Clinical trial NCT00696332: Talampanel for Amyotrophic Lateral Sclerosis (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
Overall status: COMPLETED
Phase: PHASE2
Conditions: ALS
Keywords: ALS
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-12
Enrollment: 559
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

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.

Primary outcomes:
measure: Change in ALS Functional Rating Score (ALSFRS-R slope)
timeFrame: 52 weeks
Secondary outcomes:
measure: Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center
state: California
city: Kansas City
country: United States
facility: University of Kansas Medical Center - Dept of Neurology
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins OPC - Meyer Bldg
state: Maryland
city: Charlestown
country: United States
facility: Massachusetts General Hospital-Neurology Clinical Trials Unit
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Columbia University - Neurology Institute
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Leuven
country: Belgium
facility: Academic Hospital University of Leuven - ALS dept
city: Vancouver
country: Canada
facility: ALS Centre
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre Motor Neuro Diseases Clinic
state: Ontario
city: Montreal
country: Canada
facility: Montreal Neurological Institute
state: Quebec
city: Marseille Cedex 5
country: France
facility: C.H.U. La Timone - Service de Neurologie
city: Montpellier Cedex 5
country: France
facility: C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques
city: Paris
country: France
facility: Hopital La Pitie Salpetriere - Federation de Neurologie
city: Berlin
country: Germany
facility: Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik
city: Bochum
country: Germany
facility: Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik
city: Ulm
country: Germany
facility: Universitaet Ulm
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Neurology
city: Tel Aviv
country: Israel
facility: Sourasky MC -EMG Unit
city: Lissone (MI)
country: Italy
facility: Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone
city: Milano
country: Italy
facility: Centro Clinico NEMO
city: Torino
country: Italy
facility: Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Madrid
country: Spain
facility: Hospital Carlos III
Study officials:
References: