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baclofen, intrathecal · 1 trial · 2 indications
| Name | Type | Description |
|---|---|---|
| baclofen, intrathecal | DRUG | - |
| infusion pump for intrathecal baclofen, Synchromed, Medtronic | DEVICE | - |
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...
Baclofen intrathecal is used for treating spasticity in children with cerebral palsy. It is administered directly into the spinal fluid via an intrathecal pump. In clinical trials, it has been studied in patients aged 4 years and older with cerebral palsy and spasticity.
Baclofen intrathecal is developed by Medtronic plc, a medical device company traded on the New York Stock Exchange under the ticker MDT. Medtronic is responsible for the intrathecal delivery system and the drug product used in this indication.
Baclofen intrathecal is in Phase 3 clinical development for cerebral palsy. It has completed one Phase 3 trial, and it remains an investigational therapy for this indication, meaning it is not yet approved for cerebral palsy based on the available trial data.
Baclofen intrathecal has been studied in one completed Phase 3 trial, NCT00367068, titled "Dutch National ITB Study in Children With Cerebral Palsy." This trial enrolled 18 participants in the Netherlands and evaluated the treatment in children with cerebral palsy and spasticity.
Baclofen intrathecal is a formulation of baclofen delivered directly into the intrathecal space, bypassing the blood-brain barrier. It is distinct from oral baclofen, which is taken by mouth. The intrathecal route allows for higher drug concentrations in the spinal fluid with lower systemic doses.