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

Phase 1

Conditions: 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).

Registration Number: EUCTR2008-005167-33-DE

Lead Sponsor: Charité University Medicine Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Exclusion Criteria

•pregnancy or lactation
•all contraindications against gabapentin
•medication with morphine, naproxen or pregabalin, interferon
•medication with gabapentin in past 3 months
•no consent for Speicherung und Weitergabe of pseudonymised clinical data
•forced hospitalization
Alcohol abuse in last 10 years
•Allergy against gabapentin or another ingredient of trial medication
•acute oder chronic pancreatitis
•kidney insufficience
•liver insufficience
•no ability to walk even with assistance
•fast disease progression (worsening in neurologic examination in last 2 months)
•participation in another treatment trial up to 2 months before and during the GABATAX trial