Current partner codePEPTIDESDE
NCT01992562·Phase 4·INTERVENTIONAL

Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy

Status

Withdrawn

Phase

Phase 4

Enrollment

0

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Ziconotide

DRUG

placebo

Timeline

From registration to results.

  1. First posted

    Nov 25, 2013

  2. Study start

    Jan 2014

  3. Primary completion

    Dec 2015

  4. Study completion

    Dec 2015

  5. Results posted

    Not reported

  6. Registry updated

    Sep 18, 2018

Outcomes

What the study measures.

Primary outcomes

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 outcomes

Numerical Rating Scale of Pain (NRS)

Time frame · within 8 hours of Injection

Used to measure pain intensity on a 0-10 scale.

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.

Pittsburgh Sleep Quality Index (PSQI)

Time frame · within a week of injection

Used to measure the quality and patterns of sleep in adults.

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

The Ohio State University Department of Neurology

Columbus, Ohio, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Ziconotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.