Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy

A Phase 4, Randomized, Double-blind, Placebo-controlled, Cross-over Clinical Trial of a Single Shot of Intrathecal Ziconotide for the Treatment of Chronic, Medically Refractory Pain From Painful Peripheral Neuropathy or Myelopathy

Sponsors

Lead Sponsor: Aaron Boster

Source OhioHealth
Brief Summary

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.

Detailed Description

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.

Overall Status Withdrawn
Start Date 2014-01-01
Completion Date 2015-12-01
Primary Completion Date 2015-12-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Visual Analog Scale of Pain Intensity (VASPI) within 8 hours post injection
Secondary Outcome
Measure Time Frame
Numerical Rating Scale of Pain (NRS) within 8 hours of Injection
Brief Pain Inventory (BPI) Scale within a week of Injection
Pittsburgh Sleep Quality Index (PSQI) within a week of injection
Patient Global Impression of Change (PGIC) within 8 hours of injection
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ziconotide

Arm Group Label: Treatment

Other Name: Prialt

Intervention Type: Drug

Intervention Name: placebo

Arm Group Label: Placebo

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Aaron L Boster, MD Principal Investigator OhioHealth
Location
Facility: The Ohio State University Department of Neurology
Location Countries

United States

Verification Date

2018-09-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: OhioHealth

Investigator Full Name: Aaron Boster

Investigator Title: Clinical Neuroimmunologist

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Treatment

Type: Experimental

Description: 5 mcg ziconotide in 1ml of normal saline bolus intrathecal injection

Label: Placebo

Type: Placebo Comparator

Description: 1ml of normal saline bolus intrathecal injection

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

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