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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 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.

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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

Amyotrophic Lateral Sclerosis

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

FieldValue
Enrollment Target 551 participants
Start Date 2003-09
Est. Completion 2004-12
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT00072709

The ClinicalTrials.gov registry entry for NCT00072709 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 551 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 893-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (38% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 9 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.