Screening Trial

  • When oral baclofen, or other treatments, do not provide the desired results, ITB Therapy℠ with Lioresal® Intrathecal offers another treatment option.
  • Lioresal® Intrathecal offers the unique opportunity to try out intrathecal baclofen to see how it affects severe spasticity in a 1-day screening trial.
  • 97% of patients with spasticity of spinal origin1 and 94% of patients with spasticity of cerebral origin have positive responses in the screening trial of Lioresal® Intrathecal.2
  • ITB Therapy (Intrathecal Baclofen Therapy) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, ITB Therapy via an implantable infusion system should be reserved for patients unresponsive to oral baclofen or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. This therapy is contraindicated in patients who are hypersensitive to baclofen. Implantation of the infusion system is contraindicated if the patient is of insufficient body size, requires a pump implant deeper than 2.5 cm, or, in the presence of spinal anomalies or active infection.
  • Good candidates for a treatment with Lioresal® Intrathecal are those who are clinically stable, understand the risks and benefits associated with ITB Therapy℠ with Lioresal® Intrathecal, are able to return to the clinic for dosage titration and periodic pump refills, have demonstrated a positive response in the screening trial.
  1. Penn R. Intrathecal baclofen for spasticity of spinal origin: seven years of experience. J Neurosurg. 1992;77:236-240.
  2. Gilmartin R, Bruce D, Storrs B, et al. Intrathecal baclofen for management of spastic cerebral palsy: Multicenter trial. J Child Neurol. 2000;15(2):71-77.

Important Safety Information for Lioresal® Intrathecal (baclofen injection)

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS).

Indications and Usage


Select Warnings and Precautions

Adverse Reactions

Common Adverse Reactions

Serious Adverse Reactions

Postmarketing Experience

Use in Specific Populations

For more information, including BOXED WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information.