PainPhase 2BATCPNCT02434549
Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial
A Phase 2 study testing Dysport® and Normal saline in people with Pain and Cerebral Palsy, Spastic, run by Kristina Tedroff at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Cerebral Palsy, Spastic
- What is being tested?
- Dysport® and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesSweden
- Study dates
- Aug 2015to 5 Oct 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Department of Rehabilitation Medicine at Danderyd Hospital AB
Danderyd, 182 88
Astrid Lindgren's Children's Hospital at Karolinska University Hospital
Stockholm, 171 76
About this study
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.
- Conditions
- Pain, Cerebral Palsy, Spastic
- Being tested
- Dysport®, Normal saline
- Keywords
- Randomized Controlled Trial, Placebo Controlled, Double Blinded, Botulinum Toxin Type A, Adults, Pain, Spasticity, Cerebral Palsy, Spastic, Dysport
- Medical subject headings
- Pain, Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dysport®Drug
Also called AbobotulinumtoxinA
Intramuscular injections in spastic muscle with regional muscle-related pain
Normal salineDrug
Also called 0.9 % NaCl, Physiological saline
Intramuscular injections in spastic muscle with regional muscle-related pain
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin-A (Dysport®) | Active comparator | Intramuscular injections of Botulinum toxin-A in spastic muscles with regional muscle-related pain Receives: Drug: Dysport® |
| Normal saline | Placebo comparator | Intramuscular injections of normal saline solution in spastic muscles with regional muscle-related pain Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six weeks after treatment
Secondary outcomes (2)
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.
Measured: Six weeks after treatment
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.
Measured: Six weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startAug 2015
- Primary completion26 Jan 2018
- Study completion5 Oct 2018
Why it stopped: Based on efficacy results from interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristina Tedroff
- Sponsor type
- University, hospital or other
- Collaborators
- Danderyd Hospital, Karolinska University Hospital
- Responsible party
- Sponsor-investigator, Kristina Tedroff, Karolinska Institutet
- Investigators
- Kristina Tedroff, MD, PhD, 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434549
- Sponsor's protocol ID
- BATCP
- Acronym
- BATCP
- Status last verified
- Oct 2018
- First submitted
- 30 Apr 2015
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34484101
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02434549
- Acronym / sponsor ID
- BATCP / BATCP
- Conditions
- Pain, Cerebral Palsy, Spastic
- Keywords
- Randomized Controlled Trial, Placebo Controlled, Double Blinded, Botulinum Toxin Type A, Adults, Pain, Spasticity, Cerebral Palsy, Spastic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on efficacy results from interim analysis
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kristina TedroffUniversity, hospital or other
- Collaborators
- Danderyd Hospital, Karolinska University Hospital
- Study start
- Aug 2015
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 5 Oct 2018 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin-A (Dysport®) | Active comparator | Drug: Dysport®Intramuscular injections of Botulinum toxin-A in spastic muscles with regional muscle-related pain |
| Normal saline | Placebo comparator | Drug: Normal salineIntramuscular injections of normal saline solution in spastic muscles with regional muscle-related pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dysport®Also: AbobotulinumtoxinAIntramuscular injections in spastic muscle with regional muscle-related pain | Drug | Botulinum toxin-A (Dysport®) |
| Normal salineAlso: 0.9 % NaCl, Physiological salineIntramuscular injections in spastic muscle with regional muscle-related pain | Drug | Normal saline |
Primary outcome
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.
2 secondary outcomes
Use of other analgesic treatment
Time frame: Six weeks after treatment
Pain interference
Time frame: Six weeks after treatment
Results and safety
The study was stopped early (reason given: Based on efficacy results from interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 34484101Jacobson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Tedroff, MD, PhD 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dysport® and Normal saline in people with Pain and Cerebral Palsy, Spastic, run by Kristina Tedroff at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Based on efficacy results from interim analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Six weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02434549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.