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A 12-week, Multicenter, Safety and Dose-ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00036413
First received: May 9, 2002
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
 Drug: TCH346
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety of three oral doses of TCH346 versus placebo administered for up to 12 weeks to patients with ALS

Secondary Outcome Measures:
  • Biomarker assessments at week 12

Enrollment: 44
Study Start Date: January 2002
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036413

Locations
United States, New York
Neurological Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00036413     History of Changes
Other Study ID Numbers: CTCH346 0102
Study First Received: May 9, 2002
Last Updated: November 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
(ALS)

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013