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

Completed · Phase 2

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT00230074

Run by

Novartis

People needed

350

Starts

2004-11-01

Expected to finish

2005-02-01

Last updated by the study team

2011-11-23

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Exclusion criteria as described in the original protocol will remain applicable into the extension protocol
• Other protocol-defined exclusion criteria may apply.

Where it is running

• Novartis — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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