Trial | NCT02434549  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    16
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 Started
Aug 31
2015
Primary Completion
Jan 26
2018
Study Completion
Oct 05
2018
Last Update
Oct 09
2018

Drug Dysport®

Intramuscular injections in spastic muscle with regional muscle-related pain

  • Other names: AbobotulinumtoxinA

Drug Normal saline

Intramuscular injections in spastic muscle with regional muscle-related pain

  • Other names: 0.9 % NaCl, Physiological saline

Botulinum toxin-A (Dysport®) Active Comparator

Intramuscular injections of Botulinum toxin-A in spastic muscles with regional muscle-related pain

Normal saline Placebo Comparator

Intramuscular injections of normal saline solution in spastic muscles with regional muscle-related pain

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.
No Results Posted