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

August 16, 2013 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

A Multinational, Multicenter, Open Label Phase to Assess Tolerability and Safety of Talampanel 50mg Tid in Subjects With Amyotrophic Lateral Sclerosis (ALS)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

446

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Talampanel
Talampanel 50mg tid
Drug: Talampanel
50mg capsules tid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ALSFRS-R
Time Frame: every 4 weeks
every 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Vital Signs, ECG, Adverse Event Reports
Time Frame: every 26 weeks
every 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

September 22, 2009

First Posted (Estimate)

September 23, 2009

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 16, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALS-TAL-201-OL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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