A long-term extension to a randomized, double-blind, placebo-controlled, stratified, parallel-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 (1.0, 2.5, 7.5 and 15mg) administered once daily in patients with Amyotrophic Lateral Sclerosis.

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: EUCTR2004-002855-15-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-02
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

In addition to having met the inclusion criteria described in the original protocol, to participate in the extension study, patients must:
- have completed the original protocol, Study No. CTCH346A2211
- be capable of satisfying the requirements of the extension study protocol and must sign the informed consent after the nature of the extension study protocol has been fully explained.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria as described in the original protocol will remain applicable into the extension protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the long-term safety and tolerability of TCH346 at the most clinically effective dose (as determined by data analysis at the completion of Study 2211) administered once daily in patients with Amyotrophic Lateral Sclerosis.;Secondary Objective: - To determine the long-term efficacy of TCH346 based on clinical functionality (ALSFRS slope of progression) and survival.<br>- To characterize the long term PK/PD relationship in ALS patients receiving the same TCH346 dose.;Primary end point(s): Primary Efficacy assessment is the rate of functional decline in ALS patients as defined by the slope of ALSFRS-R.<br>The evaluations completed during the double-blind treatment phase will continue to be collected at specific intervals during the open-label phase.