Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)
NCT00072709 · View on ClinicalTrials.gov ↗
Study 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 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).
Conditions Studied
Interventions
- DRUG TCH346
Study Locations (9)
Other
- Novartis Belgium — Vilvoorde
- Novartis France — Rueil-Malmaison
- Novartis Germany — Nuremberg
- Novartis Italy — Saronno
- Novartis Netherlands — Arnhem
- Novartis Switzerland — Bern
- Novartis UK — Frimley
New Jersey
- Novartis USA — East Hanover
Quebec
- Novartis CANADA — Dorval
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 551 participants |
| Start Date | 2003-09 |
| Est. Completion | 2004-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00072709
The ClinicalTrials.gov registry entry for NCT00072709 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 551 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention — of which TCH346 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00072709 reports 9 study locations spanning 3 distinct geographic areas — top geographies include Other, New Jersey, Quebec. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00072709 about?
NCT00072709 is a clinical study titled "Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)". 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 ...
What is the current status of trial NCT00072709?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 551 participants. The study started on 2003-09. Estimated completion is 2004-12.
What conditions does trial NCT00072709 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00072709?
The interventions under investigation include: TCH346 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00072709?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00072709 being conducted?
This trial has 9 study locations across New Jersey, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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