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

Primary Purpose

Pain, Cerebral Palsy, Spastic

Status
Terminated
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Dysport®
Normal saline
Sponsored by
Kristina Tedroff
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Randomized Controlled Trial, Placebo Controlled, Double Blinded, Botulinum Toxin Type A, Adults, Pain, Spasticity, Cerebral Palsy, Spastic, Dysport

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Rehabilitation Medicine at Danderyd Hospital AB
  • Astrid Lindgren's Children's Hospital at Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Botulinum toxin-A (Dysport®)

Normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain intensity
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

Use of other analgesic 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
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.

Full Information

First Posted
April 30, 2015
Last Updated
October 6, 2018
Sponsor
Kristina Tedroff
Collaborators
Danderyd Hospital, Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02434549
Brief Title
Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial
Acronym
BATCP
Official Title
Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Based on efficacy results from interim analysis
Study Start Date
August 2015 (undefined)
Primary Completion Date
January 26, 2018 (Actual)
Study Completion Date
October 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kristina Tedroff
Collaborators
Danderyd Hospital, Karolinska University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Cerebral Palsy, Spastic
Keywords
Randomized Controlled Trial, Placebo Controlled, Double Blinded, Botulinum Toxin Type A, Adults, Pain, Spasticity, Cerebral Palsy, Spastic, Dysport

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum toxin-A (Dysport®)
Arm Type
Active Comparator
Arm Description
Intramuscular injections of Botulinum toxin-A in spastic muscles with regional muscle-related pain
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Intramuscular injections of normal saline solution in spastic muscles with regional muscle-related pain
Intervention Type
Drug
Intervention Name(s)
Dysport®
Other Intervention Name(s)
AbobotulinumtoxinA
Intervention Description
Intramuscular injections in spastic muscle with regional muscle-related pain
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
0.9 % NaCl, Physiological saline
Intervention Description
Intramuscular injections in spastic muscle with regional muscle-related pain
Primary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
Six weeks after treatment
Secondary Outcome Measure Information:
Title
Use of other analgesic treatment
Description
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.
Time Frame
Six weeks after treatment
Title
Pain interference
Description
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.
Time Frame
Six weeks after treatment
Other Pre-specified Outcome Measures:
Title
HRQoL (Health-Related Quality of Life)
Description
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)
Time Frame
Six weeks after treatment
Title
Global Impression of Change
Description
Proportion of responders at Visit 3 (six weeks after treatment) in the Global Impression of Change Scale (PGIC) derived as at least "Minimally improved".
Time Frame
Six weeks after treatment
Title
Fatigue Severity Scale
Description
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.
Time Frame
Six weeks after treatment
Title
Spasticity
Description
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)
Time Frame
Six weeks after treatment
Title
Range of Motion
Description
Proportion of responders at Visit 3 (six weeks after treatment) derived as improvement in passive joint range of motion (ROM) ≥ 10 degrees.
Time Frame
Six weeks after treatment
Title
Adverse Events
Description
Frequency of adverse events
Time Frame
Six weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Tedroff, MD, PhD
Organizational Affiliation
Associate Professor, Department of Women's and Children's Health, Karolinska Institutet. Senior Consultant Physician, Astrid Lindgren's Children's Hospital, Stockholm, Sweden.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation Medicine at Danderyd Hospital AB
City
Danderyd
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Astrid Lindgren's Children's Hospital at Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
34484101
Citation
Jacobson D, Lowing K, Kullander K, Rydh BM, Tedroff K. A First Clinical Trial on Botulinum Toxin-A for Chronic Muscle-Related Pain in Cerebral Palsy. Front Neurol. 2021 Aug 16;12:696218. doi: 10.3389/fneur.2021.696218. eCollection 2021.
Results Reference
derived

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

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