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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00409721 |
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Date of registration:
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08/12/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Amyotrophic Lateral Sclerosis (ALS)
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Scientific title:
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A Randomized, Double-blind, Dose Ranging Study to Determine the Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Patients With ALS |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00409721 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Sanjay Kalra, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alberta |
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Name:
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Ming Chan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alberta |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- El Escorial Classification of laboratory supported probable, probable,or definite ALS
- Age 18 - 80 years,
- ALS symptoms for no more than 3 years,
- FVC greater than or equal to 60% predicted,
- Riluzole naïve or have been on a stable dose of Riluzole for at least 2 months,
- Patients must have the ability to attend monthly study visits in Edmonton or Calgary,
Alberta
Exclusion Criteria:
- Presence of significant sensory abnormalities, dementia, other neurologic diseases,
uncompensated medical illness and psychiatric illness
- Female patients who are breastfeeding
- Use of concurrent investigational drugs,
- Patient unlikely to comply with study requirements
- Poor adherence to study protocol during run-in phase
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: Memantine
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Primary Outcome(s)
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Forced vital capacity (FVC)
[Time Frame: No]
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ALS Functional Rating Scale-Revised (ALSFRS-R)
[Time Frame: No]
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Addenbrooke Cognitive Examination (ACE)
[Time Frame: No]
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Manual Muscle Testing (MMT)
[Time Frame: No]
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Secondary Outcome(s)
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Motor unit number estimates of hand and foot muscles
[Time Frame: No]
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N-acetylaspartate in the motor cortex
[Time Frame: No]
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Secondary ID(s)
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1204
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EB2006ALS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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