EUCTR2004-002855-15-GB
Active, not recruiting
Not Applicable
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.
ConditionsAmyotrophic Lateral Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Amyotrophic Lateral Sclerosis
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 480
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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