Status:
COMPLETED
Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
Brief Summary
This is a global multicenter study designed to evaluate the safety and clinical effects of 4 oral doses of TCH346 (1.0, 2.5, 7.5, and 15 mg) compared to placebo in patients with mild or mild to modera...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- clinical diagnosis of laboratory-supported probable, probable, or definite ALS;
- sporadic or familial ALS;
- ALS symptom onset for no more than 3 yrs at study entry;
- FVC equal to or more than 70%;
- patients who are either riluzole naive or patients who are receiving concomitant treatment with riluzole at a stable dose of riluzole (50 mg bid) at study start.
- Exclusion criteria:
- Known or suspected chronic infectious disease including HIV, hepatitis B, or hepatitis C.
- Clinically significant ECG abnormalities.
- Known hypersensitivity to study drug or related drugs (e.g. selegiline, MAO-A and B inhibitors, or tricyclic antidepressants).
- Patients treated with potent inhibitors of CYP1A2 or CYP3A4 (a list of such inhibitors will be provided to the investigator).
- Treatment with MAO-A and B inhibitors (including selegiline) within the past 30 days.
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
551 Patients enrolled
Trial Details
Trial ID
NCT00072709
Start Date
September 1 2003
End Date
December 1 2004
Last Update
November 24 2011
Active Locations (9)
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1
Novartis USA
East Hanover, New Jersey, United States, 07936
2
Novartis Belgium
Vilvoorde, Belgium
3
Novartis CANADA
Dorval, Quebec, Canada
4
Novartis France
Rueil-Malmaison, France