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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118962
• Other study ID #: SP0962
• Secondary ID: 2014-004375-23
• Status: Completed
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: October 2012

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Generalized
• Seizures

Intervention

Drug:
• Lacosamide
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). At the beginning of SP0962, the dose may be maintained, or increased or decreased by 100 mg /day, as deemed clinically appropriate to optimize tolerability and seizure reduction. Dose increases should be no faster than 100 mg/ day per week up to a maximum of 800 mg/ day. Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses for up to a 56-week Treatment Phase. The Treatment Phase was followed by a 5-week End-of-Study Phase, during which subjects had to be tapered off Lacosamide at a recommended decrease rate of 200 mg/ day per week.

Locations

Country	Name	City	State
United States	613	Atlanta	Georgia
United States	628	Aurora	Colorado
United States	609	Bethesda	Maryland
United States	617	Boise	Idaho
United States	608	Charleston	South Carolina
United States	615	Chesterfield	Missouri
United States	620	Columbus	Ohio
United States	612	Dallas	Texas
United States	614	Fort Wayne	Indiana
United States	605	Lexington	Kentucky
United States	602	Little Rock	Arkansas
United States	616	Louisville	Kentucky
United States	624	Madison	Wisconsin
United States	601	Nashville	Tennessee
United States	607	New York	New York
United States	610	Norfolk	Virginia
United States	603	Phoenix	Arizona
United States	623	Renton	Washington
United States	619	Scarborough	Maine

Sponsors (1)

Lead Sponsor	Collaborator
UCB BIOSCIENCES, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wechsler RT, Yates SL, Messenheimer J, Leroy R, Beller C, Doty P. Lacosamide for uncontrolled primary generalized tonic-clonic seizures: An open-label pilot study with 59-week extension. Epilepsy Res. 2017 Feb;130:13-20. doi: 10.1016/j.eplepsyres.2016.12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)		From Visit 1 to the end of study (Approximately 61 weeks)
Primary	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)		From Visit 1 to the end of study (Approximately 61 weeks)

External Links

•   FDA Safety Alerts and Recalls
•   Product Information