Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
559 participants
INTERVENTIONAL
2008-09-30
2010-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Talampanel 50mg
50mg Talampanel 3 times per day
Talampanel
capsules Talampanel, 3 times per day, 52 weeks
Talampanel 25mg
25mg Talampanel 3 times per day
Talampanel
capsules Talampanel, 3 times per day, 52 weeks
Placebo
placebo 3 times per day
placebo
capsules, placebo, 3 times a day, for 52 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Talampanel
capsules Talampanel, 3 times per day, 52 weeks
Talampanel
capsules Talampanel, 3 times per day, 52 weeks
placebo
capsules, placebo, 3 times a day, for 52 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
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.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center
San Francisco, California, United States
University of Kansas Medical Center - Dept of Neurology
Kansas City, Kansas, United States
Johns Hopkins OPC - Meyer Bldg
Baltimore, Maryland, United States
Massachusetts General Hospital-Neurology Clinical Trials Unit
Charlestown, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Columbia University - Neurology Institute
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Academic Hospital University of Leuven - ALS dept
Leuven, , Belgium
ALS Centre
Vancouver, British Columbia, Canada
London Health Sciences Centre Motor Neuro Diseases Clinic
London, Ontario, Canada
Montreal Neurological Institute
Montreal, Quebec, Canada
C.H.U. La Timone - Service de Neurologie
Marseille, , France
C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques
Montpellier, , France
Hopital La Pitie Salpetriere - Federation de Neurologie
Paris, , France
Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik
Berlin, , Germany
Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik
Bochum, , Germany
Universitaet Ulm
Ulm, , Germany
Semmelweis University, Department of Neurology
Budapest, , Hungary
Sourasky MC -EMG Unit
Tel Aviv, , Israel
Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone
Lissone (MI), , Italy
Centro Clinico NEMO
Milan, , Italy
Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze
Torino, , Italy
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Hospital Carlos III
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ALSTAR
Identifier Type: -
Identifier Source: secondary_id
ALS-TAL-201 (ALSTAR)
Identifier Type: -
Identifier Source: org_study_id