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New treatment option for Cerebral Palsy
Official title Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy
ClinicalTrials.gov ID: NCT07434492
What this study is testing
What is 5-Azacitidine?
5-Azacitidine is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for cerebral palsy.
Also referred to as VIDAZA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an intervention study to investigate the impact of a smart ankle-foot orthosis (AFO) on mobility outcomes in children with Cerebral Palsy. Participants will complete a three phase protocol including 6-weeks of at home training with the smart AFO.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 17
You may be able to join if
- Diagnosis of cerebral palsy classified as Gross Motor Function Classification System (GMFCS) levels I to III
- Between 8 and 17 years and 8 months of age at the time of enrollment/consent. Participants that will turn 18 during the course of the study will not...
- Stable medical condition as determined by the investigator.
- Adequate caregiver support to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the PI.
- Height/weight/BMI between the 5th - 95th percentile of children with cerebral palsy
You likely can't join if
- Knee extension or ankle dorsiflexion contractures greater than 15 degrees
- Immunodeficiency or hematologic condition
- Allergy to AZA or mannitol
- Plans to receive a vaccine within 30 days of the planned AZA or placebo injection to take place at week 5
- Pregnancy
- Orthopedic surgery on the lower limbs completed in the prior 12 months
See the full eligibility criteria
- Diagnosis of cerebral palsy classified as Gross Motor Function Classification System (GMFCS) levels I to III
- Between 8 and 17 years and 8 months of age at the time of enrollment/consent. Participants that will turn 18 during the course of the study will not be included as pausing the at-home protocol until re-consenting is...
- Stable medical condition as determined by the investigator.
- Adequate caregiver support to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the PI.
- Height/weight/BMI between the 5th - 95th percentile of children with cerebral palsy
- Able to walk for at least 6 minutes (assisted or unassisted)
- Able to understand and follow simple directions
- Able to safely fit into a device configuration and tolerate assistance without knee hyperextension while walking
- At least 20 degrees of passive ankle plantar flexion range of motion
- Physician approval for participation
- Knee extension or ankle dorsiflexion contractures greater than 15 degrees
- Immunodeficiency or hematologic condition
- Allergy to AZA or mannitol
- Plans to receive a vaccine within 30 days of the planned AZA or placebo injection to take place at week 5
- Pregnancy
- Orthopedic surgery on the lower limbs completed in the prior 12 months
- New implanted device (e.g., baclofen pump) and/or active intrathecal medication titration that may affect muscle spasticity
- Botulinum toxin treatment within 3 months preceding enrollment unless given approval by the study physician
- Severe osteoporosis unless given approval by the study physician
- Current enrollment in a conflicting research study
- Any other health condition or diagnosis not listed above that may put the participant at risk as determined by the PI or study physician
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
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, 8 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.