Not Signed In -
Epilepsy |
Seizure Disorders |
Clinical Trial: A Long Term Follow-Up Trial to Evaluate the Safety and Efficacy of Brivaracetam in Subjects Aged 16 Years or Older Suffering from Partial Onset Seizures.
This study is not yet open for patient recruitment.
Verified by UCB Pharma September 2005
|
Purpose
This trial, evaluating the long-term safety and tolerability of brivaracetam and the maintenance of efficacy over time, will give subjects suffering from partial onset seizures, who may have benefited from brivaracetam the opportunity to continue the treatment.
| Condition | Intervention | Phase |
|---|---|---|
| Epilepsy | Drug: Brivaracetam (ucb 34714) | Phase III |
MedlinePlus related topics: Epilepsy
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title: An Open-Label, Multicenter, Follow-Up Trial to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose Up to a Maximum of 100 Mg/Day in Subjects Aged 16 Years or Older Suffering from Partial Onset Seizures.
Further Study Details:
Primary Outcomes: To evaluate the long-term safety and tolerability of brivaracetam at individualized doses with a maximum of 100 mg/day in subjects suffering from partial onset seizures.
Secondary Outcomes: To evaluate the maintenance of efficacy over time of brivaracetam based on seizure frequency.
Expected Total Enrollment: 200
Secondary Outcomes: To evaluate the maintenance of efficacy over time of brivaracetam based on seizure frequency.
Expected Total Enrollment: 200
Study start: December 2005
Eligibility
Ages Eligible for Study: 16 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Male/female subjects from 16 years or older.
- Subjects with partial onset seizures who were treated with brivaracetam in previous trials which allow access to the present trial.
- Subjects from whom the investigator believes a reasonable benefit from the long-term administration of brivaracetam may be expected.
Exclusion Criteria:
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Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00150800
UCB - Clinical Trial Call Center +1 877 822 9493
Study chairs or principal investigators
Philipp von Rosenstiel, M.D., Study Director, UCB Pharma, Inc.
More Information
Study ID Numbers: N01199
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150800
Health Authority: United States: Food and Drug Administration; Brazil: Committee of Ethics in Research; Mexico: National Institute of Public Health, Health Secretariat; India: India''''s Drug Controller General, a division of the Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150800
Health Authority: United States: Food and Drug Administration; Brazil: Committee of Ethics in Research; Mexico: National Institute of Public Health, Health Secretariat; India: India''''s Drug Controller General, a division of the Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- (National Women's Health Information Center, OWH, HHS)
- A Pacemaker for the Brain (Cleveland Clinic)
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