A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230074
• Other study ID #: CTCH346A2211E1
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2005
• Last updated: November 22, 2011
• Start date: November 2004
• Est. completion date: February 2005

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346 compared to placebo in patients with mild or mild to moderate stages of ALS.

Description:

This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346 compared to placebo in patients with mild or mild to moderate stages of ALS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Completed original protocol, Study No. CTCH346A2211

• Be capable of satisfying the requirements of the extension protocol and must sign informed consent after the nature of the extension protocol has been fully explained

Exclusion Criteria:

• Exclusion criteria as described in the original protocol will remain applicable into the extension protocol

Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• TCH346

Locations

Country	Name	City	State
United States	Novartis	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
Secondary	Survival time
Secondary	Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit)