Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00072709 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study of Amyotrophic Lateral Sclerosis, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 551
- Enrollment target
- 9
- Study locations
NCT00072709: Completed Phase 2 study of Amyotrophic Lateral Sclerosis, sponsored by Novartis Pharmaceuticals.
NCT00072709 is a Phase 2 study of Amyotrophic Lateral Sclerosis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 551 participants, below the 893-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (38% lower). The trial reports 9 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00072709, a Phase 2 study of Amyotrophic Lateral Sclerosis, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 551 participants
- Enrollment target
- 9
- Study locations
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 |
What the finished NCT00072709 record still lists
NCT00072709 is an interventional study that assigns participants to a tested intervention. The registered 551 participants enrollment target is mid-sized for trials with a published cap, below the 893-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (38% lower).
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.
NCT00072709 lists 9 locations in 3 states (Other, New Jersey, Quebec).
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.
What interventions are being tested in trial NCT00072709?
The interventions under investigation include: TCH346 (DRUG).
Who is sponsoring clinical trial NCT00072709?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00072709's enrollment target sits among peer trials
551 20th of 102 higher than 83 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Dazucorilant in Patients With Amyotrophic Lateral Sclerosis
RECRUITING · Phase 2
-
HEALEY ALS Platform Trial - Master Protocol
RECRUITING · Phase 2
-
RAPA-501 Therapy for ALS
RECRUITING · Phase 2
-
A Study of Ranolazine in ALS
RECRUITING · Phase 2
-
Rho Kinase Inhibitor in Amyotrophic Lateral Sclerosis (REAL)
ACTIVE NOT RECRUITING · Phase 2
-
Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06217809 · 552 participants · NA
EmpowHer is Prevention Curriculum for Youth Ages 10-15 Years.
- NCT07146022 · 552 participants · Phase 3
Safety and Efficacy of VDPHL01 in Females With Androgenetic Alopecia (AGA)
- NCT01852448 · 550 participants
Genetics of Insulin and Incretins in Cystic Fibrosis
- NCT02995252 · 550 participants
The HOPE Study: Characterizing Patients With Hepatitis B and C
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia