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Clinical Trials/EUCTR2008-000833-23-IT
EUCTR2008-000833-23-IT
Active, Not Recruiting
N/A

Efficacy evaluation of oral baclofen treatment versus intrathecal baclofen in children with dystonic cerebral palsy - Oral/intrathecal therapy in children with dystonia

AZIENDA OSPEDALIERA ISTITUTI CLINICI DI PERFEZIONAMENTO DI MILANO0 sitesNovember 6, 2008
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ConditionsDystonic or spastic dystonic cerebral palsyMedDRA version: 9.1Level: SOCClassification code 10029205MedDRA version: 9.1Level: PTClassification code 10008129MedDRA version: 9.1Level: LLTClassification code 10021740
DrugsLIORESAL*INTRATEC 1F 10MG 5MLLIORESAL*50CPR 25MG

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dystonic or spastic dystonic cerebral palsy
Sponsor
AZIENDA OSPEDALIERA ISTITUTI CLINICI DI PERFEZIONAMENTO DI MILANO
Status
Active, Not Recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 6, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AZIENDA OSPEDALIERA ISTITUTI CLINICI DI PERFEZIONAMENTO DI MILANO

Eligibility Criteria

Inclusion Criteria

  • •Severe dystonia in children with cerebral palsy
  • •Patients responders to baclofen bolus test
  • •Maximum age 16 years
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) no
  • •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

  • •Patients for which there is a controindication for baclofen therapy
  • •Children already treated with any anti\-dystonic drugs at the time of the bolous test and children with previous surgery

Outcomes

Primary Outcomes

Not specified

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