Taking peoplePhase 2
Intranasal Cenegermin in Pediatric Participants with Spastic Cerebral Palsy.
Key facts
- Who runs it
- Dompe' Farmaceutici S.p.A.
- Where
- Italy12 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 60 people, planned
- Started
- 7 Jan 2026
- Expected to end
- 30 Jun 2029
- Type of study
- Interventional
- Record updated
- 23 July 2026
Who can take part
- Age
- Up to 17 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Male and female participants ≥2 and ≤6 years of age
- Confirmed diagnosis of predominantly spastic cerebral palsy with a spasticity score of ≥2 on the MAS in at least one joint
- Gross Motor Function Classification System – Expanded & Revised (GMFCS-E&R) levels I, II, III, IV, or V
- 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)
- Currently receiving physical and/or occupational therapy for at least 3 months prior to informed consent and for the duration of the study
Who cannot take part
- Systemic immunosuppressive therapy (excluding corticosteroids)
- Any progressive or unstable medical conditions
- Severe joint contractures or epilepsy
- Recent changes in oral or injectable anti-spasticity treatments during Part 1 only
- Use of intrathecal baclofen pump
- Behavioral barriers to participation
- Nasal abnormalities that may interfere with intranasal administration
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
To evaluate the safety and tolerability of intranasal cenegermin in pediatric participants with spastic CP.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Randomized, Double-Blinded, Vehicle-Controlled, Crossover Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Pediatric Participants with Spastic Cerebral Palsy (CP).
- Record updated
- 23 July 2026