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Clinical Trials/ACTRN12616000366459
ACTRN12616000366459CompletedPhase 3

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

Murdoch Childrens Research Institute0 sites13 target enrollmentStarted: March 22, 2016Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
13
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Non-randomised trial
Primary Purpose
Treatment
Masking
Open (masking not used)

Eligibility Criteria

Ages
6 Years to 18 Years (—)
Sex
All

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

Investigators

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