- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00036413
A 12-week, Multicenter, Safety and Dose-ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral Sclerosis
November 22, 2011 updated by: Novartis Pharmaceuticals
A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Safety and Dose-ranging Study of Three Oral Doses (0.5 mg, 2.5 mg and 10 mg Once Daily) of TCH346 in Patients With Amyotrophic Lateral Sclerosis.
This study is the first to be performed in Amyotrophic Lateral Sclerosis (ALS) patients with the novel compound TCH346.
Its purpose is to evaluate the safety and clinical effects of 3 dose levels of TCH 346 compared to placebo in patients with a clinical diagnosis of laboratory-supported probable, probable or definite ALS.
The study will require patients to visit the study center a total of at least 7 times over the course of up to 14 weeks.
The study consists of 2 phases: A screening phase (up to 2 weeks) when patients will be evaluated for eligibility to participate in the study, and a double-blind treatment phase (12 weeks) when patients will receive daily doses of either TCH346 or placebo and will be evaluated for clinical effects.
In addition, patients eligible to participate in this study will be required to have 3 magnetic resonance spectroscopic (MRS) scans.
The MRS is a non-invasive, painless, "brain scan".
The MRS will require traveling to a designated center in Montreal, Canada, which is very experienced in performing such MRS scans in ALS patients.
Study Overview
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10032
- Neurological Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- clinical diagnosis of laboratory-supported probable, probable, or definite ALS;
- have sporadic or familial ALS;
- have shown ALS symptom onset for no more than 3 yrs., inclusive, prior to randomization;
- FVC of >60%;
- ability to tolerate MRS evaluation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety of three oral doses of TCH346 versus placebo administered for up to 12 weeks to patients with ALS
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Secondary Outcome Measures
Outcome Measure |
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Biomarker assessments at week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Primary Completion (Actual)
October 1, 2002
Study Completion (Actual)
October 1, 2002
Study Registration Dates
First Submitted
May 9, 2002
First Submitted That Met QC Criteria
May 9, 2002
First Posted (Estimate)
May 10, 2002
Study Record Updates
Last Update Posted (Estimate)
November 24, 2011
Last Update Submitted That Met QC Criteria
November 22, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTCH346 0102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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