Botulinum toxin-A as a treatment for chronic muscle-related pain in adults with spastic cerebral palsy: a randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000095-10-SE

Enrollment

Registered

2015-02-16

Start date

2015-03-30

Completion date

Unknown

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spastic cerebral palsy

Interventions

Trade Name: Dysport Pharmaceutical Form: Powder for injection INN or Proposed INN: BOTULINUM TOXIN A Other descriptive name: BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX Concentration unit: IU internat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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. • 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. ;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	—

Measure

Time frame

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. • 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. ;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

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Secondary

Measure	Time frame
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. • 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. ;Timepoint(s) of evaluation of this end point: Baseline and ca six weeks after treatment	—

Measure

Time frame

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. • 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. ;Timepoint(s) of evaluation of this end point: Baseline and ca six weeks after treatment

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Countries

Sweden

Contacts

Public ContactKarolinska Institutet

Karolinska Institutet

+468524 800 00

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026