Ziconotide as First-Line IDT
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/28/2017 |
| Start Date: | November 3, 2016 |
| End Date: | January 30, 2020 |
| Contact: | Margaret M. Czerwinski, RN |
| Email: | czerwim@mail.amc.edu |
| Phone: | 518 262-0034 |
Prospective Study of Conservative Ziconotide Dosing as a First-Line Intrathecal Drug Therapy for Neuropathic Pain
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 titration for dosing. The use of Prialt has demonstrated fewer and less
serious associated adverse effects as compared to IDT morphine, especially when titrated
slowly. We will use an average Numerical Rating Scale as our primary outcome and the Oswestry
Disability Index(ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS),
Clinical Global Impression of Change Scale including binary satisfaction measures(CGIC),
Lawton-Brody Instrumental Activities of Daily Living(IADL) and Short Form-36 as secondary
outcome measures.
ziconotide Intrathecal Drug Therapy(IDT) as first-line monotherapy with the use of an
algorithm of slow titration for dosing. The use of Prialt has demonstrated fewer and less
serious associated adverse effects as compared to IDT morphine, especially when titrated
slowly. We will use an average Numerical Rating Scale as our primary outcome and the Oswestry
Disability Index(ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS),
Clinical Global Impression of Change Scale including binary satisfaction measures(CGIC),
Lawton-Brody Instrumental Activities of Daily Living(IADL) and Short Form-36 as secondary
outcome measures.
Inclusion Criteria:
1. Must be eligible for implantation of an intrathecal analgesia programmable pump system
using ziconotide IT.
2. Must be 18 years of age or older for all points of data collection.
3. 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 Criteria:
1. Must not have or been previously implanted with a programmable pump system.
2. Untreated mental illness including depression or anxiety determined by preoperative
psychological evaluation.
3. Active substance abuse determined by preoperative urine drug screen.
4. Unwillingness to decrease oral medications at screening.
5. Any prior use of intrathecal analgesia besides trialing
We found this trial at
1
site
47 New Scotland Ave
Albany, New York 12208
Albany, New York 12208
(518) 262-3125
Principal Investigator: Julie G, Pilitsis, MD, PhD
Phone: 518-262-0034
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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