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

Novartis350 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

350

Conditions

Amyotrophic Lateral Sclerosis

Interventions

TCH346DRUG

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Rate of functional decline as defined by the ALS Functional Rating Scale-Revised

Secondary Outcomes

Survival time

Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.