Clinical trial NCT01992562: Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Painful Myelopathy
Painful Neuropathy
Lead sponsor: OhioHealth
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analog Scale of Pain Intensity (VASPI)
timeFrame: within 8 hours post injection
Secondary outcomes:
measure: Numerical Rating Scale of Pain (NRS)
timeFrame: within 8 hours of Injection
measure: Brief Pain Inventory (BPI) Scale
timeFrame: within a week of Injection
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: within a week of injection
measure: Patient Global Impression of Change (PGIC)
timeFrame: within 8 hours of injection
Other outcomes:
measure: Timed 25 Foot Walk Test (T25-FW)
timeFrame: within 8 hours of injection
Locations:
city: Columbus
country: United States
facility: The Ohio State University Department of Neurology
state: Ohio
Study officials:
affiliation: OhioHealth
name: Aaron L Boster, MD
role: PRINCIPAL_INVESTIGATOR
References: