Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy

NCT00504881 | Completed Phase 3 Results

• 2 other identifiers: N012542006-006346-34
• Study Type: interventional
• Target: 480
• Locations: 15 countries
• Sites: 61

Brief Summary

This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy.

Conditions

Epilepsy

Keywords

Epilepsy; Brivaracetam; Partial Onset Seizures

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period

  An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  Week 2 to the end of the Treatment Period (Week 16)

• Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period

  Partial (Type I) seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to generalized tonic-clonic convulsions. Partial Onset Seizure (POS) frequency per week over the Treatment Period (TP) was calculated as: (Total Type I seizures over the TP)\*7/(Total number of days with no missing seizure count in the TP)

  Baseline (Week 0) to the end of the Treatment Period (Week 16)

Secondary Outcomes (21)

• Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period

  Baseline (Week 0) to the end of Treatment Period (Week 16)

• Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period

  Baseline (Week 0) to the end of Treatment Period (Week 16)

• Percent Change From Baseline to the 16-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week

  Baseline (Week 0) to end of Treatment Period (Week 16)

• Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period

  Baseline to 16-week Treatment Period

• Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period

  Baseline (Week 0) to the end of Treatment Period (Week 16)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matching Placebo tablets administered twice a day

Drug: Placebo

Brivaracetam

EXPERIMENTAL

A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day

Drug: Brivaracetam

Interventions

Placebo DRUG

Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period

Placebo

Brivaracetam DRUG

Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day, in a double-blinded way for the 16-week Treatment Period

Brivaracetam

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects were aged from 16 to 70 years, inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
• Subjects had well-characterized localization-related Epilepsy or generalized Epilepsy according to the International League Against Epilepsy (ILAE) classification
• For subjects suffering from localization-related Epilepsy: subjects had at least 2 Partial-Onset Seizures (POSs) whether or not secondarily generalized per month during the 3 months preceding Visit 1 according to the ILAE classification
• For subjects suffering from localization-related Epilepsy: subjects had at least 4 Partial-Onset Seizures (POSs) whether or not secondarily generalized during the 4-week Baseline Period according to the ILAE classification
• For subjects suffering from generalized Epilepsy: subjects had at least 2 Type II-seizure days per month during the 3 months preceding Visit 1 according to the ILAE classification
• For subjects suffering from generalized Epilepsy: subjects had at least 4 Type II-seizure days during the 4 week Baseline Period according to the ILAE classification
• Subjects were uncontrolled while treated by 1 to 3 permitted concomitant Antiepileptic Drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED

You may not qualify if:

• For subjects who suffered from localization-related Epilepsy: history or presence of Seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 2 or occurring only as Type IA non-motor
• Subjects with a history or presence of Status Epilepticus during the year preceding Visit 1 or during Baseline

Sponsors & Collaborators

• UCB Pharma SA: lead

Study Sites (61)

Unknown Facility

Graz, Austria

Location

Unknown Facility

Innsbrick, Austria

Location

Unknown Facility

Linz, Austria

Location

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Bruges, Belgium

Location

Unknown Facility

Godinne, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Montignies-sur-Sambre, Belgium

Location

Unknown Facility

Beroun, Czechia

Location

Unknown Facility

Brno, Czechia

Location

Unknown Facility

Ostrava Trebovice, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Zlín, Czechia

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Bernau, Germany

Location

Unknown Facility

Bielefeld, Germany

Location

Unknown Facility

Erlangen, Germany

Location

Unknown Facility

Göttingen, Germany

Location

Unknown Facility

Jena, Germany

Location

Unknown Facility

München, Germany

Location

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Bangalore, India

Location

Unknown Facility

Hyderabad, India

Location

Unknown Facility

Mumbai, India

Location

Unknown Facility

New Delhi, India

Location

Unknown Facility

Pune Maharashtra, India

Location

Unknown Facility

Tirupati, India

Location

Unknown Facility

Bari, Italy

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Pavia, Italy

Location

Unknown Facility

Roma, Italy

Location

Unknown Facility

Siena, Italy

Location

Unknown Facility

Bergen, Norway

Location

Unknown Facility

Fredrikstad, Norway

Location

Unknown Facility

Oslo, Norway

Location

Unknown Facility

Sandvika, Norway

Location

Unknown Facility

Trondheim, Norway

Location

Unknown Facility

Kazan', Russia

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Samara, Russia

Location

Unknown Facility

Yaroslavi, Russia

Location

Unknown Facility

Singapore, Singapore

Location

Unknown Facility

Cape Town, South Africa

Location

Unknown Facility

George, South Africa

Location

Unknown Facility

Johannesburg, South Africa

Location

Unknown Facility

Tygeberg, South Africa

Location

Unknown Facility

Gwangju, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Gothenburg, Sweden

Location

Unknown Facility

Stockholm, Sweden

Location

Unknown Facility

Umeå, Sweden

Location

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taoyuan Hsien, Taiwan

Location

Unknown Facility

Donetsk, Ukraine

Location

Unknown Facility

Kharkiv, Ukraine

Location

Unknown Facility

Kyiv, Ukraine

Location

Unknown Facility

Lviv, Ukraine

Location

Unknown Facility

Odesa, Ukraine

Location

Unknown Facility

Uzhhorod, Ukraine

Location

Related Publications (4)

• Kwan P, Trinka E, Van Paesschen W, Rektor I, Johnson ME, Lu S. Adjunctive brivaracetam for uncontrolled focal and generalized epilepsies: results of a phase III, double-blind, randomized, placebo-controlled, flexible-dose trial. Epilepsia. 2014 Jan;55(1):38-46. doi: 10.1111/epi.12391. Epub 2013 Oct 3.

  PMID: 24116853 RESULT

• Mukuria C, Young T, Keetharuth A, Borghs S, Brazier J. Sensitivity and responsiveness of the EQ-5D-3L in patients with uncontrolled focal seizures: an analysis of Phase III trials of adjunctive brivaracetam. Qual Life Res. 2017 Mar;26(3):749-759. doi: 10.1007/s11136-016-1483-3. Epub 2016 Dec 21.

  PMID: 28004320 RESULT

• 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.

  PMID: 35285519 DERIVED

• 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

MeSH Terms

Conditions

Epilepsy

Interventions

brivaracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: UCB (Study Director)
• Organization: UCB Clinical Trial Call Center

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 20, 2007
• Study Start: October 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 3, 2018
• Results First Posted: March 17, 2017

Record last verified: 2018-03

Locations

HK (1); DE (7); TW (3); RU (5); SG (1); SE (3); UA (6); CZ (5); BE (4); AU (4); IT (5); KR (2); NO (5); ZA (4); IN (6)