INcobotulinumtoxina in ChIldren Upper and Lower Limb sPasticITy (INCIPIT)

NCT05340439 | Unknown Phase 2 DMC

• 1 other identifier: INCIPIT
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Spastic Cerebral Palsy

Keywords

Cerebral Palsy; Botulinum toxin type A; Spasticity; Titration study

Outcome Measures

Primary Outcomes (4)

• Ashworth Scale

  The Ashworth scale is a well-known and commonly used scale in clinical trials with spasticity. It will be used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

  During the screening assessment

• Ashworth Scale

  The Ashworth scale is a well-known and commonly used scale in clinical trials with spasticity. It will be used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

  Immediately before each IncobotulinumtoxinA treatment session

• Ashworth Scale

  The Ashworth scale is a well-known and commonly used scale in clinical trials with spasticity. It will be used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

  During the follow-up clinical assessment at 4 weeks from each injection

• Ashworth Scale

  The Ashworth scale is a well-known and commonly used scale in clinical trials with spasticity. It will be used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

  During the follow-up clinical assessment at 12 weeks from each injection

Secondary Outcomes (6)

• REsistance to PAssive movement Scale (REPAS)

  Immediately before each IncobotulinumtoxinA treatment session; at the follow-up clinical assessment at 4 and 12 weeks from each injection

• Gross Motor Function Classification System (GMFCS)

  During the screening assessment; immediately before each IncobotulinumtoxinA treatment session; at the follow-up clinical assessment at 4 and 12 weeks from each injection

• Visual Analog Scale (VAS)

  Immediately before each IncobotulinumtoxinA treatment session; at the follow-up clinical assessment at 4 and 12 weeks from each injection

• Goal Attainment scale (GAS)

  Immediately before each IncobotulinumtoxinA treatment session; at the follow-up clinical assessment at 4 and 12 weeks from each injection

• Global Assessment of Efficacy

  At the follow-up clinical assessment at 4 and 12 weeks from each injection

Study Arms (1)

Incobotulinumtoxin A treatment

EXPERIMENTAL

The study will consist of three injection cycles. In each, an injection visit is followed by an observation period of 12 to 20 weeks.

Drug: IncobotulinumtoxinA 100 UNT [Xeomin]

Interventions

IncobotulinumtoxinA 100 UNT [Xeomin] DRUG

In cycle 1, a total body dose of 16U/kg (maximum 400U) of IncobotulinumtoxinA will be injected into the spastic muscles of the affected limbs. In cycle 2, a total body dose of 19U/kg (maximum 475U) of IncobotulinumtoxinA will be injected. 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. In cycle 3, a total body dose of 22U/kg (maximum 550U) of IncobotulinumtoxinA will be injected. 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 600U) may be administered in the cycle 3 (if the patient has been treated with 16U/kg in cycle 2, a dose of 19U/kg may be injected in cycle 3).

Incobotulinumtoxin A treatment

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify 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 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 to follow the study according to its design and time points

Sponsors & Collaborators

• Universita di Verona: lead

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Interventions

incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nicola Smania, Prof.

CONTACT

0458124573; nicola.smania@univr.it

Alessandro Picelli, Prof.

CONTACT

0458124573; alessandro.picelli@univr.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Prospective, open-label, non-randomized, single-arm, dose titration, phase II study.

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 22, 2022
• Study Start: June 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: May 1, 2025
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share