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Clinical Trials/EUCTR2015-000095-10-SE
EUCTR2015-000095-10-SE
Active, Not Recruiting
Phase 1

Botulinum toxin-A as a treatment for chronic muscle-related pain in adults with spastic cerebral palsy: a randomized controlled trial.

Karolinska Institutet0 sites48 target enrollmentFebruary 16, 2015
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ConditionsSpastic cerebral palsyTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsDysport

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Spastic cerebral palsy
Sponsor
Karolinska Institutet
Enrollment
48
Status
Active, Not Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 16, 2015
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Age \= 18 years.
  • •\- Spastic Cerebral palsy, according to SCPE guidelines 1
  • •\- Chronic pain, with pain localization related to regional spastic muscle. Chronic pain defined as:
  • •\* Recurring regional pain for at least three (3\) months.
  • •\* Pain intensity on average for the last 24 hours \=3 on Numerical Rating Scale.
  • •\- Signed Informed consent.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 43

Exclusion Criteria

  • •For reasons of safety:
  • •\- Allergy/hypersensitivity to Dysport® or any of its components.
  • •\- Pregnancy. All women not passed menopause or not previously surgically sterilized, will need to perform a urine pregnancy test at Visit 2, before treatment.
  • •\- Women who breastfeed their children.
  • •For reasons of study consistency:
  • •\- Treatment with BoNT\-A within the last 5 months.
  • •\- If there has been dose changes in any muscle\-tone altering medication within two (2\) weeks of Screening visit.
  • •\- A clear degenerative cause behind the pain as elucidated by the clinical examination (i.e. history of osteoarthritis).
  • •\- Intellectual disability and/or communication impairment that disable the individual from answering the questionnaires and giving informed consent.

Outcomes

Primary Outcomes

Not specified

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