Trial document




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  DRKS00000269

Trial Description

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Title

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

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Trial Acronym

GABATAX

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this study we will examine, if patients with coordination deficits because of cerebellar ataxia suffering from neurodegenerative disease or from multiple sclerosis benefit from a therapy with the drug Gabapentin.

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Brief Summary in Scientific Language

double-blind, placebo-controlled clinical trial with parallel groups to examine the effect of gabapentine on the symptoms of cerebellar ataxia in patients with neurodegenerative cerebellar disease and patients with multiple sclerosis.

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Organizational Data

  •   DRKS00000269
  •   2010/04/07
  •   [---]*
  •   yes
  •   Approved
  •   ZS EK 11 425/09, Ethik-Kommission des Landes Berlin
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Secondary IDs

  •   U1111-1112-5612 
  •   2008-005167-33 
  •   GABATAX 1210 
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Health Condition or Problem studied

  •   G11.2 -  Late-onset cerebellar ataxia
  •   G31.9 -  Degenerative disease of nervous system, unspecified
  •   G35 -  Multiple sclerosis
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Interventions/Observational Groups

  •   Verum therapy: gabapentine 600-1800mg daily for 4 weeks after a 3 week dose-in phase
  •   Placebo therapy arm: 2-6 placebo capsules daily for 4 weeks after 3 week dosing-in phase
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
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  •   Placebo
  •   Treatment
  •   Parallel
  •   IV
  •   [---]*
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Primary Outcome

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

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Secondary Outcome

United 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/08/27
  •   72
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional 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

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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

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Addresses

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    • Fakultätsleitung Charité - Universitätsmedizin Berlin
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Klinik und Poliklinik für Neurologie Charité - Universitätsmedizin Berlin
    • Ms.  Dr. med.  Sarah  Stricker 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Ataxie-Ambulanz Neurologische Poliklinik Charité Universitätsmedizin Berlin
    • Ms.  Dr. med.  Sarah  Stricker 
    • Charitépl. 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • DFG
    • Deutsche Forschungsgemeinschaft 
    • Kennedyallee 40
    • 53170  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.