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

Novartis

Status and phase

Completed

Phase 2

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Drug: TCH346

Study type

Interventional

Funder types

Industry

Identifiers

NCT00072709

CTCH346A2211

Details and patient eligibility

About

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).

Enrollment

551 patients

Sex

All

Ages

21 to 80 years old

Volunteers

No 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.