Clinical Trial: Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Multinational, Multicenter, Open Label Phase to Assess Tolerability and Safety of Talampanel 50mg Tid in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Brief Summary: This will be an open label treatment extension phase in patients with ALS who have previously participated in the double blind, placebo-controlled ALS-TAL-201 study. This study will make talampanel treatment available to all subjects who completed the double blind placebo-controlled phase of ALS-TAL-201 study and where the investigator and patient consider it to be in the patient's interest to receive talampanel 50mg three times daily (tid). It will also enable the exploration of long-term safety and tolerability of talampanel 50mg tid.

Detailed Summary:
Sponsor: Teva Pharmaceutical Industries

Current Primary Outcome: ALSFRS-R [ Time Frame: every 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Vital Signs, ECG, Adverse Event Reports [ Time Frame: every 26 weeks ]

Original Secondary Outcome: Same as current

Information By: Teva Pharmaceutical Industries

Dates:
Date Received: September 22, 2009
Date Started: September 2009
Date Completion:
Last Updated: August 16, 2013
Last Verified: August 2013