Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy
WithdrawnPhase 4NCT01992562
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- 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
- Conditions
- Painful Myelopathy
- Painful Neuropathy
- Interventions
- Sponsor
- Aaron Boster
- Organization
- OhioHealth
- Start date
- 2014-01
- Primary completion
- 2015-12
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01992562