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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005167-33-DE

Enrollment

Unknown

Registered

2010-03-16

Start date

2010-03-29

Completion date

Unknown

Last updated

2016-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

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 co

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Effect of gabapentine versus placebo on ataxia after 7 weeks of treatment measured with cllinical ataxia rating scale (SARA);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;Primary end point(s): change in SARA scale between week 7 and 0	—

Measure

Time frame

Main Objective: Effect of gabapentine versus placebo on ataxia after 7 weeks of treatment measured with cllinical ataxia rating scale (SARA);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;Primary end point(s): change in SARA scale between week 7 and 0

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026