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

Arm | Intervention/treatment |
---|---|
Active Comparator: Botulinum toxin-A (Dysport®)
Intramuscular injections of Botulinum toxin-A in spastic muscles with regional muscle-related pain
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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
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Drug: Normal saline
Intramuscular injections in spastic muscle with regional muscle-related pain
Other Names:
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- 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.
- 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.
- 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.
- 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)
- 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".
- 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.
- 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)
- 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.
- Adverse Events [ Time Frame: Six weeks after treatment ]Frequency of adverse events

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
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. |
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 |
Randomized Controlled Trial Placebo Controlled Double Blinded Botulinum Toxin Type A Adults |
Pain Spasticity Cerebral Palsy, Spastic Dysport |
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 |