Intrathecal baclofen pump versus selective dorsal rhizotomy for non-ambulatory children with cerebral palsy

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518822-33-01

Enrollment

Registered

2026-01-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Brief summary

Change in CP-CHILD caregiver version (in absolute value) in the first year postoperatively vs. immediately preoperatively (non-inferiority margin = clinically meaningful difference = 5/100).

Detailed description

Key secondary endpoints: Adverse events; cost-effectiveness and cost-utility. Additional secondary endpoints: Spasticity; range of motion; trunk control; communication; orobulbar function; sleep; urinary symptoms; spinal/hip deformities; medication use; quality of life; treatment goals; parental distress; patient satisfaction; healthcare costs; complications.

Interventions

DRUGLioresal® Intrathecal Infusion 10mg/5ml

DRUGLioresal® Intrathecal Infusion 10mg/20ml

DRUGBaclofen Aguettant 2 mg/mL solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Change in CP-CHILD caregiver version (in absolute value) in the first year postoperatively vs. immediately preoperatively (non-inferiority margin = clinically meaningful difference = 5/100).	—

Secondary

Measure	Time frame
Key secondary endpoints: Adverse events; cost-effectiveness and cost-utility. Additional secondary endpoints: Spasticity; range of motion; trunk control; communication; orobulbar function; sleep; urinary symptoms; spinal/hip deformities; medication use; quality of life; treatment goals; parental distress; patient satisfaction; healthcare costs; complications.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026