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

Amyotrophic Lateral Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00072709
• Other study ID #: CTCH346A2211
• Status: Completed
• Phase: Phase 2
• First received: November 7, 2003
• Last updated: November 22, 2011
• Start date: September 2003
• Est. completion date: December 2004

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 551
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• TCH346

Locations

Country	Name	City	State
Belgium	Novartis Belgium	Vilvoorde
Canada	Novartis CANADA	Dorval	Quebec
France	Novartis France	Rueil-Malmaison
Germany	Novartis Germany	Nuernberg
Italy	Novartis Italy	Saronno
Netherlands	Novartis Netherlands	Arnhem
Switzerland	Novartis Switzerland	Bern
United Kingdom	Novartis UK	Frimley
United States	Novartis USA	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
Secondary	Survival time
Secondary	Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit except screening)
Secondary	Neurocognitive evaluation in a subset of patients(every visit except screening)