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Sponsors and Collaborators: |
S. Andrea Hospital CENTERS |
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Information provided by: | S. Andrea Hospital |
ClinicalTrials.gov Identifier: | NCT00202397 |
Cerebellar disorders are often disabling and symptomatic therapies are limited to few options that are partially effective. It seems therefore appropriate to search for additional approaches. Purkinje cells are the sole output of the cerebellar cortex: they project inhibitory signals to the deep cerebellar nuclei (DCN), which have a critical role in cerebellar function and motor performance. DCN neurons fire spontaneously in the absence of synaptic input from Purkinje neurons and modulation of the DCN response by Purkinje input is believed to be responsible for coordination of movement. Recent evidences support the notion that an increase in DCN excitability may be an important step in the development of cerebellar ataxia and point to the underlying molecular mechanisms: the inhibition of small-conductance calcium-activated potassium (SK) channels, that causes an increase of the firing frequency in DCN, correlates with cerebellar ataxia.
The rationale of the present project is that SK channel openers, such as riluzole, may have a beneficial effect on cerebellar ataxia. The researchers propose to perform a pilot study investigating safety and efficacy of riluzole, an approved treatment for amyotrophic lateral sclerosis, as a symptomatic approach in patients with chronic cerebellar ataxia.
Condition | Intervention | Phase |
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Hereditary Ataxia Multiple Sclerosis Cerebellar Ataxia |
Drug: Riluzole Other: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Study of Riluzole Effects on Patients With Chronic Cerebellar Ataxia |
Enrollment: | 40 |
Study Start Date: | June 2005 |
Study Completion Date: | August 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Placebo Comparator
placebo bid for 8 weeks
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Other: placebo
capsule-shaped tablet bid for 8 weeks
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1: Experimental
Riluzole, capsule-shaped 50 mg tablets bid for 8 weeks
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Drug: Riluzole
capsule-shaped 50 mg tablets bid for 8 weeks
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Forty patients with chronic cerebellar ataxia will be enrolled in a double-bind, randomized, placebo-controlled trial. By central randomisation, patients will take 50 mg of riluzole or placebo twice daily for 8 weeks. Electrocardiogram routine laboratory tests and pregnancy tests will be performed before drug administration, after 4 weeks of treatment and at the end of the study (after 8 weeks of treatment).
At the same time points the International Cooperative Ataxia Rating Scale (ICARS) for pharmacological assessment of the cerebellar syndrome will be administered to the two groups (riluzole and placebo) of patients. To guarantee the evaluation of the results in blind conditions, the neurologists who will evaluate the ICARS scores will be different from those who will deal with randomisation and follow-up of patients.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
S.Andrea Hospital - University of Rome "La Sapienza" | |
Rome, Italy, 00100 |
Study Director: | Marco Salvetti, Assoc. Prof | S.Andrea Hospital, University of Rome "La Sapienza" |
Principal Investigator: | Giovanni Ristori, MD | University of Roma La Sapienza |
Responsible Party: | S.Andrea Hospital - II Faculty of Medicine, "Sapienza" University of Rome ( Giovanni Ristori ) |
Study ID Numbers: | NEU - RLZ - 05 |
Study First Received: | September 12, 2005 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00202397 History of Changes |
Health Authority: | Italy: Ministry of Health |
cerebellar ataxia deep cerebellar nuclei (DCN) small-conductance calcium-activated potassium(SK)channels |
riluzole Sporadic ataxia Multiple system atrophy type C |
Neurotransmitter Agents Spinal Cord Diseases Brain Diseases Neurodegenerative Diseases Neuroprotective Agents Signs and Symptoms Multiple Sclerosis Heredodegenerative Disorders, Nervous System Ataxia Spinocerebellar Degenerations Autoimmune Diseases of the Nervous System Riluzole Excitatory Amino Acids Autoimmune Diseases |
Demyelinating Diseases Central Nervous System Diseases Sclerosis Dyskinesias Hereditary Ataxia Cerebellar Ataxia Calcium, Dietary Multiple System Atrophy Genetic Diseases, Inborn Neurologic Manifestations Demyelinating Autoimmune Diseases, CNS Atrophy Cerebellar Diseases Anticonvulsants |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Spinal Cord Diseases Physiological Effects of Drugs Excitatory Amino Acid Agents Brain Diseases Neurodegenerative Diseases Neuroprotective Agents Signs and Symptoms Multiple Sclerosis Heredodegenerative Disorders, Nervous System Pathologic Processes Therapeutic Uses Ataxia Spinocerebellar Degenerations |
Autoimmune Diseases of the Nervous System Excitatory Amino Acid Antagonists Riluzole Autoimmune Diseases Demyelinating Diseases Immune System Diseases Nervous System Diseases Central Nervous System Diseases Sclerosis Protective Agents Dyskinesias Pharmacologic Actions Cerebellar Ataxia Genetic Diseases, Inborn Neurologic Manifestations |