SpasticityNCT06150729
Study of Intramuscular Injections of OnabotulinumtoxinA to Assess Change in Disease Activity in Pediatric Participants With Spasticity Associated With Cerebral Palsy
An observational study of Spasticity, run by AbbVie at 8 sites in Mexico.
Trial summary
Spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. Upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. This study will assess how effective OnabotulinumtoxinA is in treating pediatric participants with Spasticity. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Spasticity
- How many people
- 107 participants
- Where
- 8 sitesMexico
- Study dates
- 8 Sep 2023to 30 May 2025
- Phase
- Observational
- 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
Study population: Pediatric Participants (2-17 years) with spasticity associated with cerebral palsy.
Who may be able to join
- Unilateral/bilateral, upper/lower limb spasticity associated with cerebral palsy.
- Naïve to OnabotulinumtoxinA treatment and who, according to medical and to the standard clinical practice criteria, will receive OnabotulinumtoxinA.
- Treated only with stable doses of short-acting muscle relaxants can be included in the study, at the investigator's discretion, for at least 30 days prior to treatment starting, under the concept that at the time the steady state of the drug (stable plasma concentrations) will theoretically have been reached.
- Under adjuvant treatment with orthoses and other orthopedic devices can be included in the study.
- Participants with physio/physical therapy can be included.
Who cannot join
- Previously treated with botulinum toxin for spasticity related to cerebral palsy.
- Diagnosed with Eaton-Lambert syndrome, myasthenia gravis, or other neurological diseases with compromised neuromuscular transmission.
- History of hypersensitivity to the study drug or to any of the excipients in the formulation.
- Evidence of inflammation or infection in the anatomical region selected by the investigator for the study drug administration.
- Participants under treatment with drugs that interfere with neuromuscular transmission which, at the investigator's discretion, contraindicate OnabotulinumtoxinA concomitant administration.
- Have had orthopedic surgery in the segment to be infiltrated in the 12 months prior to drug application.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Mexico8 sites
Hospital General Regional 180 IMSS /ID# 261458
Guadalajara, Jalisco, 45653
Cri Dif Jalisco /Id# 261459
Guadalajara, 44270
Hospital General ISSSTE Tacuba /ID# 261460
Mexico City, Mexico City, 11410
Hospital General ISSSTE Tacuba /ID# 261932
Mexico City, Mexico City, 11410
Cree Dif Nuevo Leon /Id# 261454
Monterrey, Nuevo LEON, Nuevo León, 64790
Clinica de Rehabilitacion Integral Yupi /Id# 261461
Puerto Vallarta, Jalisco, 48312
Crit Estado de México /Id# 261934
Tlalnepantla, 54010
Hospital Militar De Zona De Villahermosa /ID# 261451
Villahermosa, Tabasco, 86100
About this study
Official title: Botulinum A Toxin (OnabotulinumtoxinA) Use in Mexican Pediatric Population With Spasticity Associated With Cerebral Palsy: Phase IV, Observational, Non-Interventional, Prospective, Multicenter Study
Spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. Upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. This study will assess how effective OnabotulinumtoxinA is in treating pediatric participants with Spasticity. Change in disease activity will be evaluated.
OnabotulinumtoxinA is approved drug for treatment of Spasticity. Approximately 106 pediatric participants aged 2-17 years with spasticity associated with cerebral palsy will be enrolled in approximately 10 sites across Mexico.
Read more
Participants will receive OnabotulinumtoxinA as prescribed by their physician in accordance to local label and followed for 12 months.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits to a hospital or clinic in their routine practice.
- Conditions
- Spasticity
- Keywords
- Spasticity, Cerebral Palsy, OnabotulinumtoxinA
- Medical subject headings
- Muscle Spasticity, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OnabotulinumtoxinA | Participants will receive OnabotulinumtoxinA as prescribed by their physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Total Dose
OnabotulinumtoxinA total dose applied at visit will be assessed.
Measured: Up to 12 months
Total Dose Per Kilogram
OnabotulinumtoxinA total dose applied at each visit, divided by patient's body weight will be assessed.
Measured: Up to 12 months
Dose Per Muscle
OnabotulinumtoxinA dose applied to each muscle, regardless of punctures' number on that muscle will be assessed.
Measured: Up to 12 months
Application Sites Number Per Muscle
Number of puncture sites per muscle will be assessed.
Measured: Up to 12 months
Re-administration Interval
Re-administration interval is defined as number of days between drug application and previous application.
Measured: Up to 12 months
Needle Gauge
Needle gauge is defined as diameter of needle thickness with which study treatment is applied.
Measured: Up to 12 months
Needle Length
Needle length is defined as distance from the needle base to the needle bevel tip.
Measured: Up to 12 months
Preventive Pain Management Technique
Type of method used to control procedural pain will be assessed.
Measured: Up to 12 months
Method to Locate Application Site
Type of method used to identify muscle and treatment application site will be assessed.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start8 Sep 2023
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150729
- Sponsor's protocol ID
- P24-430
- Status last verified
- Aug 2026
- First submitted
- 21 Nov 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum A Toxin (OnabotulinumtoxinA) Use in Mexican Pediatric Population With Spasticity Associated With Cerebral Palsy: Phase IV, Observational, Non-Interventional, Prospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT06150729
- Acronym / sponsor ID
- P24-430
- Conditions
- Spasticity
- Keywords
- Spasticity, Cerebral Palsy, OnabotulinumtoxinA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 29 Nov 2023 (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.
Spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. Upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. This study will assess how effective OnabotulinumtoxinA is in treating pediatric participants with Spasticity. Change in disease activity will be evaluated.
OnabotulinumtoxinA is approved drug for treatment of Spasticity. Approximately 106 pediatric participants aged 2-17 years with spasticity associated with cerebral palsy will be enrolled in approximately 10 sites across Mexico.
Participants will receive OnabotulinumtoxinA as prescribed by their physician in accordance to local label and followed for 12 months.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits to a hospital or clinic in their routine practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OnabotulinumtoxinA | – | –Participants will receive OnabotulinumtoxinA as prescribed by their physician. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric Participants (2-17 years) with spasticity associated with cerebral palsy.
Key inclusion criteria (5 listed)
- Unilateral/bilateral, upper/lower limb spasticity associated with cerebral palsy.
- Naïve to OnabotulinumtoxinA treatment and who, according to medical and to the standard clinical practice criteria, will receive OnabotulinumtoxinA.
- Treated only with stable doses of short-acting muscle relaxants can be included in the study, at the investigator's discretion, for at least 30 days prior to treatment starting, under the concept that at the time the steady state of the drug (stable plasma concentrations) will theoretically have been reached.
- Under adjuvant treatment with orthoses and other orthopedic devices can be included in the study.
- Participants with physio/physical therapy can be included.
Key exclusion criteria (6 listed)
- Previously treated with botulinum toxin for spasticity related to cerebral palsy.
- Diagnosed with Eaton-Lambert syndrome, myasthenia gravis, or other neurological diseases with compromised neuromuscular transmission.
- History of hypersensitivity to the study drug or to any of the excipients in the formulation.
- Evidence of inflammation or infection in the anatomical region selected by the investigator for the study drug administration.
- Participants under treatment with drugs that interfere with neuromuscular transmission which, at the investigator's discretion, contraindicate OnabotulinumtoxinA concomitant administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Absolute Total Dose
Time frame: Up to 12 months
OnabotulinumtoxinA total dose applied at visit will be assessed.
Total Dose Per Kilogram
Time frame: Up to 12 months
OnabotulinumtoxinA total dose applied at each visit, divided by patient's body weight will be assessed.
Dose Per Muscle
Time frame: Up to 12 months
OnabotulinumtoxinA dose applied to each muscle, regardless of punctures' number on that muscle will be assessed.
Application Sites Number Per Muscle
Time frame: Up to 12 months
Number of puncture sites per muscle will be assessed.
Re-administration Interval
Time frame: Up to 12 months
Re-administration interval is defined as number of days between drug application and previous application.
Needle Gauge
Time frame: Up to 12 months
Needle gauge is defined as diameter of needle thickness with which study treatment is applied.
Needle Length
Time frame: Up to 12 months
Needle length is defined as distance from the needle base to the needle bevel tip.
Preventive Pain Management Technique
Time frame: Up to 12 months
Type of method used to control procedural pain will be assessed.
Method to Locate Application Site
Time frame: Up to 12 months
Type of method used to identify muscle and treatment application site will be assessed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Clinical Study Report SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Spasticity
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
RecruitingObservational study
Evaluation of Patients With HAM/TSP
HTLV-I Infection, Tropical Spastic Paraparesis
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.
ABBVIE INC. study director
AbbVie
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity, run by AbbVie at 8 sites in Mexico.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Total Dose (time frame: Up to 12 months). The study lists 9 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 6 Aug 2026.