Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy

NCT01992562 | Withdrawn Phase 4

• 1 other identifier: PRIALT01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Painful Myelopathy; Painful Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Numerical Rating Scale of Pain (NRS)

  within 8 hours of Injection

• Brief Pain Inventory (BPI) Scale

  within a week of Injection

• Pittsburgh Sleep Quality Index (PSQI)

  within a week of injection

• Patient Global Impression of Change (PGIC)

  within 8 hours of injection

Other Outcomes (1)

• Timed 25 Foot Walk Test (T25-FW)

  within 8 hours of injection

Study Arms (2)

Treatment

EXPERIMENTAL

5 mcg ziconotide in 1ml of normal saline bolus intrathecal injection

Drug: Ziconotide

Placebo

PLACEBO COMPARATOR

1ml of normal saline bolus intrathecal injection

Drug: placebo

Interventions

Ziconotide DRUG

Also known as: Prialt

Treatment

placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women 18 years or older.
• Neuropathic pain due to peripheral neuropathy or myelopathy
• Duration of condition greater than 6 months
• 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.
• Documented normal CK and GFR within 6 months preceding screening.
• Baseline BPI pain severity subscale score of \>5/10

You may not qualify if:

• Renal insufficiency
• History of Myopathy or persistently elevated CK levels
• History of prior suicide attempt or ideation
• History of Psychosis
• Pregnancy or breastfeeding
• Inability or unwillingness to use contraception
• Inability to provide consent
• Inability to tolerate lumbar punctures
• Receiving systemic anticoagulation therapy (eg. Coumadin)
• Inability/unwilling to self-catheterize if indicated
• Change (start, stop, adjust) in home medications 30 days prior to screening visit.
• Baseline CES-D score \> 30
• Subject has previously failed ziconotide treatment
• Other factors that in the opinion of the PI would exclude the subject from participation in the study

Sponsors & Collaborators

• Aaron Boster: lead

Study Sites (1)

The Ohio State University Department of Neurology

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Neuropathy, Painful

Interventions

ziconotide

Study Officials

• Aaron L Boster, MD

  OhioHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Neuroimmunologist

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 25, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

US (1)