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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00230074
• Date of registration: 28/09/2005
• Prospective Registration: No
• Primary sponsor: Novartis
• Public title: A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
• Scientific title: A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
• Date of first enrolment: November 2004
• Target sample size: 350
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00230074
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

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.



Age minimum: 21 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: TCH346

Primary Outcome(s)

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

Secondary Outcome(s)

Survival time

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

Secondary ID(s)

CTCH346A2211E1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors