Expired Study
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New York, New York 10032


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.


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


Study is Available At:


Original ID:

CTCH346 0102


NCT ID:

NCT00036413


Secondary ID:


Study Acronym:


Brief Title:

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


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.


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

44


Enrollment Type:

Actual


Overall Contact Information

Official Name:Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Study Dates

Start Date:January 2002
Completion Date:October 2002
Completion Type:Actual
Primary Completion Date:October 2002
Primary Completion Type:Actual
Verification Date:November 2011
Last Changed Date:November 22, 2011
First Received Date:May 9, 2002

Study Outcomes

Outcome Type:Primary Outcome
Measure:Safety of three oral doses of TCH346 versus placebo administered for up to 12 weeks to patients with ALS
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Biomarker assessments at week 12
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:TCH346

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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