Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)
Completed · Phase 2
Conditions studied: Amyotrophic Lateral Sclerosis
In brief
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 moderate stages of ALS. The study consists of 3 phases: screening (up to 2 weeks), run-in (16 weeks), and a double-blind treatment phase of variable duration (at least 24 weeks).
Key facts
- Study ID
- NCT00072709
- Run by
- Novartis Pharmaceuticals
- People needed
- 551
- Starts
- 2003-09-01
- Expected to finish
- 2004-12-01
- Last updated by the study team
- 2011-11-24
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Novartis USA — East Hanover, New Jersey, United States
- Novartis Belgium — Vilvoorde, Belgium
- Novartis CANADA — Dorval, Quebec, Canada
- Novartis France — Rueil-Malmaison, France
- Novartis Germany — Nuremberg, Germany
- Novartis Italy — Saronno, Italy
- Novartis Netherlands — Arnhem, Netherlands
- Novartis Switzerland — Bern, Switzerland
- Novartis UK — Frimley, United Kingdom
Full record on ClinicalTrials.gov
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