An Open-Label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00761774

Purpose

The Sponsor wishes to develop brivaracetam as a monotherapy antiepileptic treatment in subjects 16 years and older suffering from epilepsy. This N01315 study will give subjects, who have participated in a previous brivaracetam monotherapy study in epilepsy, the opportunity to continue brivaracetam treatment under the present protocol.

The study will explore the long-term safety and efficacy of brivaracetam in such a population and potentially populations from other future studies.

Condition	Intervention	Phase
Epilepsy	Drug: Brivaracetam	Phase III

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

MedlinePlus related topics: Epilepsy Seizures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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 150 mg/Day, in Subjects Aged 16 Years or Older Suffering From Epilepsy.

Further study details as provided by UCB:

Primary Outcome Measures:

The percent (%) reduction from baseline for seizure frequency per week for POS (type I) over the Evaluation Period (V1 until the last evaluation visit). [ Time Frame: Approximately 4 years or until market approval in the US. ] [ Designated as safety issue: No ]
The percent (%) reduction from baseline for seizure frequency per week for all epileptic seizures (types I+II+III) over the Evaluation Period. [ Time Frame: Approximately 4 years or until market approval in the US. ] [ Designated as safety issue: No ]
The safety variables studied will be adverse event reporting, laboratory testing, ECG, physical and neurological examination and plasma concentration of brivaracetam and concomitant AEDs. [ Time Frame: Approximately 4 years or until market approval in the US. ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	November 2008
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Brivaracetam Subjects will begin at a recommended dose of BRV 100 mg/day. Subjects will continue BRV treatment at a dose up to a maximum of 150 mg/day in b.i.d. administration. Up- and down-titration steps should be performed in steps of maximum 50 mg/d on a weekly basis. Full down-titration should include a one week step on 20 mg/d. The study medication will come in 10mg and 25mg tablet strengths.

Arms

Assigned Interventions

1: Experimental

Drug: Brivaracetam

Subjects will begin at a recommended dose of BRV 100 mg/day. Subjects will continue BRV treatment at a dose up to a maximum of 150 mg/day in b.i.d. administration. Up- and down-titration steps should be performed in steps of maximum 50 mg/d on a weekly basis. Full down-titration should include a one week step on 20 mg/d. The study medication will come in 10mg and 25mg tablet strengths.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761774

Show 25 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	N01315, RPCE08C0502
Study First Received:	September 26, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00761774
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Ministry of Social Affairs, Public Health and the Environment; Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Sweden: Medical Products Agency; France: Afssaps - French Health Products Safety Agency; Finland: National Agency for Medicines; Hungary: National Institute of Pharmacy; Italy: Ministry of Health; Spain: Ministry of Health

Keywords provided by UCB:

Epilepsy
Monotherapy
Partial Onset Seizures
Adults and Adolescents

Study placed in the following topic categories:

Epilepsy
Seizures
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009