E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with an established and stable Multiple Sclerosis (according to Poser criteria). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028245 |
E.1.2 | Term | Multiple sclerosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to evaluate the efficacy of Levetiracetam on cerebellar symptoms (through the 9 hole-peg test) in patients affected by Multiple Sclerosis. |
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E.2.2 | Secondary objectives of the trial |
1)evaluation of the efficacy of Levetiracetam on cerebellar symptoms through the Tremor severity scale 2) evaluation of the efficacy of Levetiracetam on cerebellar symptoms through the Ataxia scale 3) evaluation of the efficacy of Levetiracetam on cerebellar symptoms through the Tremor activity of daily living scale 4) evaluation of the efficacy of Levetiracetam on cerebellar symptoms through the Tremor-related handicap questionnaire 5) evaluation of the efficacy of Levetiracetam on cerebellar symptoms through VAS and CGI scales. 6) evaluation of the activity of Levetiracetam on cerebellar symptoms through a kinematic analisys. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1) male and female aged ≥ 18 years old < 65 years old; 2) Diagnosis of stable multiple sclerosis (according to Poser criteria), without relapses or a worsening major than 1 point at the EDSS (Expanded Disability Status Scale) in the last 3 months before 3) EDSS < than 7.5 at inclusion 4) Presence of kinetic-intention tremor (tremor will be assessed in 3 states of the arm: rest, posture, movement during a finger-noise-finger test) 5) SCRIPPS scale for sensory and motor system ≥ than 3 6) Ashworth scale < than 2 7) written informed consent |
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E.4 | Principal exclusion criteria |
1) prior exposure to Levetiracetam 2) hepatopathy acute and chronic; 3) renal and pancreatic insufficiency; 4) female subjects who are pregnant or lactating; sexually active women with childbearing potential who are not using a medically accepted birth control method. 5) patients with contraindication to levetiracetam and/or to pyrrolidine derivates use; 6) cerebrovascular disease; 7) subjects with a malignancy or with a history of malignancy within the past five years; |
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E.5 End points |
E.5.1 | Primary end point(s) |
Variation to nine-hole peg test |
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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 | No |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
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 | No |
E.8.1.6 | Cross over | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 | Information not present in EudraCT |
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
| |
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 | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |