BridgeMD
Intranasal Cenegermin in Pediatric Participants with Spastic Cerebral Palsy.
EU CTIS ID: 2025-522786-29-00
What this study is testing
To evaluate the safety and tolerability of intranasal cenegermin in pediatric participants with spastic CP.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male and female participants ≥2 and ≤6 years of age.
- 2. Confirmed diagnosis of predominantly spastic cerebral palsy with a spasticity score of ≥2 on the MAS in at least one joint
- 3. Gross Motor Function Classification System – Expanded & Revised (GMFCS-E&R) levels I, II, III, IV, or V.
- 4. Body weight ≥8 kg (participants >30 kg may be included at the investigator’s judgement and upon medical monitor review with dosing modifications as needed)
- 5. Currently receiving physical and/or occupational therapy for at least 3 months prior to informed consent and for the duration of the study.
You likely can't join if
- 1. Any progressive or unstable medical conditions.
- 2. Recent changes in oral or injectable anti-spasticity treatments during Part 1 only.
- 3. Use of intrathecal baclofen pump.
- 4. Severe joint contractures or epilepsy.
- 5. Behavioral barriers to participation.
- 6. Systemic immunosuppressive therapy (excluding corticosteroids).
See the full eligibility criteria
- 1. Male and female participants ≥2 and ≤6 years of age.
- 2. Confirmed diagnosis of predominantly spastic cerebral palsy with a spasticity score of ≥2 on the MAS in at least one joint
- 3. Gross Motor Function Classification System – Expanded & Revised (GMFCS-E&R) levels I, II, III, IV, or V.
- 4. Body weight ≥8 kg (participants >30 kg may be included at the investigator’s judgement and upon medical monitor review with dosing modifications as needed)
- 5. Currently receiving physical and/or occupational therapy for at least 3 months prior to informed consent and for the duration of the study.
- 1. Any progressive or unstable medical conditions.
- 2. Recent changes in oral or injectable anti-spasticity treatments during Part 1 only.
- 3. Use of intrathecal baclofen pump.
- 4. Severe joint contractures or epilepsy.
- 5. Behavioral barriers to participation.
- 6. Systemic immunosuppressive therapy (excluding corticosteroids).
- 7. Nasal abnormalities that may interfere with intranasal administration.
The study team makes the final eligibility decision.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.