Status:
COMPLETED
Ziconotide as First-Line IDT
Lead Sponsor:
Albany Medical College
Conditions:
Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to prospectively examine outcomes in 12 patients using ziconotide Intrathecal Drug Therapy(IDT) as first-line monotherapy with the use of an algorithm of slow ti...
Eligibility Criteria
Inclusion
- Must be eligible for implantation of an intrathecal analgesia programmable pump system using ziconotide IT.
- Must be 18 years of age or older for all points of data collection.
- Must be diagnosed with neuropathic pain secondary to a clear etiology. Acceptable etiologies including but not limited to diabetic neuropathy, small fiber neuropathy, and post herpetic neuropathy.
Exclusion
- Must not have or been previously implanted with a programmable pump system.
- Untreated mental illness including depression or anxiety determined by preoperative psychological evaluation.
- Active substance abuse determined by preoperative urine drug screen.
- Unwillingness to decrease oral medications at screening.
- Any prior use of intrathecal analgesia besides trialing
Key Trial Info
Start Date :
November 3 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03321955
Start Date
November 3 2016
End Date
December 30 2020
Last Update
January 12 2021
Active Locations (1)
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1
Albany Medical College
Albany, New York, United States, 12208