Status:
TERMINATED
Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 tr...
Eligibility Criteria
Inclusion
- Patients must have completed 52 weeks of treatment of the double blind placebo-controlled phase of ALS-TAL-201.
- Women must be postmenopausal, surgically sterile, or using adequate birth control methods.
- Patients must be willing and able to give written informed consent prior to performing any open-label study procedures.
Exclusion
- Patients with ECG signs of Brugada syndrome and/ or complete or incomplete Right Bundle Branch Block
- Patients using any of the following:
- Chronic use of lithium carbonate
- Chronic use of mecasermin (rhIGF-1)
- Chronic use of minocycline
- Chronic use of more than 600mg/day coenzyme Q10
- Chronic use of any marketed drug, if its use was not clearly indicated for any underlying medical condition other than ALS (symptomatic drugs for ALS and supplements allowed)
- Patients participating in any other investigational drug study and use of any other investigational drug
- Patients taking drugs that may interact with Talampanel
- Females who are pregnant or nursing.
- Females of child-bearing potential who do not practice medically acceptable methods of contraception.
- Any condition of the patient which the investigator feels may interfere with participation in the study.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
446 Patients enrolled
Trial Details
Trial ID
NCT00982150
Start Date
September 1 2009
End Date
June 1 2010
Last Update
August 26 2013
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