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Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy

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ClinicalTrials.gov Identifier: NCT01992562
Recruitment Status : Withdrawn (Logistical issues with study process and recruitment)
First Posted : November 25, 2013
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Aaron Boster, 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.

Condition or disease Intervention/treatment Phase
Painful Myelopathy Painful Neuropathy Drug: Ziconotide Drug: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ziconotide

Arm Intervention/treatment
Experimental: Treatment
5 mcg ziconotide in 1ml of normal saline bolus intrathecal injection
Drug: Ziconotide
Other Name: Prialt

Placebo Comparator: Placebo
1ml of normal saline bolus intrathecal injection
Drug: placebo



Primary Outcome Measures :
  1. Visual Analog Scale of Pain Intensity (VASPI) [ Time Frame: within 8 hours post injection ]
    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.


Secondary Outcome Measures :
  1. Numerical Rating Scale of Pain (NRS) [ Time Frame: within 8 hours of Injection ]
    Used to measure pain intensity on a 0-10 scale.

  2. Brief Pain Inventory (BPI) Scale [ Time Frame: within a week of Injection ]
    Used to assess the severity of pain and the impact of pain on daily functions.

  3. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: within a week of injection ]
    Used to measure the quality and patterns of sleep in adults.

  4. Patient Global Impression of Change (PGIC) [ Time Frame: within 8 hours of injection ]
    Used to assess the patient's belief about the efficacy of their treatment.


Other Outcome Measures:
  1. Timed 25 Foot Walk Test (T25-FW) [ Time Frame: within 8 hours of injection ]
    A quantitative mobility and leg function performance test based on a timed 25-foot walk.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992562


Locations
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United States, Ohio
The Ohio State University Department of Neurology
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
Aaron Boster
Investigators
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Principal Investigator: Aaron L Boster, MD OhioHealth

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Responsible Party: Aaron Boster, Clinical Neuroimmunologist, OhioHealth
ClinicalTrials.gov Identifier: NCT01992562     History of Changes
Other Study ID Numbers: PRIALT01
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Spinal Cord Diseases
Bone Marrow Diseases
Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Central Nervous System Diseases
Hematologic Diseases
Ziconotide
omega-Conotoxins
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents