Painful Neuropathy Clinical Trial
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
NCT number | NCT01992562 |
Other study ID # | PRIALT01 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | January 2014 |
Est. completion date | December 2015 |
Verified date | September 2018 |
Source | OhioHealth |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University Department of Neurology | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Aaron Boster |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Timed 25 Foot Walk Test (T25-FW) | A quantitative mobility and leg function performance test based on a timed 25-foot walk. | within 8 hours of injection | |
Primary | Visual Analog Scale of Pain Intensity (VASPI) | The primary outcome measure of this study is to determine the efficacy of single shot IT ziconotide in treatment of refractory neuropathic pain as a result of painful peripheral neuropathy or myelopathy and to determine the maximal decrease from baseline in VASPI (Visual Analog Scale of Pain Intensity). A responder analysis will also be performed for the VASPI. | within 8 hours post injection | |
Secondary | Numerical Rating Scale of Pain (NRS) | Used to measure pain intensity on a 0-10 scale. | within 8 hours of Injection | |
Secondary | Brief Pain Inventory (BPI) Scale | Used to assess the severity of pain and the impact of pain on daily functions. | within a week of Injection | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) | Used to measure the quality and patterns of sleep in adults. | within a week of injection | |
Secondary | Patient Global Impression of Change (PGIC) | Used to assess the patient's belief about the efficacy of their treatment. | within 8 hours of injection |
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