Efficacy and activity of levetiracetam on Multiple Sclerosis cerebellar symptoms: a multicenters double blind, randomized, placebo-controlled, cross over study - ND

• Conditions: Patients with an established and stable Multiple Sclerosis (according to Poser criteria).; MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis

• Registration Number: EUCTR2007-005414-40-IT
• Lead Sponsor: AZIENDA SANITARIA N. 3 GENOVESE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-28
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified