Clinical trial NCT00072709: Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS
Lou Gehrig's disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2003-11-11
Enrollment: 551
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
Secondary outcomes:
measure: Survival time
measure: Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit except screening)
measure: Neurocognitive evaluation in a subset of patients(every visit except screening)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis USA
state: New Jersey
city: Vilvoorde
country: Belgium
facility: Novartis Belgium
city: Dorval
country: Canada
facility: Novartis CANADA
state: Quebec
city: Rueil-Malmaison
country: France
facility: Novartis France
city: Nuernberg
country: Germany
facility: Novartis Germany
city: Saronno
country: Italy
facility: Novartis Italy
city: Arnhem
country: Netherlands
facility: Novartis Netherlands
city: Bern
country: Switzerland
facility: Novartis Switzerland
city: Frimley
country: United Kingdom
facility: Novartis UK
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: