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Completed

NCT Number: NCT00696332

Talampanel for Amyotrophic Lateral Sclerosis (ALS)

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.

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Key information

Conditions

ALS

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Academic Hospital University of Leuven - ALS dept, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Inclusion criteria

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

Exclusion criteria

  • The use of invasive or non-invasive ventilation.
  • Subject having undergone gastrostomy.
  • Subject with any clinically significant or unstable medical condition.
  • Subject participating in any other investigational drug trial or using investigational drug (within 12 weeks prior to screening and thereafter).
  • Females who are pregnant or nursing.

Treatment and study plan

Talampanel

Drug

capsules Talampanel, 3 times per day, 52 weeks

Other names: AMPA antagonist

Placebo

Other

capsules, placebo, 3 times a day, for 52 weeks

Primary outcomes

  1. Change in ALS Functional Rating Score (ALSFRS-R slope)

    Time frame: 52 weeks

Secondary outcomes

  1. Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation.

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study 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)

Acronym: ALS

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 12, 2008
Registry last updated
Oct 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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