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Recruitment Status : Withdrawn (Logistical issues with study process and recruitment)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
|Condition or disease||Intervention/treatment||Phase|
|Painful Myelopathy Painful Neuropathy||Drug: Ziconotide Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
5 mcg ziconotide in 1ml of normal saline bolus intrathecal injection
Other Name: Prialt
Placebo Comparator: Placebo
1ml of normal saline bolus intrathecal injection
- 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.
- 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.
- 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.
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
|United States, Ohio|
|The Ohio State University Department of Neurology|
|Columbus, Ohio, United States, 43221|
|Principal Investigator:||Aaron L Boster, MD||OhioHealth|