Ziconotide as First-Line IDT

Albany Medical College

Status and phase: Completed; Phase 4

Conditions: Neuropathic Pain

Treatments: Drug: Ziconotide 100 MCG(microgram)/ML Intrathecal Solution; Diagnostic Test: Quantitative sensory testing; Diagnostic Test: Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factor

Study type: Interventional

Funder types: Other

Identifiers

NCT03321955

Jazz Prospective

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Subjects with Painful Neuropathy

Experimental group

Description:

All subjects will be implanted with the Medtronic Synchromed II pump, and treated with the same algorithm for dose adjustment for painful neuropathy with Ziconotide 100 micrograms/ml.

Treatment:

Diagnostic Test: Quantitative sensory testing

Drug: Ziconotide 100 MCG(microgram)/ML Intrathecal Solution

Diagnostic Test: Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factor