Botulinum toxin-A as a treatment for chronic muscle-related pain in adults with spastic cerebral palsy: a randomized controlled trial.
- Conditions
- Spastic cerebral palsyTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-000095-10-SE
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
- Age = 18 years.
- Spastic Cerebral palsy, according to SCPE guidelines 1
- Chronic pain, with pain localization related to regional spastic muscle. Chronic pain defined as:
* Recurring regional pain for at least three (3) months.
* Pain intensity on average for the last 24 hours =3 on Numerical Rating Scale.
- Signed Informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
For reasons of safety:
- Allergy/hypersensitivity to Dysport® or any of its components.
- Pregnancy. All women not passed menopause or not previously surgically sterilized, will need to perform a urine pregnancy test at Visit 2, before treatment.
- Women who breastfeed their children.
For reasons of study consistency:
- Treatment with BoNT-A within the last 5 months.
- If there has been dose changes in any muscle-tone altering medication within two (2) weeks of Screening visit.
- A clear degenerative cause behind the pain as elucidated by the clinical examination (i.e. history of osteoarthritis).
- Intellectual disability and/or communication impairment that disable the individual from answering the questionnaires and giving informed consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate if intramuscular injections with Botulinum toxin-A is effective in reducing muscle-related chronic pain in adults with spastic cerebral palsy, compared to placebo control. ;Secondary Objective: • To evaluate if intramuscular injections with Botulinum toxin-A leads to reduced need for analgesics in adults with spastic cerebral palsy.<br>• To evaluate if intramuscular injections with Botulinum toxin-A is effective in reducing interference with activities of daily living (ADL) associated with pain in adults with spastic cerebral palsy.<br>;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: Baseline and ca six weeks after treatment <br><br><br><br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • 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.<br><br>• Proportion of responders derived as a reduction in mean interference score of =1 on the Brief Pain Inventory (BPI) at Visit 3 (six weeks after treatment) compared to baseline.<br>;Timepoint(s) of evaluation of this end point: Baseline and ca six weeks after treatment