DRUG
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Withdrawn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
placebo
Timeline
From registration to results.
First posted
Nov 25, 2013
Study start
Jan 2014
Primary completion
Dec 2015
Study completion
Dec 2015
Results posted
Not reported
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.
Related trials
More studies on Ziconotide.
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Not applicable
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Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy
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Not applicable
Not yet recruiting
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2026-03
OP2C : Prialt® Observatory in Clinical Practice
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Ziconotide for Non-cancer Pain by Intrathecal Administration
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Not applicable
Recruiting
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2025-02
Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer
National Cancer Institute, Naples · Pain · Neuropathic Pain
Phase 2
Unknown
16
2023-03
Ziconotide as First-Line IDT
Albany Medical College · Neuropathic Pain
Phase 4
Completed
13
2021-01
Intrathecal Ziconotide Antalgic Efficacy for Severe Refractory Neuropathic
Hospices Civils de Lyon · Severe Refractory Neuropathic Pain · Spinal Cord Lesions
Phase 3
Unknown
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2019-05
Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.
Eisai Limited · Pain Management · Severe Chronic Pain
Not applicable
Completed
219
2018-10
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