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Talampanel for Amyotrophic Lateral Sclerosis (ALS) (ALS)

Primary Purpose

ALS

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Talampanel
Talampanel
placebo
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ALS focused on measuring ALS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center
  • University of Kansas Medical Center - Dept of Neurology
  • Johns Hopkins OPC - Meyer Bldg
  • Massachusetts General Hospital-Neurology Clinical Trials Unit
  • Mayo Clinic
  • Columbia University - Neurology Institute
  • SUNY Upstate Medical University
  • Academic Hospital University of Leuven - ALS dept
  • ALS Centre
  • London Health Sciences Centre Motor Neuro Diseases Clinic
  • Montreal Neurological Institute
  • C.H.U. La Timone - Service de Neurologie
  • C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques
  • Hopital La Pitie Salpetriere - Federation de Neurologie
  • Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik
  • Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik
  • Universitaet Ulm
  • Semmelweis University, Department of Neurology
  • Sourasky MC -EMG Unit
  • Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone
  • Centro Clinico NEMO
  • Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze
  • Universitair Medisch Centrum Utrecht
  • Hospital Carlos III

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Talampanel 50mg

Talampanel 25mg

Placebo

Arm Description

50mg Talampanel 3 times per day

25mg Talampanel 3 times per day

placebo 3 times per day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 10, 2008
Last Updated
October 20, 2011
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00696332
Brief Title
Talampanel for Amyotrophic Lateral Sclerosis (ALS)
Acronym
ALS
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ALS
Keywords
ALS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
559 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Talampanel 50mg
Arm Type
Experimental
Arm Description
50mg Talampanel 3 times per day
Arm Title
Talampanel 25mg
Arm Type
Experimental
Arm Description
25mg Talampanel 3 times per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo 3 times per day
Intervention Type
Drug
Intervention Name(s)
Talampanel
Other Intervention Name(s)
AMPA antagonist
Intervention Description
capsules Talampanel, 3 times per day, 52 weeks
Intervention Type
Drug
Intervention Name(s)
Talampanel
Other Intervention Name(s)
AMPA antagonist
Intervention Description
capsules Talampanel, 3 times per day, 52 weeks
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
capsules, placebo, 3 times a day, for 52 weeks
Primary Outcome Measure Information:
Title
Change in ALS Functional Rating Score (ALSFRS-R slope)
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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.
Facility Information:
Facility Name
CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Kansas Medical Center - Dept of Neurology
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins OPC - Meyer Bldg
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital-Neurology Clinical Trials Unit
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Columbia University - Neurology Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Academic Hospital University of Leuven - ALS dept
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
ALS Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2G9
Country
Canada
Facility Name
London Health Sciences Centre Motor Neuro Diseases Clinic
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Montreal Neurological Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
C.H.U. La Timone - Service de Neurologie
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital La Pitie Salpetriere - Federation de Neurologie
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Universitaet Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Semmelweis University, Department of Neurology
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Sourasky MC -EMG Unit
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone
City
Lissone (MI)
ZIP/Postal Code
20035
Country
Italy
Facility Name
Centro Clinico NEMO
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Hospital Carlos III
City
Madrid
ZIP/Postal Code
28029
Country
Spain

12. IPD Sharing Statement

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Talampanel for Amyotrophic Lateral Sclerosis (ALS)

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