NCT00982150

Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 446 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	Talampanel	50mg capsules tid

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2009-09-23
• Last updated: 2013-08-26