Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy
Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy
This is a phase 4 study being conducted at the Ohio State University Department of Neurology
 Multiple Sclerosis Research Program. The purpose of the study is to administer a single shot
 of intrathecal (injection into the space surrounding the spinal cord via a lumbar puncture or
 spinal tap) ziconotide as a test dose to patients who have chronic painful myelopathy (pain
 from spinal cord damage) or painful peripheral neuropathy (pain from nerve damage) that has
 not responded to other pain medicines.
Study Hypothesis: We intend to determine if a single shot trial (SST) of intrathecal (IT)
 ziconotide will temporarily reduce pain in these patients. In the proposed study, patients
 will receive two injections, one of which is the ziconotide and one which is a placebo. They
 will be blinded and not know which order they receive the treatment versus placebo. The
 results of this clinical trial will provide a focused examination of ziconotide efficacy and
 safety in patients with painful neuropathies or myelopathies that have not been effectively
 treated with other pain medications. Moreover, the use of a single shot trial (SST) IT
 injection in the outpatient setting will provide evidence for application of this technique
 in outpatient neurological clinical practice, thereby improving access to this specific
 patient population. Ziconotide is currently FDA approved for this indication and route of
 administration. Therefore, a study design that improves the feasibility of ziconotide
 trialing specifically in the neurology clinic (that is, single shot administration) is being
 used in order to ensure its broader use by neurologists who routinely care for neuropathy and
 myelopathy patients. Information from this study will also inform future studies of
 predictors for long term efficacy after pump placement.
Inclusion Criteria:

 1. Men or women 18 years or older.

 2. Neuropathic pain due to peripheral neuropathy or myelopathy

 3. Duration of condition greater than 6 months

 4. Inadequate control with trials of three or more analgesic agents considered standard
 care for treatment of neuropathic pain; treatment failure can be either due to lack of
 efficacy or to intolerable side effects.

 5. Documented normal CK and GFR within 6 months preceding screening.

 6. Baseline BPI pain severity subscale score of >5/10

 Exclusion Criteria:

 1. Renal insufficiency

 2. History of Myopathy or persistently elevated CK levels

 3. History of prior suicide attempt or ideation

 4. History of Psychosis

 5. Pregnancy or breastfeeding

 6. Inability or unwillingness to use contraception

 7. Inability to provide consent

 8. Inability to tolerate lumbar punctures

 9. Receiving systemic anticoagulation therapy (eg. Coumadin)

 10. Inability/unwilling to self-catheterize if indicated

 11. Change (start, stop, adjust) in home medications 30 days prior to screening visit.

 12. Baseline CES-D score > 30

 13. Subject has previously failed ziconotide treatment

 14. Other factors that in the opinion of the PI would exclude the subject from
 participation in the study