Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy

• Status: Withdrawn
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aaron Boster
• Treatments: omega-Conotoxins; Ziconotide

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