CompletedPhase 2

Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

United States39 participantsStarted 2010-08

Plain-language summary

The purpose is to obtain data on the safety and seizure frequency associated with long-term oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed SP0961 (NCT01118949) to continue to receive Lacosamide.

Who can participate

Age range16 Years – 65 Years

SexALL

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Inclusion Criteria: * Subject completed the SP0961 (NCT01118949) study * Subject is expected to benefit from participation in an open-label extension study with Lacosamide, in the opinion of the investigator Exclusion Criteria: * Subject meets the withdrawal criteria for SP0961 (NCT01118949) or is experiencing an ongoing Serious Adverse Event (SAE)

What they're measuring

Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)

Timeframe: From Visit 1 to the end of study (Approximately 61 weeks)

Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)

Timeframe: From Visit 1 to the end of study (Approximately 61 weeks)

Trial details

NCT IDNCT01118962

SponsorUCB BIOSCIENCES, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-10

Results submitted2013-10-07

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