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

Phase 2

Terminated

• Conditions: Pain; Cerebral Palsy, Spastic
• Interventions: Drug: Dysport®; Drug: Normal saline

• Registration Number: NCT02434549
• Lead Sponsor: Kristina Tedroff

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-30
• Study First Submitted QC: 2015-04-30
• Study First Posted: 2015-05-05
• Study Start: 2015-08
• Primary Completion: 2018-01-26
• Status Verified: 2018-10
• Study Completion: 2018-10-05
• Last Update Submitted: 2018-10-06
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum toxin-A (Dysport®)	Dysport®	Intramuscular injections of Botulinum toxin-A in spastic muscles with regional muscle-related pain
Normal saline	Normal saline	Intramuscular injections of normal saline solution in spastic muscles with regional muscle-related pain

Primary Outcome Measures

Name	Time	Method
Pain intensity	Six weeks after treatment	Proportion of responders derived as reduction of intensity of pain of ≥2 points on the Numerical Rating Scale (NRS) at Visit 3 (six weeks after treatment) compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Use of other analgesic treatment	Six weeks after treatment	Categories of change in the use of analgesic treatments, derived as Increase, No change, or Decrease at Visit 3 (six weeks after treatment), compared to baseline.
Pain interference	Six weeks after treatment	Proportion of responders derived as a reduction in mean interference score of ≥1 on the Brief Pain Inventory (BPI-SF) at Visit 3 (six weeks after treatment) compared to baseline.

Trial Locations

Locations (2)

Astrid Lindgren's Children's Hospital at Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Department of Rehabilitation Medicine at Danderyd Hospital AB; 🇸🇪 Danderyd, Sweden