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

• ClinicalTrials.gov Identifier: NCT00175825
• Recruitment Status: Completed
• First Posted: September 15, 2005
• Results First Posted: August 22, 2018
• Last Update Posted: October 2, 2018
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Epilepsy	Other: Placebo; Drug: Brivaracetam	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, 4 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment at Doses of 5, 20 and 50 mg/Day in b.i.d. Administration (Oral Tablets of 2.5 or 10 mg) for a Maximum of 7 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized
• Actual Study Start Date: November 7, 2005
• Actual Primary Completion Date: June 29, 2006
• Actual Study Completion Date: June 29, 2006

Arms and Interventions

Arm	Intervention/treatment
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 over the 7-week Treatment Period; Other Name: Briviact
Experimental: Brivaracetam 20 mg/day; Brivaracetam 20 mg/day, 10 mg administered twice a day	Drug: Brivaracetam; Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period; Other Name: Briviact
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 over the 7-week Treatment Period; Other Name: Briviact

Outcome Measures

Primary Outcome Measures :

1. Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period [ Time Frame: During the 7-week Treatment Period ]
   Calculated as 7-day partial onset seizure frequency.

Secondary Outcome Measures :

1. Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period [ Time Frame: Baseline, during the 7-week Treatment Period ]
   Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.
2. Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period [ Time Frame: During the 7-week Treatment Period ]
   Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period.
3. Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period [ Time Frame: During the 7-week Treatment Period ]
   Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.
4. Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period [ Time Frame: During the 7-week Treatment Period ]
   Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.
5. Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period [ Time Frame: During the 7-week Treatment Period ]
   Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.
6. Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period [ Time Frame: During the 7-week Treatment Period ]
   A responder was defined as a subject with a >= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period.
7. Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period [ Time Frame: During the 7-week Treatment Period ]
   Categories of percentage reductions in seizures from baseline were as following: < -25 %; -25 % to <25 %; 25 % to <75 %; 75 % to <100 %; 100 %.
8. Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period [ Time Frame: During the 7-week Treatment Period ]
   A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period.
9. Number of Seizure-free Days Per 4 Weeks [ Time Frame: Baseline, during the 7-week Treatment Period ]
   A day was considered seizure-free, if no seizure was reported during 24 hours.
10. Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period [ Time Frame: During the 7-week Treatment Period ]
    Number of days to first, fifth, and tenth seizure after baseline.

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Arizona

Phoenix, Arizona, United States

United States, Arkansas

Little Rock, Arkansas, United States

United States, California

Fresno, California, United States

United States, Florida

Bradenton, Florida, United States

Jacksonville, Florida, United States

United States, Illinois

Chicago, Illinois, United States

United States, Kentucky

Paducah, Kentucky, United States

United States, Louisiana

Ruston, Louisiana, United States

United States, Maryland

Bethesda, Maryland, United States

United States, Massachusetts

Burlington, Massachusetts, United States

United States, Michigan

Grand Rapids, Michigan, United States

United States, Minnesota

Rochester, Minnesota, United States

United States, Mississippi

Tupelo, Mississippi, United States

United States, Missouri

Chesterfield, Missouri, United States

United States, Montana

Great Falls, Montana, United States

United States, New Jersey

Englewood Cliffs, New Jersey, United States

Toms River, New Jersey, United States

United States, New York

New York, New York, United States

United States, North Carolina

Wilmington, North Carolina, United States

United States, Ohio

Columbus, Ohio, United States

United States, Pennsylvania

Philadelphia, Pennsylvania, United States

United States, Rhode Island

Woonsocket, Rhode Island, United States

United States, South Carolina

Greenville, South Carolina, United States

United States, Texas

Dallas, Texas, United States

Houston, Texas, United States

United States, Utah

Salt Lake City, Utah, United States

Brazil

Florianopolis, Brazil

Salvador, Brazil

Sao Paulo, Brazil

India

Bangalore, India

Hyderabad, India

Lucknow, India

Parel Mumbai, India

Trivandrum, India

Mexico

Aguascalientes, Mexico

Chichuahua, Mexico

Chihuahua, Mexico

Guadalajara, Mexico

Monterrey, Mexico

San Luis Potosi, Mexico

Valle Oriente Garza Garcia, Mexico

Zapopan, Mexico

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Cares; +1 844 599 2273 (UCB)

More Information

Additional Information:

Product Information 

FDA Safety Alerts and Recalls 

Publications of Results:

Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. doi: 10.1111/epi.13416. Epub 2016 Jun 6.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Brandt C, Klein P, Badalamenti V, Gasalla T, Whitesides J. Safety and tolerability of adjunctive brivaracetam in epilepsy: In-depth pooled analysis. Epilepsy Behav. 2020 Feb;103(Pt A):106864. doi: 10.1016/j.yebeh.2019.106864. Epub 2020 Jan 12. Review.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00175825
• Other Study ID Numbers: N01193
• First Posted: September 15, 2005
• Results First Posted: August 22, 2018
• Last Update Posted: October 2, 2018
• Last Verified: September 2018

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; Brivaracetam; Anticonvulsants