E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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). |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Effect of gabapentine versus placebo on ataxia after 7 weeks of treatment measured with cllinical ataxia rating scale (SARA) |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
change in SARA scale between week 7 and 0 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last visit of last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |