Talampanel for Amyotrophic Lateral Sclerosis (ALS) (ALS)

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)

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.

Study Overview

• Status: Completed
• Conditions: ALS
• Intervention / Treatment: Drug: Talampanel; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 559
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, B-3000
    • Academic Hospital University of Leuven - ALS dept
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 2G9
      • ALS Centre
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre Motor Neuro Diseases Clinic
  • Quebec
    • Montreal, Quebec, Canada, H3A 2B4
      • Montreal Neurological Institute
• France
  • Marseille Cedex 5, France, 13385
    • C.H.U. La Timone - Service de Neurologie
  • Montpellier Cedex 5, France, 34295
    • C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques
  • Paris, France, 75013
    • Hopital La Pitie Salpetriere - Federation de Neurologie
• Germany
  • Berlin, Germany, 13353
    • Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik
  • Bochum, Germany, 44789
    • Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik
  • Ulm, Germany, 89081
    • Universitaet Ulm
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis University, Department of Neurology
• Israel
  • Tel Aviv, Israel, 64239
    • Sourasky MC -EMG Unit
• Italy
  • Lissone (MI), Italy, 20035
    • Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone
  • Milano, Italy, 20162
    • Centro Clinico NeMO
  • Torino, Italy, 10126
    • Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht
• Spain
  • Madrid, Spain, 28029
    • Hospital Carlos III
• United States
  • California
    • San Francisco, California, United States, 94115
      • CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center - Dept of Neurology
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins OPC - Meyer Bldg
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Massachusetts General Hospital-Neurology Clinical Trials Unit
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10032
      • Columbia University - Neurology Institute
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Talampanel 50mg; 50mg Talampanel 3 times per day	Drug: Talampanel; capsules Talampanel, 3 times per day, 52 weeks; Other Names: AMPA antagonist
Experimental: Talampanel 25mg; 25mg Talampanel 3 times per day	Drug: Talampanel; capsules Talampanel, 3 times per day, 52 weeks; Other Names: AMPA antagonist
Placebo Comparator: Placebo; placebo 3 times per day	Other: placebo; capsules, placebo, 3 times a day, for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in ALS Functional Rating Score (ALSFRS-R slope)	52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation.	52 weeks

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: June 10, 2008
• First Submitted That Met QC Criteria: June 11, 2008
• First Posted (Estimate): June 12, 2008

Study Record Updates

• Last Update Posted (Estimate): October 21, 2011
• Last Update Submitted That Met QC Criteria: October 20, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: ALS
• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Agents; Excitatory Amino Acid Agonists; alpha-Amino-3-hydroxy-5-methyl-4-isoxazolepropionic Acid
• Other Study ID Numbers: ALS-TAL-201 (ALSTAR); ALSTAR