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Clinical Trials/ACTRN12616000366459
ACTRN12616000366459
Completed
Phase 3

A pilot study of gabapentin for managing pain in children with dystonic cerebral palsy

Murdoch Childrens Research Institute0 sites13 target enrollmentMarch 22, 2016
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ConditionsDystonic cerebral palsyPhysical Medicine / Rehabilitation - Other physical medicine / rehabilitationAnaesthesiology - Pain managementNeurological - Other neurological disorders

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Dystonic cerebral palsy
Sponsor
Murdoch Childrens Research Institute
Enrollment
13
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 22, 2016
End Date
January 7, 2019
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\)Confirmation of dystonia after completion of the Hypertonicity Assessment Tool (HAT). Those children who have dystonia or a mixed diagnosis (spasticity and dystonia) will be eligible.
  • •2\)Severity of dystonia will be determined with the Barry Albright Dystonia (BAD) scale. Children with a score of 15 or higher on the BAD scale will be eligible.
  • •3\)Pain will be quantified using the Health Utilities Index 3 (HUI 3\). Those children scoring IV or V will be eligible.

Exclusion Criteria

  • •Children excluded from the study will be those who:
  • •1\.Are younger than 6 years because they will have more difficulty with reliably self\-reporting and will not be able to perform some of the quantitative measurements.
  • •2\.Are currently on gabapentin or have been on gabapentin in the previous 3 months
  • •3\.Have demonstrated hypersensitivity to gabapentin or the inactive ingredients in the capsules in the past
  • •4\.Are currently taking other medications that may interact with gabapentin (i.e. antacid, cimetidine, morphine, and opioids).
  • •5\.Pregnant female participants

Outcomes

Primary Outcomes

Not specified

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