Effect of Riluzole as a Symptomatic Approach in Patients With Chronic Cerebellar Ataxia
NCT ID: NCT00202397
Last Updated: 2024-12-02
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
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2005-06-30
2008-08-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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2
placebo bid for 8 weeks
placebo
capsule-shaped tablet bid for 8 weeks
1
Riluzole, capsule-shaped 50 mg tablets bid for 8 weeks
Riluzole
capsule-shaped 50 mg tablets bid for 8 weeks
Interventions
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Riluzole
capsule-shaped 50 mg tablets bid for 8 weeks
placebo
capsule-shaped tablet bid for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Acute cerebellar ataxia
* Use of other drugs for chronic ataxia
* Serious concomitant illnesses (cardiac arrhythmias, haematological and hepatic diseases)
* Pregnancy or breast feeding
18 Years
80 Years
ALL
No
Sponsors
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S. Andrea Hospital
OTHER
Responsible Party
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Giovanni Ristori
MD, PhD
Principal Investigators
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Marco Salvetti, Assoc. Prof
Role: STUDY_DIRECTOR
S.Andrea Hospital, University of Rome "La Sapienza"
Giovanni Ristori, MD
Role: PRINCIPAL_INVESTIGATOR
University of Roma La Sapienza
Locations
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S.Andrea Hospital - University of Rome "La Sapienza"
Rome, , Italy
Countries
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References
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Shakkottai VG, Chou CH, Oddo S, Sailer CA, Knaus HG, Gutman GA, Barish ME, LaFerla FM, Chandy KG. Enhanced neuronal excitability in the absence of neurodegeneration induces cerebellar ataxia. J Clin Invest. 2004 Feb;113(4):582-90. doi: 10.1172/JCI20216.
Aizenman CD, Huang EJ, Linden DJ. Morphological correlates of intrinsic electrical excitability in neurons of the deep cerebellar nuclei. J Neurophysiol. 2003 Apr;89(4):1738-47. doi: 10.1152/jn.01043.2002.
Raman IM, Gustafson AE, Padgett D. Ionic currents and spontaneous firing in neurons isolated from the cerebellar nuclei. J Neurosci. 2000 Dec 15;20(24):9004-16. doi: 10.1523/JNEUROSCI.20-24-09004.2000.
Cao YJ, Dreixler JC, Couey JJ, Houamed KM. Modulation of recombinant and native neuronal SK channels by the neuroprotective drug riluzole. Eur J Pharmacol. 2002 Aug 2;449(1-2):47-54. doi: 10.1016/s0014-2999(02)01987-8.
Doble A. The pharmacology and mechanism of action of riluzole. Neurology. 1996 Dec;47(6 Suppl 4):S233-41. doi: 10.1212/wnl.47.6_suppl_4.233s.
Trouillas P, Takayanagi T, Hallett M, Currier RD, Subramony SH, Wessel K, Bryer A, Diener HC, Massaquoi S, Gomez CM, Coutinho P, Ben Hamida M, Campanella G, Filla A, Schut L, Timann D, Honnorat J, Nighoghossian N, Manyam B. International Cooperative Ataxia Rating Scale for pharmacological assessment of the cerebellar syndrome. The Ataxia Neuropharmacology Committee of the World Federation of Neurology. J Neurol Sci. 1997 Feb 12;145(2):205-11. doi: 10.1016/s0022-510x(96)00231-6.
Related Links
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sponsor site
Other Identifiers
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NEU - RLZ - 05
Identifier Type: -
Identifier Source: org_study_id