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Sponsors and Collaborators: |
University of Lisbon H. Lundbeck A/S |
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Information provided by: | University of Lisbon |
ClinicalTrials.gov Identifier: | NCT00353665 |
To study the effect of Memantine (uncompetitive, moderate affinity, NMDA receptor antagonist that binds to the NMDA receptor channel, and regulates the calcium influx into the neurons), a drug used to treat Alzheimer´s disease, on the progression of ALS. Memantine is added to riluzole (the single drug approved to treat ALS)
Condition | Intervention | Phase |
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Amyotrophic Lateral Sclerosis |
Drug: Memantine Drug: memantine Drug: riluzole |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 2-3 - Memantine for Disability in Amyotrophic Lateral Sclerosis |
Estimated Enrollment: | 60 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 - active: Experimental
memantine + riluzole
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Drug: Memantine
10 mg bid
Drug: memantine
10 mg bid
Drug: riluzole
riluzole 50 mg bid
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2: Placebo Comparator
riluzole + placebo
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Drug: riluzole
riluzole 50 mg bid
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Phase 2/3 trial in ALS patients Double-blinded, parallel, randomized (2 blocs, bulbar/spinal onset)
Memantine + riluzole x Placebo + Memantine
Inclusion criteria:
Duration - 2 years
Evaluation - every 3 months
Primary outcome - ALS-FRS Secondary -SF36, Hamilton depression scale, motor unit number estimation, neurophysiological index, strength (clinical evaluation); side-effects
Intention to treat analysis
60 patients
number estimated for 50% change in decline rate of ALS-FRS
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mamede de Carvalho, MD | + 351 21 7805219 | mamedemg@mail.telepac.pt |
Portugal | |
Department of Neurology - Hospital de Santa Maria | Recruiting |
Lisbon, Portugal, 1649-028 | |
Sub-Investigator: Teresinha Evangelista, MD | |
Sub-Investigator: Susana Pinto, MD | |
Department of Neurology - Hospital de Santa Maria | Recruiting |
Lisbon, Portugal, 1649-028 | |
Contact: Mamede de Carvalho, MD + 351 217805219 mamedemg@mail.telepac.pt |
Principal Investigator: | Mamede de Carvalho, MD | Department of Neurology- Hospital de Santa Maria |
Responsible Party: | Instituto de Medicina Molecular ( Mamede de Carvalho ) |
Study ID Numbers: | 002-04 |
Study First Received: | July 18, 2006 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00353665 |
Health Authority: | Portugal: National Pharmacy and Medicines Institute |
amyotrophic lateral sclerosis motor neuron disease memantine clinical trial |
Riluzole Excitatory Amino Acids Spinal Cord Diseases Central Nervous System Diseases Sclerosis Degenerative motor system disease Neurodegenerative Diseases Motor neuron disease |
Dopamine Amyotrophic lateral sclerosis Neuromuscular Diseases Amyotrophic Lateral Sclerosis Memantine Lou Gehrig's disease Motor Neuron Disease |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Antiparkinson Agents Excitatory Amino Acid Agents Protective Agents |
Neuroprotective Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses Dopamine Agents Central Nervous System Agents Anticonvulsants Excitatory Amino Acid Antagonists |