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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00072709
• Date of registration: 07/11/2003
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)
• Scientific 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
• Date of first enrolment: September 2003
• Target sample size: 551
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00072709
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 21 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: TCH346

Primary Outcome(s)

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

Secondary Outcome(s)

Survival time

Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit except screening)

Neurocognitive evaluation in a subset of patients(every visit except screening)

Secondary ID(s)

CTCH346A2211

Source(s) of Monetary Support

Please refer to primary and secondary sponsors