This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment

Phase 3

Completed

• Conditions: Epilepsy
• Interventions: Drug: Brivaracetam

• Registration Number: NCT00150800
• Lead Sponsor: UCB PHARMA Inc. (US)

Brief Summary

This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.

Detailed Description

Study access was limited to subjects having completed one of the previous brivaracetam (BRV) studies: N01193 \[NCT00175825\], N01252 \[NCT00490035\], N01253 \[NCT00464269\], N01254 \[NCT00504881\].

Study Timeline

• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Study Start: 2006-01
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Results First Submitted: 2018-09-18
• Results First Submitted QC: 2018-11-09
• Results First Posted: 2018-12-05
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 668

Inclusion Criteria

• Male/ female subjects from 16 years and on. Subjects under 18 years may only be included where legally permitted and ethically accepted
• Subjects with epilepsy who have participated in previous brivaracetam trials which allow access to the present study
• Subjects for whom the investigator believes a reasonable benefit from the long term administration of brivaracetam may be expected
• Female subjects without childbearing potential. Female subjects with child bearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study
• Subject/ legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator

Exclusion Criteria

• Severe medical, neurological and psychiatric disorders or laboratory values which may have an impact on the safety of the subject
• Poor compliance with the visit schedule or medication intake in the previous brivaracetam study
• Pregnant or lactating women
• Participation in any clinical study of another investigational drug or device during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brivaracetam	Brivaracetam	Brivaracetam used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg/day on a weekly basis.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period	Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)	Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period	Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)	Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period	Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)	A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.

Secondary Outcome Measures

Name	Time	Method
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period	From Baseline of the previous study to the Evaluation Period (up to 11 years)	Baseline is the Baseline from subject's previous study of enrollment period. N01193 \[NCT00175825\], N01252 \[NCT00490035\], N01253 \[NCT00464269\], N01254 \[NCT00504881\].; A 28 day Type 1 seizure frequency is the total number of Type 1 seizures divided by the total number of days evaluated multiplied by 28.
Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period	From Baseline of the previous study to the Evaluation Period (up to 11 years)	A responder is defined as a subject with a higher than or equal to (\>=) 50 % change in seizure frequency from Baseline period of the previous study.
Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period	From Baseline of the previous study to the Evaluation Period (up to 11 years)	The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as: (the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines.

Trial Locations

Locations (100)

N01199 1051; 🇺🇸 Phoenix, Arizona, United States

N01199 1362; 🇺🇸 Phoenix, Arizona, United States

N01199 1374; 🇺🇸 Tucson, Arizona, United States

N01199 1050; 🇺🇸 Little Rock, Arkansas, United States

N01199 1078; 🇺🇸 Fresno, California, United States

N01199 1392; 🇺🇸 Newport Beach, California, United States

N01199 1087; 🇺🇸 San Francisco, California, United States

N01199 1368; 🇺🇸 San Francisco, California, United States

N01199 1396; 🇺🇸 Atlanta, Georgia, United States

N01199 1385; 🇺🇸 Augusta, Georgia, United States

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