An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761774
• Other study ID #: N01315
• Secondary ID: 2008-001433-98
• Status: Completed
• Phase: Phase 3
• Start date: November 2008
• Est. completion date: March 2017

Study information

• Verified date: March 2018
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16 years and older with epilepsy. This study permits continued access to treatment for subjects who participated in a previous epilepsy study. The study will explore the long-term safety and efficacy of brivaracetam.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Subjects with epilepsy who participated in previous brivaracetam trials which allow access to the present trial.

• Subjects from whom the Investigator believes a reasonable potential benefit from the long-term administration of brivaracetam may be expected.

Exclusion Criteria:

• Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behaviour, or laboratory values which may have an impact on the safety of the subject, as determined by the investigator.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Brivaracetam
Subjects will begin at a recommended dose of Brivaracetam 100 mg/day. Subjects will continue treatment at a dose up to a maximum of 200 mg/day with a twice per day administration. Up- and down-titration steps may be performed in steps of a maximum of 50 mg/day on a weekly basis. Full down-titration should include a one week step on 20 mg/day. The study medication will come in 10 mg and 25 mg tablet strengths.

Locations

Country	Name	City	State
Australia	404	Adelaide	South Australia
Australia	400	Chatswood	New South Wales
Australia	402	Fitzroy	Victoria
Australia	401	Parkville	Victoria
Belgium	004	Gent
Belgium	003	Kortrijk
Canada	205	Calgary	Alberta
Canada	203	Edmonton	Alberta
Canada	206	Toronto	Ontario
Czechia	023	Brno
Czechia	020	Litomysl
Czechia	021	Ostava
Czechia	024	Ostrava-Trebovice
Czechia	026	Praha 4
France	040	Bethune
France	041	Toulouse Cedex 09
Germany	055	Berlin
Germany	056	Bernau
Germany	054	Bielefeld
Germany	063	Mainz
Germany	051	Munchen
Germany	065	Regensburg
Hungary	072	Budapest
Hungary	074	Budapest
Italy	084	Bergamo
Italy	082	Messina
Italy	085	Orbassano
Italy	083	Perugia
Italy	080	Pisa
Spain	090	Madrid
Sweden	100	Goteborg
Sweden	102	Lund
Sweden	101	Stockholm
United States	260	Austin	Texas
United States	236	Bedford	Texas
United States	218	Burlington	Vermont
United States	278	Burlington	Massachusetts
United States	277	Charleston	West Virginia
United States	241	Columbus	Ohio
United States	267	Dallas	Texas
United States	279	Danville	Virginia
United States	281	Fresno	California
United States	297	Germantown	Tennessee
United States	284	Hickory	North Carolina
United States	268	Houston	Texas
United States	224	Indianapolis	Indiana
United States	211	Layton	Utah
United States	266	Lexington	Kentucky
United States	213	Marshfield	Wisconsin
United States	270	New York	New York
United States	235	Ogden	Utah
United States	265	Oklahoma City	Oklahoma
United States	288	Pasadena	California
United States	285	Peoria	Illinois
United States	304	Phoenix	Arizona
United States	240	Riverside	California
United States	245	Sacramento	California
United States	231	Waldorf	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  France,  Germany,  Hungary,  Italy,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)	Treatment-emergent Adverse events (TEAE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.	During the Evaluation Period (up to 9 years)
Primary	Percentage of Subjects Who Withdrew Due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)	Adverse Events (AE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.	During the Evaluation Period (up to 9 years)
Primary	Percentage of Subjects With a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)	An SAE was any untoward medical occurrence that, at any dose resulted in death, was life threatening, required in-subject hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.	During the Evaluation Period (up to 9 years)
Secondary	Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 3 Months of the Evaluation Period (up to 9 Years)	BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.	During the Evaluation Period (up to 9 years)
Secondary	Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 6 Months, of the Evaluation Period (up to 9 Years)	BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.	During the Evaluation Period (up to 9 years)
Secondary	Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 12 Months of the Evaluation Period (up to 9 Years)	BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.	During the Evaluation Period (up to 9 years)

External Links

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