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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00761774
First received: September 26, 2008
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: Brivaracetam
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 7 years) [ Time Frame: During the Evaluation Period (up to 7 years) ] [ Designated as safety issue: No ]
    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.

  • Withdrawal due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 7 years) [ Time Frame: During the Evaluation Period (up to 7 years) ] [ Designated as safety issue: No ]
    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.

  • Occurrence of a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 7 years) [ Time Frame: During the Evaluation Period (up to 7 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects on continuous Brivaracetam monotherapy for at least 3 months of the Evaluation Period (up to 7 years) [ Time Frame: During the Evaluation Period (up to 7 years) ] [ Designated as safety issue: No ]
  • Percentage of subjects on continuous Brivaracetam monotherapy for at least 6 months, of the Evaluation Period (up to 7 years) [ Time Frame: During the Evaluation Period (up to 7 years) ] [ Designated as safety issue: No ]
  • Percentage of subjects on continuous Brivaracetam monotherapy for at least 12 months of the Evaluation Period (up to 7 years) [ Time Frame: During the Evaluation Period (up to 7 years) ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: November 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brivaracetam
Brivaracetam at flexible dosing up to 200mg /day
Drug: Brivaracetam
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.
Other Name: ucb 34714

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

• 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761774

  Show 57 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00761774     History of Changes
Other Study ID Numbers: N01315, 2008-001433-98
Study First Received: September 26, 2008
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Ministry of Social Affairs, Public Health and the Environment
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Finland: Finnish Medicines Agency
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Spain: Ministry of Health

Keywords provided by UCB, Inc.:
Epilepsy
Monotherapy
Partial Onset Seizures

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 26, 2014