Effect of gabapentine as symptomatic therapy for cerebellar ataxia in degenerative and inflammatory CNS-disease

INTERVENTION: Trade Name: Neurontin 300 mg hard capsule Product Name: gabapentine 300mg Product Code: GBP Pharmaceutical Form: Capsule, hard INN or Proposed INN: Gabapentin CAS Number: 60142‐96‐3 Current Sponsor code: 1210 Other descriptive name: GABAPENTIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Patients with cerebellar ataxia with coordination deficits in walking, upper and lower limb movements and oculomtoor coordination deficits are included in the trial. The cause of their atayia is either a degenerative CNS disease (36 patients) such as autosomal dominant Spinocerebellar Ataxia or sporadic ataxia with late onset or inflammatory CNS disease (Multiple Sclerosis; 36 patients). PRIMARY OUTCOME: Main Objective: Effect of gabapentine versus placebo on ataxia after 7 weeks of treatment measured with cllinical ataxia rating scale (SARA) Primary end point(s): change in SARA scale between week 7 and 0 Secondary Objective: 1) Effect of gabapentine versus placebo on oculomotor incoordination ind ataxia patiente after 7 weeks of treatment measured with video nystagmography; 2) Effect of gabapentine versus placebo on quality of life in ataxia patients by United Huntingtons disease rating scale (UHDRS) part IV including functional 9‐hole pegboard and click test INCLUSION CRITERIA: • patient written informed consent • age 18 ‐ 75 years • diagnosed with multiple sclerosis or hereditary spinocerebellar ataxia or late onset idiopathic cerebellar ataxia • ataxia since at least 3 months (multiple sclerosis) or 1 year (hereditary spinocerebellar ataxia and idiopathic late onset ataxia) • highly effective contraception for women (defined as Pearl index < 1) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range