Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Painful Myelopathy, Painful Neuropathy

In brief

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.

Key facts

Study ID

NCT01992562

Run by

Aaron Boster

People needed

0

Starts

2014-01-01

Expected to finish

2015-12-01

Last updated by the study team

2018-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women 18 years or older.
• Neuropathic pain due to peripheral neuropathy or myelopathy
• Duration of condition greater than 6 months
• 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.
• Documented normal CK and GFR within 6 months preceding screening.
• Baseline BPI pain severity subscale score of >5/10

You may not qualify if…

• Renal insufficiency
• History of Myopathy or persistently elevated CK levels
• History of prior suicide attempt or ideation
• History of Psychosis
• Pregnancy or breastfeeding
• Inability or unwillingness to use contraception
• Inability to provide consent
• Inability to tolerate lumbar punctures
• Receiving systemic anticoagulation therapy (eg. Coumadin)
• Inability/unwilling to self-catheterize if indicated
• Change (start, stop, adjust) in home medications 30 days prior to screening visit.
• Baseline CES-D score > 30
• Subject has previously failed ziconotide treatment
• Other factors that in the opinion of the PI would exclude the subject from participation in the study

Where it is running

• The Ohio State University Department of Neurology — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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