Ziconotide as First-Line IDT

NCT ID: NCT03321955

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-03
• Study Completion Date: 2020-12-30

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 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.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects with Painful Neuropathy

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.

Group Type: EXPERIMENTAL

Ziconotide 100 MCG(microgram)/ML Intrathecal Solution

Intervention Type: DRUG

Initial dose at time of the implant will be 1.2 mcg/day with dose increases of no more the .4 mcg/day planned for 3, 6, 8, 9, 10, 12 weeks and 4, 5, 6 and 12 months.

Quantitative sensory testing

Intervention Type: DIAGNOSTIC_TEST

Quantitative sensory testing will be done using different types of sensory stimulation to objectively quantify sensation and pain tolerance. VonFrey fibers of various widths are used to detect sensation, a Neuropen pin prick iutilized to detect pain, along with a tuning fork to measure vibrationand a pressure guage to measure pressure felt on the skin. Cold/hot sensation is tested with Medoc Pathway system to quantitatively measure the temperature felt by patients to be done at baseline, 6 months and 12 months,

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

Intervention Type: DIAGNOSTIC_TEST

Increases in these biomarkers indicate nerve pain as they are released from macrophages in patients with damaged nerves.

Interventions

Ziconotide 100 MCG(microgram)/ML Intrathecal Solution

Initial dose at time of the implant will be 1.2 mcg/day with dose increases of no more the .4 mcg/day planned for 3, 6, 8, 9, 10, 12 weeks and 4, 5, 6 and 12 months.

Intervention Type: DRUG

Quantitative sensory testing

Quantitative sensory testing will be done using different types of sensory stimulation to objectively quantify sensation and pain tolerance. VonFrey fibers of various widths are used to detect sensation, a Neuropen pin prick iutilized to detect pain, along with a tuning fork to measure vibrationand a pressure guage to measure pressure felt on the skin. Cold/hot sensation is tested with Medoc Pathway system to quantitatively measure the temperature felt by patients to be done at baseline, 6 months and 12 months,

Intervention Type: DIAGNOSTIC_TEST

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

Increases in these biomarkers indicate nerve pain as they are released from macrophages in patients with damaged nerves.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albany Medical College

OTHER

Sponsor Role: lead

Responsible Party

Julie Pilitsis, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Albany Medical College

Albany, New York, United States

Countries

United States

Other Identifiers

Jazz Prospective

Identifier Type: -

Identifier Source: org_study_id