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Completed Phase 2 Interventional

A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)

ClinicalTrials.gov ID: NCT00230074

Public ClinicalTrials.gov record NCT00230074. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 3, 2026, 11:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346 compared to placebo in patients with mild or mild to moderate stages of ALS.

Study identification

NCT ID
NCT00230074
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Novartis
Industry
Enrollment
350 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
21 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2004 (Type not available)
Primary completion
Feb 2005 (Actual)
Completion
Feb 2005 (Actual)
Last update posted
Nov 23, 2011

2004 – 2005

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Novartis East Hanover New Jersey 07936 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00230074, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 23, 2011 · Synced Oct 3, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00230074 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →