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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-10-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain Cerebral Palsy, Spastic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Botulinum toxin-A (Dysport®)

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

Group Type ACTIVE_COMPARATOR

Dysport®

Intervention Type DRUG

Intramuscular injections in spastic muscle with regional muscle-related pain

Normal saline

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Intramuscular injections in spastic muscle with regional muscle-related pain

Interventions

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Dysport®

Intramuscular injections in spastic muscle with regional muscle-related pain

Intervention Type DRUG

Normal saline

Intramuscular injections in spastic muscle with regional muscle-related pain

Intervention Type DRUG

Other Intervention Names

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AbobotulinumtoxinA 0.9 % NaCl Physiological saline

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Kristina Tedroff

MD, PhD. Associate Professor. Senior Consultant Physician.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kristina Tedroff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Department of Women's and Children's Health, Karolinska Institutet. Senior Consultant Physician, Astrid Lindgren's Children's Hospital, Stockholm, Sweden.