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

Kristina Tedroff

Status and phase

Terminated

Phase 2

Conditions

Cerebral Palsy, Spastic

Pain

Treatments

Drug: Normal saline

Drug: Dysport®

Study type

Interventional

Funder types

Other

Identifiers

NCT02434549

BATCP

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.