Spastic Cerebral PalsyPhase 2INCIPITNCT05340439
INcobotulinumtoxina in ChIldren Upper and Lower Limb sPasticITy (INCIPIT)
A Phase 2 study testing IncobotulinumtoxinA 100 UNT [Xeomin] in people with Spastic Cerebral Palsy, run by Universita di Verona.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- IncobotulinumtoxinA 100 UNT [Xeomin]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
- Co-administration of aminoglycoside antibiotics, spectinomycin, 4-aminoquinoline, anticholinergic drugs, AbobotulinumtoxinA, OnabotulinumtoxinA or other agents interfering with neuromuscular transmission (e.g., tubocurarine-type muscle relaxants).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
The population involved will be children (either BoNT-A treatment-naïve or pre-treated) with multifocal spasticity of the upper and lower limb due to cerebral palsy, scheduled to receive at least one dose of 16 U/kg (maximum 400U) of IncobotulinumtoxinA. No stratification by gender or age is planned.
Our main aim will be 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.
Our secondary aim will be to investigate the safety 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.
Treatment procedures BoNT-A has been established as effective and safe (Level A recommendation) for the treatment of childhood spasticity in CP [18]. It acts in the cytosol of nerve endings and inhibits the release of acetylcholine at neuromuscular junctions by cleaving the synaptosomal-associated protein of 25kDa, which is required for vesicle docking and, consequently, neurotransmitter release. BoNT-A injections guided by ultrasonography are allowed into the spastic muscle affected limbs of both body sides.
Considering a dose of 16 U/kg (maximum 400U) licensed for OnabotulinumoxinA and a conversion ratio of 1:1 between OnabotulinumtoxinA and IncobotulinumtoxinA was defined the following dose for cycle 1 according to Law 648/96. Dose titration was defined according to the previous evidence in adults coming from the Tower study [10].
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 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.
In 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 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).
As to cycles 2 and 3, the following clinical and safety issues will be considered to not justify the dose increase to 19U/kg or 22U/kg: full achievement of the goals set on the GAS as a consequence of a clinically significant reduction of treated muscle tone (quantifiable in at least 1 point on the AS); occurrence of the adverse events reported in paragraph 7 (risks and benefits) and not included in the "withdrawal criteria".
Concomitant therapies
Co-administration of the following drugs will not be allowed during the study period:
- Aminoglycoside antibiotics
- Spectinomycin
- Agents interfering with neuromuscular transmission (e.g. tubocurarine-type muscle relaxants)
- 4-Aminoquinoline
- Anticholinergic drugs
- AbobotulinumtoxinA (Dysport) and OnabotulinumtoxinA (Botox) Thus, in case these drugs will be needed/administered, the patient will have to withdraw from the study.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- IncobotulinumtoxinA 100 UNT [Xeomin]
- Keywords
- Cerebral Palsy, Botulinum toxin type A, Spasticity, Titration study
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: IncobotulinumtoxinA 100 UNT [Xeomin] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: During the follow-up clinical assessment at 12 weeks from each injection
Secondary outcomes (6)
REsistance to PAssive movement Scale (REPAS)
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the AS. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items).
Measured: 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)
Is a 5 level classification system that describes the gross motor function of people with cerebral palsy (I=can walk indoors and outdoors and climb stairs without using hands for support; II=can climb stairs with a railing, has difficulty with uneven surfaces, inclines or in crowds; III=walks with assistive mobility devices indoors and outdoors on level surfaces, may be able to climb stairs using a railing, may propel a manual wheelchair and need assistance for long distances or uneven surfaces; IV=walking ability severely limited even with assistive devices, uses wheelchairs most of the time and may propel own power wheelchair, standing transfers, with or without assistance; V=has physical impairments that restrict voluntary control of movement, ability to maintain head and neck position against gravity restricted, impaired in all areas of motor function, cannot sit or stand independently, even with adaptive equipment).
Measured: 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)
The VAS, which is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: Immediately before each IncobotulinumtoxinA treatment session; at the follow-up clinical assessment at 4 and 12 weeks from each injection
Goal Attainment scale (GAS)
The GAS measures the extent to which a subject's individual goals are achieved in course of intervention. The subject and treating team have to identify 2 personal goals for each treated limb at each injection cycle. Investigator rates the GAS score for each injection cycle. The degree of goal attainment is rated on a 5-point scale (-2, -1, 0, +1, +2; study baseline set to -1) and in order to account for interindividual differences in the number of goals (positive values indicate higher goal attainment).
Measured: Immediately before each IncobotulinumtoxinA treatment session; at the follow-up clinical assessment at 4 and 12 weeks from each injection
Global Assessment of Efficacy
The Global Assessment of Efficacy, which will be assessed by the investigator, the patient (if possible), and the caregiver using a 4-point Likert scale with the ratings 1 = very good, 2 =good, 3 = moderate, and 4 = poor.
Measured: At the follow-up clinical assessment at 4 and 12 weeks from each injection
Global Assessment of Tolerability
The Global Assessment of Tolerability, which will be assessed by the investigator at each injection cycle control [V3, V6, V9] and end of cycle visits [V4, V7, V10] using a 4-point Likert scale with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.
Measured: At the follow-up clinical assessment at 4 and 12 weeks from each injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study startJun 2022 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Prospective, open-label, non-randomized, single-arm, dose titration, phase II study.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Smania, MD, Clinical Professor, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340439
- Sponsor's protocol ID
- INCIPIT
- Acronym
- INCIPIT
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05340439
- Acronym / sponsor ID
- INCIPIT / INCIPIT
- Conditions
- Spastic Cerebral Palsy
- Keywords
- Cerebral Palsy, Botulinum toxin type A, Spasticity, Titration study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The population involved will be children (either BoNT-A treatment-naïve or pre-treated) with multifocal spasticity of the upper and lower limb due to cerebral palsy, scheduled to receive at least one dose of 16 U/kg (maximum 400U) of IncobotulinumtoxinA. No stratification by gender or age is planned.
Our main aim will be 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.
Our secondary aim will be to investigate the safety 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.
Treatment procedures BoNT-A has been established as effective and safe (Level A recommendation) for the treatment of childhood spasticity in CP [18]. It acts in the cytosol of nerve endings and inhibits the release of acetylcholine at neuromuscular junctions by cleaving the synaptosomal-associated protein of 25kDa, which is required for vesicle docking and, consequently, neurotransmitter release. BoNT-A injections guided by ultrasonography are allowed into the spastic muscle affected limbs of both body sides.
Considering a dose of 16 U/kg (maximum 400U) licensed for OnabotulinumoxinA and a conversion ratio of 1:1 between OnabotulinumtoxinA and IncobotulinumtoxinA was defined the following dose for cycle 1 according to Law 648/96. Dose titration was defined according to the previous evidence in adults coming from the Tower study [10].
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 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.
In 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 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).
As to cycles 2 and 3, the following clinical and safety issues will be considered to not justify the dose increase to 19U/kg or 22U/kg: full achievement of the goals set on the GAS as a consequence of a clinically significant reduction of treated muscle tone (quantifiable in at least 1 point on the AS); occurrence of the adverse events reported in paragraph 7 (risks and benefits) and not included in the "withdrawal criteria".
Concomitant therapies
Co-administration of the following drugs will not be allowed during the study period:
- Aminoglycoside antibiotics
- Spectinomycin
- Agents interfering with neuromuscular transmission (e.g. tubocurarine-type muscle relaxants)
- 4-Aminoquinoline
- Anticholinergic drugs
- AbobotulinumtoxinA (Dysport) and OnabotulinumtoxinA (Botox) Thus, in case these drugs will be needed/administered, the patient will have to withdraw from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open-label, non-randomized, single-arm, dose titration, phase II study.
| Arm | Type | Receives |
|---|---|---|
| Incobotulinumtoxin A treatment | Experimental | Drug: IncobotulinumtoxinA 100 UNT [Xeomin]The study will consist of three injection cycles. In each, an injection visit is followed by an observation period of 12 to 20 weeks. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IncobotulinumtoxinA 100 UNT [Xeomin]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). | Drug | Incobotulinumtoxin A treatment |
Primary outcome
Ashworth Scale
Time frame: During the screening assessment
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).
Ashworth Scale
Time frame: Immediately before each IncobotulinumtoxinA treatment session
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).
Ashworth Scale
Time frame: During the follow-up clinical assessment at 4 weeks from each injection
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).
Ashworth Scale
Time frame: During the follow-up clinical assessment at 12 weeks from each injection
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).
6 secondary outcomes
REsistance to PAssive movement Scale (REPAS)
Time frame: 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)
Time frame: 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)
Time frame: Immediately before each IncobotulinumtoxinA treatment session; at the follow-up clinical assessment at 4 and 12 weeks from each injection
Goal Attainment scale (GAS)
Time frame: Immediately before each IncobotulinumtoxinA treatment session; at the follow-up clinical assessment at 4 and 12 weeks from each injection
Global Assessment of Efficacy
Time frame: At the follow-up clinical assessment at 4 and 12 weeks from each injection
Global Assessment of Tolerability
Time frame: At the follow-up clinical assessment at 4 and 12 weeks from each injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IncobotulinumtoxinA 100 UNT [Xeomin] in people with Spastic Cerebral Palsy, run by Universita di Verona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Smania, Prof. (0458124573 ext. 0039, nicola.smania@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ashworth Scale (time frame: During the screening assessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.