Gabapentin as symptomatic therapy of cerebellar ataxia in degenerative and inflammatory CNS-disease

Phase 4

Recruiting

Conditions: G11.2
G31.9
G35
Late-onset cerebellar ataxia
Degenerative disease of nervous system, unspecified
Multiple sclerosis

Registration Number: DRKS00000269

Lead Sponsor: FakultätsleitungCharité - Universitätsmedizin Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 72

Inclusion Criteria

patient written consent
- age 18-75 years
- cerebellar ataxia in patients with multiple sclerosis since at least 3 months, in patients with degenerative cerebellar ataxia since at least 1 year
- for women before menopause: negative pregrancy test and highly effective contraception method applied

Exclusion Criteria

- pregnancy and lactation
- all contraindications against the drug or the placebo ingredients
- medication with morphin, pregabaline, naproxen
- gabapentine-treatment within the last month
- forced hospitalization
- alcohol abuse within the past 10 years
- acute or chronic pancreatitis
- renal insufficiency
- liver insufficiency
- unability to walk even with support
- participation in another treatment trial up to 2 months before and during the participation in GABATAX

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SARA ataxia scale (standardised clinical examination): visit 1 (no medication yet) and visit 4 (after 7 weeks of therapy)

Secondary Outcome Measures

Name	Time	Method
nited Huntington's Disease Rating Scale (UHDRS; questionnaire) Part IV: visit 1, visit 3 and 4 \|\| gain of VOR during VOR-Suppression test, velocity of slow phase of gaze-evoked nystagmus, measured by infrared-oculography: visit 1 and 4 \|\| CCFS - Cerebellar Composite Functional Scale, functional clinical test: visit 1,3 and 4