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baclofen, intrathecal

Phase 3

Cerebral Palsy | Small molecule | Neurology |Medtronic plc.|Last Updated: Nov 19, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00367068Dutch National ITB Study in Children With Cerebral PalsyPHASE3 COMPLETED 18 — — Jan 1, 2002May 1, 2007Nov 19, 20071 Netherlands
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Study Endpoints
Primary Endpoints
For the double-blind, placebo-controlled dose-escalation test treatment phase:
original Ashworth Scale.
For the prospective, randomized, open-label implantation and follow-up phase:
PEDI, GMFM, original Ashworth Scale, Visual Analogue Scale (VAS) at 6 months.
Secondary Endpoints
For the double-blind, placebo-controlled dose-escalation test treatment phase:
Visual Analogue Scale (VAS).
For the prospective, randomized, open-label implantation and follow-up phase:
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
baclofen, intrathecalDRUG -
infusion pump for intrathecal baclofen, Synchromed, MedtronicDEVICE -
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Eligibility Criteria
Age Range4 Years — 16 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * age between 4 and 16 years * spastic diplegia or tetraplegia as part of CP * insufficient response to oral spasticity-reducing medication * in a mixed CP syndrome, spasticity has to be the most prominent sign * spasticity results in a decrease in the quality of life of the chi...

Countries:Netherlands
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