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

• ClinicalTrials.gov Identifier: NCT00072709
• Recruitment Status: Completed
• First Posted: November 11, 2003
• Last Update Posted: November 24, 2011
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Amyotrophic Lateral Sclerosis	Drug: TCH346	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 551 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: September 2003
• Actual Primary Completion Date: December 2004
• Actual Study Completion Date: December 2004

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Rate of functional decline as defined by the ALS Functional Rating Scale-Revised

Secondary Outcome Measures :

1. Survival time
2. Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit except screening)
3. Neurocognitive evaluation in a subset of patients(every visit except screening)

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, New Jersey

Novartis USA

East Hanover, New Jersey, United States, 07936

Belgium

Novartis Belgium

Vilvoorde, Belgium

Canada, Quebec

Novartis CANADA

Dorval, Quebec, Canada

France

Novartis France

Rueil-Malmaison, France

Germany

Novartis Germany

Nuernberg, Germany

Italy

Novartis Italy

Saronno, Italy

Netherlands

Novartis Netherlands

Arnhem, Netherlands

Switzerland

Novartis Switzerland

Bern, Switzerland

United Kingdom

Novartis UK

Frimley, United Kingdom

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00072709 History of Changes
• Other Study ID Numbers: CTCH346A2211
• First Posted: November 11, 2003
• Last Update Posted: November 24, 2011
• Last Verified: November 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

ALS; Lou Gehrig's disease

Additional relevant MeSH terms:

Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis; Pathologic Processes; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases