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Clinical Trials/EUCTR2010-019768-35-NL
EUCTR2010-019768-35-NL
Active, not recruiting
Phase 1

Intrathecal baclofen treatment in dystonic cerebral palsy: a randomized clinical trial - ITB in dystonic CP

Not provided0 sitesJanuary 8, 2013
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Conditionsdytonic cerebral palsyMedDRA version: 19.1Level: PTClassification code 10008129Term: Cerebral palsySystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Drugsbaclofen

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
dytonic cerebral palsy
Sponsor
Not provided
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 8, 2013
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Not provided

Eligibility Criteria

Inclusion Criteria

  • •Dystonic cerebral palsy
  • •GMFCS IV or V
  • •Lesions on MRI (cerebral white matter, basal ganglia, central cortex)
  • •Aged 4 to 25 years old
  • •Able and willing to complete study protocol
  • •Consensus about inclusion
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 32
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 3

Exclusion Criteria

  • •Contra\-indications for general anaesthesia
  • •Contra\-indications for baclofen
  • •Inadequate knowledge of Dutch language
  • •Deep brain stimulation
  • •Ventriculoperitoneal drain

Outcomes

Primary Outcomes

Not specified

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