A 12-week, Multicenter, Safety and Dose-ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral Sclerosis

A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Safety and Dose-ranging Study of Three Oral Doses (0.5 mg, 2.5 mg and 10 mg Once Daily) of TCH346 in Patients With Amyotrophic Lateral Sclerosis.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00036413

Enrollment

Registered

2002-05-10

Start date

2002-01-31

Completion date

2002-10-31

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)

Brief summary

This study is the first to be performed in Amyotrophic Lateral Sclerosis (ALS) patients with the novel compound TCH346. Its purpose is to evaluate the safety and clinical effects of 3 dose levels of TCH 346 compared to placebo in patients with a clinical diagnosis of laboratory-supported probable, probable or definite ALS. The study will require patients to visit the study center a total of at least 7 times over the course of up to 14 weeks. The study consists of 2 phases: A screening phase (up to 2 weeks) when patients will be evaluated for eligibility to participate in the study, and a double-blind treatment phase (12 weeks) when patients will receive daily doses of either TCH346 or placebo and will be evaluated for clinical effects. In addition, patients eligible to participate in this study will be required to have 3 magnetic resonance spectroscopic (MRS) scans. The MRS is a non-invasive, painless, brain scan. The MRS will require traveling to a designated center in Montreal, Canada, which is very experienced in performing such MRS scans in ALS patients.

Interventions

DRUGTCH346

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

* clinical diagnosis of laboratory-supported probable, probable, or definite ALS; * have sporadic or familial ALS; * have shown ALS symptom onset for no more than 3 yrs., inclusive, prior to randomization; * FVC of \>60%; * ability to tolerate MRS evaluation

Design outcomes

Primary

Measure	Time frame
Safety of three oral doses of TCH346 versus placebo administered for up to 12 weeks to patients with ALS	—

Secondary

Measure	Time frame
Biomarker assessments at week 12	—

Countries

United States

Outcome results

None listed

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