A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures. - Full Text View

Purpose

This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.

Condition	Intervention	Phase
Epilepsy	Other: Placebo Drug: Brivaracetam Drug: Brivaracetam 20 mg/day	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-blind, Randomized, Placebo-controlled, Dose-ranging Trial Evaluating the Efficacy and Safety of Brivaracetam as Adjunctive Treatment at Doses of 5, 20 and 50 mg/Day in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures.

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Brivaracetam

U.S. FDA Resources

Further study details as provided by UCB Pharma:

Primary Outcome Measures:

Partial onset seizure frequency (Type 1) per week over the 7-week Treatment Period [ Time Frame: Baseline to 7-week Treatment Period ] [ Designated as safety issue: No ]
Partial onset seizure frequency (Type 1) per week over the 7-week Treatment Period

Secondary Outcome Measures:

Percent change from Baseline to the 7-week Treatment Period in seizure frequency per week for partial onset seizures (Type 1) [ Time Frame: Baseline to the 7-week Treatment Period ] [ Designated as safety issue: No ]
Percent change from Baseline to the 7-week Treatment Period in seizure frequency per week for partial onset seizures (Type 1)
50 percent responder rate in partial onset seizures (Type I) frequency over the 7-week Treatment Period [ Time Frame: 7-week Treatment Period ] [ Designated as safety issue: No ]
50 percent responder rate in partial onset seizures (Type I) frequency over the 7-week Treatment Period
Percentage of seizure-free subjects (all seizure types) over the 7-week treatment period. [ Time Frame: 7-week Treatment Period ] [ Designated as safety issue: No ]
Percentage of seizure-free subjects (all seizure types) over the 7-week treatment period.


Enrollment:	210
Study Start Date:	November 2005
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Matching Placebo tablets administered twice a day	Other: Placebo Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period
Experimental: Brivaracetam 5 mg/day Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Drug: Brivaracetam Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 5 mg/day in a double-blinded way for the 7-week Treatment period
Experimental: Brivaracetam 20 mg/day Brivaracetam 20 mg/day, 10 mg administered twice a day	Drug: Brivaracetam 20 mg/day Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg/day in a double-blinded way for the 7-week Treatment period
Experimental: Brivaracetam 50 mg/day Brivaracetam 50 mg/day, 25 mg administered twice a day	Drug: Brivaracetam Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg/day in a double-blinded way for the 7-week Treatment period

Eligibility


Ages Eligible for Study:	16 Years to 65 Years (Child, Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male/female from 16 to 65 years.
Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification.
History of partial onset seizures.
Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1.
Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.

Exclusion Criteria:

Seizure type IA non-motor as only seizure type.
Seizures occurring only in clusters.
Status epilepticus during the last 2 years before Visit 1.
History of cerebrovascular accident (CVA).
Presence of any sign suggesting rapidly progressing brain disorder or brain tumor.

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: NCT00175825

Show 42 Study Locations

Sponsors and Collaborators

UCB Pharma

Investigators


Study Director:	UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)

More Information


Responsible Party:	Study Director, UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00175825 History of Changes
Other Study ID Numbers:	N01193
Study First Received:	September 9, 2005
Last Updated:	August 28, 2012
Health Authority:	United States: Food and Drug Administration Brazil: National Health Surveillance Agency Mexico: Ministry of Health India: Ministry of Health

Keywords provided by UCB Pharma:


Epilepsy: partial onset seizures brivaracetam

Additional relevant MeSH terms:


Epilepsy Seizures Brain Diseases Central Nervous System Diseases	Nervous System Diseases Neurologic Manifestations Signs and Symptoms

ClinicalTrials.gov processed this record on September 23, 2016