Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)

A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group, Multicenter, Dose-Ranging Study Evaluating Four Oral Doses of TCH346 (1.0, 2.5, 7.5 and 15 mg) Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00072709

Enrollment

551

Registered

2003-11-11

Start date

2003-09-30

Completion date

2004-12-31

Last updated

2011-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS, Lou Gehrig's disease

Brief 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).

Interventions

DRUGTCH346

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Rate of functional decline as defined by the ALS Functional Rating Scale-Revised	—

Secondary

Measure	Time frame
Survival time	—
Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit except screening)	—
Neurocognitive evaluation in a subset of patients(every visit except screening)	—

Countries

Belgium, Canada, France, Germany, Italy, Netherlands, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026