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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00202397 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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Effect of Riluzole as a Symptomatic Approach in Patients With Chronic Cerebellar Ataxia
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Scientific title:
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Phase 2 Study of Riluzole Effects on Patients With Chronic Cerebellar Ataxia |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00202397 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Italy
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Contacts
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Name:
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Marco Salvetti, Assoc. Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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S.Andrea Hospital, University of Rome "La Sapienza" |
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Name:
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Giovanni Ristori, 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 Roma La Sapienza |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with cerebellar degeneration (heredoataxias, sporadic idiopathic ataxia,
multiple system atrophy type C)
- Patients who meet McDonald criteria for probable or definite multiple sclerosis (MS)
with chronic cerebellar ataxia (not acute cerebellar ataxia due to relapse)
- Age between 18 and 80 years
Exclusion Criteria:
- Ataxia due to other diseases
- Acute cerebellar ataxia
- Use of other drugs for chronic ataxia
- Serious concomitant illnesses (cardiac arrhythmias, haematological and hepatic
diseases)
- Pregnancy or breast feeding
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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Cerebellar Ataxia
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Hereditary Ataxia
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Multiple Sclerosis
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Intervention(s)
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Drug: Riluzole
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Other: placebo
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Primary Outcome(s)
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The International Cooperative Ataxia Rating Scale (ICARS) total scores and subscores (oculomotor, kinetic, postural, speech), comparing the three time points in the treated versus placebo group
[Time Frame: pre-treatment, after 4 weeks of treatment and at the end of the study]
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Secondary ID(s)
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NEU - RLZ - 05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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