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Talampanel for Amyotrophic Lateral Sclerosis (ALS) (ALS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00696332
First Posted: June 12, 2008
Last Update Posted: October 21, 2011
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.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
  Purpose
The purpose of this study is to assess the efficacy, tolerability and safety of oral administration of talampanel compared to a placebo in subjects with ALS.

Condition Intervention Phase
ALS Drug: Talampanel Other: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of Talampanel in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Change in ALS Functional Rating Score (ALSFRS-R slope) [ Time Frame: 52 weeks ]

Secondary Outcome Measures:
  • Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation. [ Time Frame: 52 weeks ]

Enrollment: 559
Study Start Date: September 2008
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Talampanel 50mg
50mg Talampanel 3 times per day
Drug: Talampanel
capsules Talampanel, 3 times per day, 52 weeks
Other Name: AMPA antagonist
Experimental: Talampanel 25mg
25mg Talampanel 3 times per day
Drug: Talampanel
capsules Talampanel, 3 times per day, 52 weeks
Other Name: AMPA antagonist
Placebo Comparator: Placebo
placebo 3 times per day
Other: placebo
capsules, placebo, 3 times a day, for 52 weeks

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Subjects with sporadic or familial ALS classified as definite, probable, or laboratory-supported probable ALS according to the revised El Escorial criteria.

Inclusion Criteria:

  1. Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria.
  2. Subject has experienced his/her first ALS symptoms within 3 years prior to the screening visit.
  3. Slow VC test equal to or greater than 70% of the predicted value.
  4. The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points.
  5. Subjects taking riluzole must be on a stable dose for at least 8 weeks prior to screening visit.
  6. Ages 18-80 (inclusive)

Exclusion Criteria:

  1. The use of invasive or non-invasive ventilation.
  2. Subject having undergone gastrostomy.
  3. Subject with any clinically significant or unstable medical condition.
  4. Subject participating in any other investigational drug trial or using investigational drug (within 12 weeks prior to screening and thereafter).
  5. Females who are pregnant or nursing.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696332


  Show 24 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
  More Information

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00696332     History of Changes
Other Study ID Numbers: ALS-TAL-201 (ALSTAR)
ALSTAR
First Submitted: June 10, 2008
First Posted: June 12, 2008
Last Update Posted: October 21, 2011
Last Verified: October 2011

Keywords provided by Teva Pharmaceutical Industries:
ALS

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