- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01992562
Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy
September 14, 2018 updated by: Aaron Boster
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Columbus, Ohio, United States, 43221
- The Ohio State University Department of Neurology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
5 mcg ziconotide in 1ml of normal saline bolus intrathecal injection
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Other Names:
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Placebo Comparator: Placebo
1ml of normal saline bolus intrathecal injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
within 8 hours post injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Rating Scale of Pain (NRS)
Time Frame: within 8 hours of Injection
|
Used to measure pain intensity on a 0-10 scale.
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within 8 hours of Injection
|
Brief Pain Inventory (BPI) Scale
Time Frame: within a week of Injection
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Used to assess the severity of pain and the impact of pain on daily functions.
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within a week of Injection
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: within a week of injection
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Used to measure the quality and patterns of sleep in adults.
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within a week of injection
|
Patient Global Impression of Change (PGIC)
Time Frame: within 8 hours of injection
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Used to assess the patient's belief about the efficacy of their treatment.
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within 8 hours of injection
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed 25 Foot Walk Test (T25-FW)
Time Frame: within 8 hours of injection
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A quantitative mobility and leg function performance test based on a timed 25-foot walk.
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within 8 hours of injection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aaron L Boster, MD, OhioHealth
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
November 19, 2013
First Submitted That Met QC Criteria
November 19, 2013
First Posted (Estimate)
November 25, 2013
Study Record Updates
Last Update Posted (Actual)
September 18, 2018
Last Update Submitted That Met QC Criteria
September 14, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Hematologic Diseases
- Pain
- Spinal Cord Diseases
- Bone Marrow Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Neuroprotective Agents
- Protective Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Ziconotide
Other Study ID Numbers
- PRIALT01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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