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

October 6, 2018 updated by: Kristina Tedroff
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Danderyd, Sweden, 182 88
        • Department of Rehabilitation Medicine at Danderyd Hospital AB
      • Stockholm, Sweden, 171 76
        • Astrid Lindgren's Children's Hospital at Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Botulinum toxin-A (Dysport®)
Intramuscular injections of Botulinum toxin-A in spastic muscles with regional muscle-related pain
Drug: Dysport®
Intramuscular injections in spastic muscle with regional muscle-related pain
Other Names:
  • AbobotulinumtoxinA
Placebo Comparator: Normal saline
Intramuscular injections of normal saline solution in spastic muscles with regional muscle-related pain
Drug: Normal saline
Intramuscular injections in spastic muscle with regional muscle-related pain
Other Names:
  • 0.9 % NaCl
  • Physiological saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 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.
Six weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of other analgesic treatment
Time Frame: 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.
Six weeks after treatment
Pain interference
Time Frame: 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.
Six weeks after treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HRQoL (Health-Related Quality of Life)
Time Frame: Six weeks after treatment
Mean change at Visit 3 (six weeks after treatment) compared to baseline in the Short Form 36 v2 Health-related Quality of Life questionnaire (SF-36v2)
Six weeks after treatment
Global Impression of Change
Time Frame: Six weeks after treatment
Proportion of responders at Visit 3 (six weeks after treatment) in the Global Impression of Change Scale (PGIC) derived as at least "Minimally improved".
Six weeks after treatment
Fatigue Severity Scale
Time Frame: Six weeks after treatment
Proportion of responders at Visit 3 (six weeks after treatment) in the Fatigue Severity Scale (FSS) derived as a reduction in mean score of ≥1 point.
Six weeks after treatment
Spasticity
Time Frame: Six weeks after treatment
Proportion of responders at Visit 3 (six weeks after treatment) derived as achieving reduction of spasticity of >1 scale steps on the Modified Ashworth Scale (MAS)
Six weeks after treatment
Range of Motion
Time Frame: Six weeks after treatment
Proportion of responders at Visit 3 (six weeks after treatment) derived as improvement in passive joint range of motion (ROM) ≥ 10 degrees.
Six weeks after treatment
Adverse Events
Time Frame: Six weeks after treatment
Frequency of adverse events
Six weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kristina Tedroff

Collaborators

Karolinska University Hospital
Danderyd Hospital

Investigators

  • Principal Investigator: Kristina Tedroff, MD, PhD, Associate Professor, Department of Women's and Children's Health, Karolinska Institutet. Senior Consultant Physician, Astrid Lindgren's Children's Hospital, Stockholm, Sweden.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

January 26, 2018

Study Completion (Actual)

October 5, 2018

Study Registration Dates

First Submitted

April 30, 2015

First Submitted That Met QC Criteria

April 30, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 6, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BATCP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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