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Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy

Primary Purpose

Epilepsy

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Brivaracetam (ucb 34714)

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Brivaracetam, Epilepsy, long term

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male/female subjects from 16 years (where legally permitted and ethically accepted) or 18 years onwards suffering from epilepsy and having completed a previous study with brivaracetam as adjunctive treatment, which allowed access to this study Subjects with POS/PGS: inpatients or outpatients with epilepsy who participated in previous brivaracetam studies / programs which allow access to the present study Subjects with ULD: inpatients or outpatients with epilepsy who were treated with brivaracetam in previous studies / programs 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 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 visit schedule or medication intake in previous brivaracetam study Participation in any clinical study of another investigational drug or device during the study Pregnant or lactating woman

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brivaracetam

Arm Description

Flexible dosing, can up and down titrate as needed.

Outcomes

Primary Outcome Measures

Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)

Treatment-emergent adverse events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.

Percentage of Participants Who Withdrew Due to an Adverse Event (AE)

An AE is any untoward medical occurrence in a participant or trial participant that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

Percentage of Participants With at Least One Serious Adverse Event (SAE)

A serious adverse event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect Is an infection that requires treatment parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.

Secondary Outcome Measures

Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period

The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28. Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 [NCT00175929], N01252 [NCT00490035] and N01254 [NCT00504881].

Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period

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. Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 [NCT00175929], N01252 [NCT00490035] and N01254 [NCT00504881].

Responder Rate in POS (Type I) Frequency Over the Evaluation Period

A responder is defined as a participant with a ≥ 50% reduction in seizure frequency from the Baseline Period of the previous study. Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 [NCT00175929], N01252 [NCT00490035] and N01254 [NCT00504881].

Full Information

NCT ID

NCT00175916

First Posted

September 9, 2005

Last Updated

August 16, 2021

Sponsor

UCB Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00175916

Brief Title

Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy

Official Title

An Open-label, Multicenter, Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

September 2005 (Actual)

Primary Completion Date

May 2019 (Actual)

Study Completion Date

May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UCB Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial, evaluating the long-term safety and tolerability of brivaracetam, will give subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity to continue the treatment. The study will also evaluate the maintenance of efficacy over time of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures (PGS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

Keywords

Brivaracetam, Epilepsy, long term

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

853 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brivaracetam

Arm Type

Experimental

Arm Description

Flexible dosing, can up and down titrate as needed.

Intervention Type

Drug

Intervention Name(s)

Brivaracetam (ucb 34714)

Intervention Description

10 mg and 25 mg tablets. Flexible dosing up to 200 mg/day, twice daily. For each subject, the study will last from study entry until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures; or until the Sponsor decides to close the study; until a managed access program, named patient program, compassionate use program, or similar type of access program is established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development is stopped by the Sponsor.

Primary Outcome Measure Information:

Title

Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)

Description

Time Frame