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Prospective, open-label, non-randomized, single-arm, dose titration study to investigate the efficacy and safety of IncobotulinumtoxinA in children deemed to require a total body dose up to 22U/kg (maximum dose 550U) during the study period for the treatment of upper and lower limb spasticity due to cerebral palsy
EU CTIS ID: 2024-518447-38-00
What this study is testing
to investigate the efficacy of IncobotulinumtoxinA in the treatment of both BoNT-A naïve and pretreated children for upper and lower limb spasticity using a dose titration approach over three injection cycles, with a flexible observation period after injection of 12 to 20 weeks and a total duration of exposure up to 60 weeks
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Children (female or male) aged 2 to 17 years
- Patients with upper and lower limb spasticity due to cerebral palsy
- Gross Motor Function Classification System (GMFCS) from Level II to Level V
- Selected target clinical pattern diagnosed by a qualified health care professional
- Focal spasticity scored at least 2 points on the Ashworth scale (AS) in the joints associate with the selected target clinical pattern
- Patient deemed by the investigator to require a total body dose up to 22U/kg (maximum 550U) during the study period
You likely can't join if
- Participation in other trials
- BoNT-A treatment contraindicated
- Therapy with anticoagulants or other substances that could have an anticoagulant effect
- Girls of childbearing potential (defined as females post menarche)
- Presence of fixed contractures, or bony deformities of the affected limbs
- Previous treatment of spastic muscles with nerve phenolization
See the full eligibility criteria
- Children (female or male) aged 2 to 17 years
- Patients with upper and lower limb spasticity due to cerebral palsy
- Gross Motor Function Classification System (GMFCS) from Level II to Level V
- Selected target clinical pattern diagnosed by a qualified health care professional
- Focal spasticity scored at least 2 points on the Ashworth scale (AS) in the joints associate with the selected target clinical pattern
- Patient deemed by the investigator to require a total body dose up to 22U/kg (maximum 550U) during the study period
- In the case of children pretreated with BoNT-A, time from last injection at least 5 months
- Informed consent signed by parents or legal guardian
- Participation in other trials
- BoNT-A treatment contraindicated
- Therapy with anticoagulants or other substances that could have an anticoagulant effect
- Girls of childbearing potential (defined as females post menarche)
- Presence of fixed contractures, or bony deformities of the affected limbs
- Previous treatment of spastic muscles with nerve phenolization
- Other neurological or orthopedic conditions involving the affected limbs
- institutionalized patients
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.