Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial
TerminatedPhase 2NCT02434549
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of this double-blinded, placebo-controlled study is to test if treatment with Botulinum toxin-A is effective in reducing chronic muscle-related pain in adults with spastic cerebral palsy.
Study details
- Official title
- Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial
- Conditions
- Pain
- Cerebral Palsy, Spastic
- Interventions
- Drug: Dysport®
- Drug: Normal saline
- Sponsor
- Kristina Tedroff
- Collaborators
- Danderyd Hospital; Karolinska University Hospital
- Organization
- Karolinska Institutet
- Start date
- 2015-08
- Primary completion
- 2018-01-26
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Sweden
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age ≥ 18 years. * Spastic Cerebral Palsy. * Chronic pain, related to spastic muscle. Chronic pain defined as: 1)Recurring regional pain for at least three months AND 2)Pain intensity on average for the last 24 hours ≥3 on Numerical Rating Scale. * Signed Informed consent. Exclusion Criteria: * Allergy/hypersensitivity to Dysport® or any of its components. * Pregnancy. * Women who breastfeed their children. * Treatment with Botulinum toxin-A within the last five months. * If there has been dose changes in any muscle-tone altering medication within two weeks of Visit 1. * A clear degenerative cause behind the pain as elucidated by the clinical examination (e.g. history of osteoarthritis). * Intellectual disability and/or communication impairment that disable the individual from answering the questionnaires and giving informed consent.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02434549