Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial

• Status: Terminated
• Trial end date: 2018-10-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kristina Tedroff
• Collaborators: Danderyd Hospital; Department of Rehabilitation Medicine, Danderyd Hospital AB.; Karolinska Trial Alliance, Karolinska University Hospital Huddinge.; Karolinska University Hospital
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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.