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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00761774
First Posted: September 30, 2008
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
  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: Intervention Model: Single Group Assignment
Masking: None (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 Pharma:

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 9 years) [ Time Frame: During the Evaluation Period (up to 9 years) ]
    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 9 years) [ Time Frame: During the Evaluation Period (up to 9 years) ]
    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 9 years) [ Time Frame: During the Evaluation Period (up to 9 years) ]

Secondary Outcome Measures:
  • Percentage of subjects on continuous Brivaracetam monotherapy for at least 3 months of the Evaluation Period (up to 9 years) [ Time Frame: During the Evaluation Period (up to 9 years) ]
  • Percentage of subjects on continuous Brivaracetam monotherapy for at least 6 months, of the Evaluation Period (up to 9 years) [ Time Frame: During the Evaluation Period (up to 9 years) ]
  • Percentage of subjects on continuous Brivaracetam monotherapy for at least 12 months of the Evaluation Period (up to 9 years) [ Time Frame: During the Evaluation Period (up to 9 years) ]

Enrollment: 108
Study Start Date: November 2008
Study Completion Date: March 2017
Primary Completion Date: March 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761774


  Show 58 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Cares +1 844 599 2273(UCB)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00761774     History of Changes
Other Study ID Numbers: N01315
2008-001433-98 ( EudraCT Number )
First Submitted: September 26, 2008
First Posted: September 30, 2008
Last Update Posted: April 13, 2017
Last Verified: April 2017

Keywords provided by UCB Pharma:
Epilepsy
Monotherapy
Partial Onset Seizures

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