INcobotulinumtoxina in ChIldren Upper and Lower Limb sPasticITy (INCIPIT) (NCT05340439) | Clinical Trial Compass
UnknownPhase 2
INcobotulinumtoxina in ChIldren Upper and Lower Limb sPasticITy (INCIPIT)
30 participantsStarted 2022-06
Plain-language summary
Prospective, open-label, non-randomized, single-arm, dose titration, phase II study.
The study will consist of three injection cycles. In each, an injection visit is followed by an observation period of 12 to 20 weeks.
During cycle 1, a total body dose of 16U/kg (maximum 400U) of IncobotulinumtoxinA will be injected into the spastic muscles of the affected limbs.
During cycle 2, a total body dose of 19U/kg (maximum 475U) of IncobotulinumtoxinA will be injected into the spastic muscles of the affected limbs. If a dose of 19U/kg is not justified (i.e., for clinical or safety reasons) but BoNT-A treatment is still needed (according to the clinical condition of patients) the same dose injected in cycle 1 (16U/Kg; maximum 400U) may be administered in the cycle 2.
During cycle 3, a total body dose of 22U/kg (maximum 550U) of IncobotulinumtoxinA will be injected into the spastic muscles of the affected limbs. If a dose of 22U/kg is not justified (i.e., for clinical or safety reasons) but BoNT-A treatment is still needed (according to the clinical condition of patients) the same dose injected in cycle 2 (19U/Kg; maximum 475U) may be administered in the cycle 3.
Who can participate
Age range
2 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 (i.e. physiatrist)
* Focal spasticity scored at least 2 points on the Ashworth scale (AS) in the joints associated 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 the last injection at least 5 months
* Informed consent signed by parents or legal guardian.
Exclusion Criteria:
* 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 penalization
* Other neurological or orthopaedic conditions involving the affected limbs.
Specific vulnerable populations:
* institutionalized patients will not be included
* girls of childbearing potential (defined as females with a history of menarche) will not be included.
Withdrawal criteria for single patients:
* Serious adverse event (SAE)
* Development of dysphagia and/or aspiration pneumonia.
* Withdrawal of consent
* Inability…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ashworth Scale
Timeframe: During the screening assessment
2
Ashworth Scale
Timeframe: Immediately before each IncobotulinumtoxinA treatment session
3
Ashworth Scale
Timeframe: During the follow-up clinical assessment at 4 weeks from each injection
4
Ashworth Scale
Timeframe: During the follow-up clinical assessment at 12 weeks from each injection