Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS) (ALSTAR OL)

This study has been terminated.

(Core study unsuccessful)

Sponsor:

Information provided by (Responsible Party):

Teva Pharmaceutical Industries

ClinicalTrials.gov Identifier:

NCT00982150

First received: September 22, 2009

Last updated: June 5, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 22, 2009
Last Updated Date	June 5, 2012
Start Date ^ICMJE	September 2009
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 22, 2009)	ALSFRS-R [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00982150 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 22, 2009)	Vital Signs, ECG, Adverse Event Reports [ Time Frame: every 26 weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)
Official Title ^ICMJE	A Multinational, Multicenter, Open Label Phase to Assess Tolerability and Safety of Talampanel 50mg Tid in Subjects With Amyotrophic Lateral Sclerosis (ALS)
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Amyotrophic Lateral Sclerosis
Intervention ^ICMJE	Drug: Talampanel 50mg capsules tid
Study Arm (s)	Experimental: Talampanel Talampanel 50mg tid Intervention: Drug: Talampanel
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	446
Completion Date	June 2010
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00982150
Other Study ID Numbers ^ICMJE	ALS-TAL-201-OL
Has Data Monitoring Committee	Yes
Responsible Party	Teva Pharmaceutical Industries
Study Sponsor ^ICMJE	Teva Pharmaceutical Industries
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Teva Pharmaceutical Industries
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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