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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: August 16, 2013
Last verified: August 2013
  Purpose
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.

Condition Intervention Phase
Amyotrophic Lateral Sclerosis Drug: Talampanel Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multinational, Multicenter, Open Label Phase to Assess Tolerability and Safety of Talampanel 50mg Tid in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • ALSFRS-R [ Time Frame: every 4 weeks ]

Secondary Outcome Measures:
  • Vital Signs, ECG, Adverse Event Reports [ Time Frame: every 26 weeks ]

Enrollment: 446
Study Start Date: September 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Talampanel
Talampanel 50mg tid
Drug: Talampanel
50mg capsules tid

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00982150     History of Changes
Other Study ID Numbers: ALS-TAL-201-OL
Study First Received: September 22, 2009
Last Updated: August 16, 2013

Keywords provided by Teva Pharmaceutical Industries:
Talampanel
Open-Label Study
Amyotrophic Lateral Sclerosis

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on June 23, 2017