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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-005414-40-IT
Enrollment
Unknown
Registered
2007-11-28
Start date
2007-12-21
Completion date
Unknown
Last updated
2012-04-03

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

Conditions

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

Interventions

Trade Name: KEPPRA Pharmaceutical Form: Coated tablet INN or Proposed INN: Levetiracetam Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500-

Sponsors

AZIENDA SANITARIA N. 3 GENOVESE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) male and female aged ≥ 18 years old =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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;

Design outcomes

Primary

MeasureTime frame
Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): Variation to nine-hole peg test—

Countries

Italy

Outcome results

None listed

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