Back to resultsExtension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS) (ALSTAR OL)
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Talampanel
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Talampanel, Open-Label Study, Amyotrophic Lateral Sclerosis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Talampanel
Arm Description
Talampanel 50mg tid
Outcomes
Primary Outcome Measures
ALSFRS-R
Secondary Outcome Measures
Vital Signs, ECG, Adverse Event Reports
Full Information
NCT ID
NCT00982150
First Posted
September 22, 2009
Last Updated
August 16, 2013
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00982150
Brief Title
Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)
Acronym
ALSTAR OL
Official Title
A Multinational, Multicenter, Open Label Phase to Assess Tolerability and Safety of Talampanel 50mg Tid in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Core study unsuccessful
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Talampanel, Open-Label Study, Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
446 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Talampanel
Arm Type
Experimental
Arm Description
Talampanel 50mg tid
Intervention Type
Drug
Intervention Name(s)
Talampanel
Intervention Description
50mg capsules tid
Primary Outcome Measure Information:
Title
ALSFRS-R
Time Frame
every 4 weeks
Secondary Outcome Measure Information:
Title
Vital Signs, ECG, Adverse Event Reports
Time Frame
every 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
12. IPD Sharing Statement
Learn more about this trial
Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)
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