brivaracetam (ucb 34714)

Interventions

Brivaracetam (ucb 34714) DRUG

10 mg and 25 mg tablets. Flexible dosing up to 200 mg/day, twice daily. For each subject, the study will last from study entry 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; until a managed access program, named patient program, compassionate use program, or similar type of access program is established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development is stopped by the Sponsor.

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 (where legally permitted and ethically accepted) or 18 years onwards suffering from epilepsy and having completed a previous study with brivaracetam as adjunctive treatment, which allowed access to this study
• Subjects with POS/PGS: inpatients or outpatients with epilepsy who participated in previous brivaracetam studies / programs which allow access to the present study
• Subjects with ULD: inpatients or outpatients with epilepsy who were treated with brivaracetam in previous studies / programs 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

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 visit schedule or medication intake in previous brivaracetam study
• Participation in any clinical study of another investigational drug or device during the study
• Pregnant or lactating woman

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (153)

935

San Francisco, California, 94115, United States

Location

933

Gainesville, Florida, 32610, United States

Location

931

Charlottesville, Virginia, 22908, United States

Location

509

Graz, Austria

Location

507

Innsbruck, Austria

Location

510

Linz, Austria

Location

508

Vienna, Austria

Location

501

Edegem, Antwerpen, Belgium

Location

515

Montignies-sur-Sambre, Chaleroi, Belgium

Location

506

Bruges, Belgium

Location

513

Ghent, Belgium

Location

974

La Louvière, Belgium

Location

505

Leuven, Belgium

Location

951

Vancouver, British Columbia, Canada

Location

950

Montreal, Quebec, Canada

Location

952

Québec, Quebec, Canada

Location

545

Beroun, Czechia

Location

543

Brno, Czechia

Location

544

Brno, Czechia

Location

546

České Budějovice, Czechia

Location

519

Ostrava Trebovice, Czechia

Location

517

Prague, Czechia

Location

541

Prague, Czechia

Location

542

Prague, Czechia

Location

518

Zlín, Czechia

Location

900

Helsinki, Finland

Location

581

Kuopio, Finland

Location

526

Oulu, Finland

Location

582

Oulu, Finland

Location

527

Seinäjoki, Finland

Location

583

Tampere, Finland

Location

811

Tampere, Finland

Location

633

Lyon, Bron, France

Location

632

Angers, France

Location

628

Béthune, France

Location

630

Dijon, France

Location

624

Lille, France

Location

625

Marseille, France

Location

623

Montpellier, France

Location

635

Nancy, France

Location

626

Paris, France

Location

920

Paris, France

Location

622

Rennes, France

Location

528

Roanne, France

Location

823

Saint-Pierre-des-Corps, France

Location

627

Strasbourg, France

Location

634

Toulouse, France

Location

532

Bad Berka, Germany

Location

705

Berlin, Germany

Location

708

Berlin, Germany

Location

536

Bernau, Germany

Location

707

Bielefeld, Germany

Location

701

Bonn, Germany

Location

709

Erlangen, Germany

Location

703

Frankfurt, Germany

Location

711

Freiburg im Breisgau, Germany

Location

537

Göttingen, Germany

Location

535

Jena, Germany

Location

710

Kehl, Germany

Location

531

Liegau-Augustusbad, Germany

Location

533

Mainz, Germany

Location

560

München, Germany

Location

706

München, Germany

Location

704

Ulm, Germany

Location

649

Hong Kong, Hong Kong

Location

650

Shatin, Hong Kong

Location

547

Budapest, Hungary

Location

538

Debrecen, Hungary

Location

539

Pécs, Hungary

Location

970

Tel Aviv, Israel

Location

830

Bologna, Italy

Location

553

Foggia, Italy

Location

831

Messina, Italy

Location

563

Milan, Italy

Location

832

Milan, Italy

Location

833

Napoli, Italy

Location

554

Pavia, Italy

Location

550

Perugia, Italy

Location

552

Roma, Italy

Location

555

Roma, Italy

Location

559

Roma, Italy

Location

973

Siena, Italy

Location

566

Breda, Netherlands

Location

821

Heemstede, Netherlands

Location

822

Heeze, Netherlands

Location

567

The Hague, Netherlands

Location

571

Fredrikstad, Norway

Location

568

Oslo, Norway

Location

569

Sandvika, Norway

Location

570

Trondheim, Norway

Location

575

Bialystok, Poland

Location

741

Gdansk, Poland

Location

978

Grodzisk Mazowiecki, Poland

Location

748

Katowice, Poland

Location

976

Katowice, Poland

Location

574

Kielce, Poland

Location

975

Krakow, Poland

Location

744

Lodz, Poland

Location

747

Lodz, Poland

Location

742

Lublin, Poland

Location

977

Poznan, Poland

Location

746

Szczecin, Poland

Location

573

Warsaw, Poland

Location

576

Warsaw, Poland

Location

577

Warsaw, Poland

Location

743

Warsaw, Poland

Location

745

Warsaw, Poland

Location

591

Kazan', Russia

Location

578

Moscow, Russia

Location

579

Moscow, Russia

Location

584

Moscow, Russia

Location

586

Moscow, Russia

Location

588

Moscow, Russia

Location

589

Saint Petersburg, Russia

Location

943

Samara, Russia

Location

587

Yaroslavl, Russia

Location

961

Belgrade, Serbia

Location

962

Belgrade, Serbia

Location

657

Singapore, Singapore

Location

648

George, South Africa

Location

655

Gwangju, South Korea

Location

652

Seoul, South Korea

Location

653

Seoul, South Korea

Location

654

Seoul, South Korea

Location

656

Seoul, South Korea

Location

599

Alcorcón, Madrid, Spain

Location

593

Barcelona, Spain

Location

596

Donostia / San Sebastian, Spain

Location

594

Madrid, Spain

Location

783

Madrid, Spain

Location

786

Madrid, Spain

Location

595

Vigo, Spain

Location

597

Zaragoza, Spain

Location

850

Gothenburg, Sweden

Location

601

Stockholm, Sweden

Location

604

Umeå, Sweden

Location

605

Biel, Switzerland

Location

607

Sankt Gallen, Switzerland

Location

606

Tschugg, Switzerland

Location

608

Zurich, Switzerland

Location

671

Taichung, Taiwan

Location

672

Taichung, Taiwan

Location

669

Tainan, Taiwan

Location

660

Taoyuan District, Taiwan

Location

861

Manouba, Tunisia

Location

860

Tunis, Tunisia

Location

638

Donetsk, Ukraine

Location

637

Kharkiv, Ukraine

Location

641

Kyiv, Ukraine

Location

642

Kyiv, Ukraine

Location

639

Lviv, Ukraine

Location

643

Odesa, Ukraine

Location

640

Uzhhorod, Ukraine

Location

Related Publications (3)

• 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

• 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.

  PMID: 33461041 DERIVED

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

  PMID: 26899665 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: September 9, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2005
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 17, 2021
• Results First Posted: July 16, 2020

Record last verified: 2021-08

Locations

SE (2); TW (4); TU (2); IL (1); UA (7); ES (8); RU (9); CA (3); DE (17); SG (1); HU (3); FI (7); US (3); FR (15); CH (4); PL (17); ZA (1); NO (4); KR (5); AU (4); HK (2); BE (6); IT (12); NL (4); CZ (9)