Back to resultsStudy Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TCH346
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS, Lou Gehrig's disease
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.
Sites / Locations
- Novartis USA
- Novartis Belgium
- Novartis CANADA
- Novartis France
- Novartis Germany
- Novartis Italy
- Novartis Netherlands
- Novartis Switzerland
- Novartis UK
Outcomes
Primary Outcome Measures
Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT00072709
First Posted
November 7, 2003
Last Updated
November 22, 2011
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00072709
Brief Title
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
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
ALS, Lou Gehrig's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
551 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
TCH346
Primary Outcome Measure Information:
Title
Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
Secondary Outcome Measure Information:
Title
Survival time
Title
Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit except screening)
Title
Neurocognitive evaluation in a subset of patients(every visit except screening)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis USA
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Facility Name
Novartis Belgium
City
Vilvoorde
Country
Belgium
Facility Name
Novartis CANADA
City
Dorval
State/Province
Quebec
Country
Canada
Facility Name
Novartis France
City
Rueil-Malmaison
Country
France
Facility Name
Novartis Germany
City
Nuernberg
Country
Germany
Facility Name
Novartis Italy
City
Saronno
Country
Italy
Facility Name
Novartis Netherlands
City
Arnhem
Country
Netherlands
Facility Name
Novartis Switzerland
City
Bern
Country
Switzerland
Facility Name
Novartis UK
City
Frimley
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS)
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