Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)
NCT00982150 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 446
Last updated 2013-08-26
Summary
This will be an open label treatment extension phase in patients with ALS who have previously participated in the double blind, placebo-controlled ALS-TAL-201 study. This study will make talampanel treatment available to all subjects who completed the double blind placebo-controlled phase of ALS-TAL-201 study and where the investigator and patient consider it to be in the patient's interest to receive talampanel 50mg three times daily (tid). It will also enable the exploration of long-term safety and tolerability of talampanel 50mg tid.
Conditions
Interventions
- DRUG
-
Talampanel
50mg capsules tid
Sponsors & Collaborators
-
Teva Branded Pharmaceutical Products R&D, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2010-06-30
- Completion
- 2010-06-30
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