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Trial record 43 of 538 for:    ALS (Amyotrophic Lateral Sclerosis)

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00982150
Recruitment Status : Terminated (Core study unsuccessful)
First Posted : September 23, 2009
Last Update Posted : August 26, 2013
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Tracking Information
First Submitted Date  ICMJE September 22, 2009
First Posted Date  ICMJE September 23, 2009
Last Update Posted Date August 26, 2013
Study Start Date  ICMJE September 2009
Actual 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
Vital Signs, ECG, Adverse Event Reports [ Time Frame: every 26 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE Drug: Talampanel
50mg capsules tid
Study Arms  ICMJE 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
Actual Enrollment  ICMJE
 (submitted: September 22, 2009)
446
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Belgium,   Canada,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Spain,   United States
 
Administrative Information
NCT Number  ICMJE NCT00982150
Other Study ID Numbers  ICMJE ALS-TAL-201-OL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries
Study Sponsor  ICMJE Teva Pharmaceutical Industries
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Teva Pharmaceutical Industries
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP