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

NCT ID: NCT00072709

Last Updated: 2011-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

551 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2004-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis

Keywords

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ALS Lou Gehrig's disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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TCH346

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis USA

East Hanover, New Jersey, United States

Site Status

Novartis Belgium

Vilvoorde, , Belgium

Site Status

Novartis CANADA

Dorval, Quebec, Canada

Site Status

Novartis France

Rueil-Malmaison, , France

Site Status

Novartis Germany

Nuremberg, , Germany

Site Status

Novartis Italy

Saronno, , Italy

Site Status

Novartis Netherlands

Arnhem, , Netherlands

Site Status

Novartis Switzerland

Bern, , Switzerland

Site Status

Novartis UK

Frimley, , United Kingdom

Site Status

Countries

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United States Belgium Canada France Germany Italy Netherlands Switzerland United Kingdom

Other Identifiers

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CTCH346A2211

Identifier Type: -

Identifier Source: org_study_id