A Study of Serum Baclofen Levels in Patients with Intrathecal Baclofen Therapy

Overview

About this study

The purpose of this study is to determine serum levels of baclofen in patients with spasticity managed with long-term intrathecal baclofen therapy. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age > 18 years old.
  • Clinical diagnosis of spasticity as a result of upper motor neuron dysfunction.
  • Spasticity of upper or lower extremities, resulting in either cervical, thoracic or lumbar catheter location.
  • Previous targeted drug delivery device with baclofen monotherapy > 90 days.
  • The use of oral opioid and non-baclofen antispasmodic medications are permissible.
  • Documented MAS assessment.

Exclusion Criteria:

  • Use of oral baclofen within the previous 3 days.
  • Targeted drug delivery device utilizing medications other than baclofen monotherapy.
  • Targeted drug delivery device that was implanted < 90 days prior to recruitment.
  • Unstable patient requiring hospitalization for management of life threatening medical issue.
  • End-stage liver (Child-Pugh classification A or greater) or kidney disease (creatinine clearance < 30 ml/min).
  • Presence of a psychiatric disorder that would limit obtaining informed consent or functioning in an ambulatory environment (e.g., dementia, schizophrenia, severe depression, substance abuse disorder).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Thomas Pittelkow, D.O., M.P.H.

Contact us for the latest status

Contact information:

Thomas Pittelkow D.O., M.P.H.

Pittelkow.Thomas@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20472915

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