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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)

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ClinicalTrials.gov Identifier: NCT02434549
Recruitment Status : Terminated (Based on efficacy results from interim analysis)
First Posted : May 5, 2015
Last Update Posted : October 9, 2018
Sponsor:
Collaborators:
Danderyd Hospital
Karolinska University Hospital
Information provided by (Responsible Party):
Kristina Tedroff, Karolinska Institutet

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Cerebral Palsy, Spastic Drug: Dysport® Drug: Normal saline Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial
Study Start Date : August 2015
Actual Primary Completion Date : January 26, 2018
Actual Study Completion Date : October 5, 2018

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Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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)

  2. 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".

  3. 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.

  4. 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)

  5. 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.

  6. Adverse Events [ Time Frame: Six weeks after treatment ]
    Frequency of adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434549


Locations
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Sweden
Department of Rehabilitation Medicine at Danderyd Hospital AB
Danderyd, Sweden, 182 88
Astrid Lindgren's Children's Hospital at Karolinska University Hospital
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Kristina Tedroff
Danderyd Hospital
Karolinska University Hospital
Investigators
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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.
More Information
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Responsible Party: Kristina Tedroff, MD, PhD. Associate Professor. Senior Consultant Physician., Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02434549    
Other Study ID Numbers: BATCP
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Keywords provided by Kristina Tedroff, Karolinska Institutet:
Randomized Controlled Trial
Placebo Controlled
Double Blinded
Botulinum Toxin Type A
Adults
 Pain
Spasticity
Cerebral Palsy, Spastic
Dysport
Additional relevant MeSH terms:
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Muscle Spasticity
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
 Muscle Hypertonia
Neuromuscular Manifestations
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs