Ziconotide as First-Line IDT

NCT03321955 | Completed Phase 4 FDA Drug

• 1 other identifier: Jazz Prospective
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS)

  This scale allows the subject to quantify their pain numerically, with 10 being the worst pain imaginable. This scale describe subject reported pain at its worst and best in the week prior to reporting, as well as total pain on average, and at the time of documentation. The mean of these scores will be used as the primary outcome. This scale also includes a question of subject experienced global improvement in which the patient is asked to quantify their overall change in pain with 0 being no change and 10 being completely changed. Using the NRS we will calculate a responder rate, assessing percentage of patients with a 50% response in NRS

  Baseline, 3, 4, 6, 8, 9, 10, 12 week and 4, 5, 6 and 12 months

Secondary Outcomes (5)

• Oswestry Disability Index Scale

  Baseline, 12 weeks, 6 month, 12 month

• SF (Short Form) - 36

  Baseline, 12 weeks, 6 month

• IADL(Instrumental Activities of Daily Living)

  Baseline, 12 weeks, 6 month, 12 month

• Beck Depression Inventory

  Baseline, 12 weeks, 6 month, 12 month

• Pain Catastrophizing Scale

  Baseline, 12 weeks, 6 month, 12 month

Study Arms (1)

Subjects with Painful Neuropathy

EXPERIMENTAL

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.

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

Interventions

Ziconotide 100 MCG(microgram)/ML Intrathecal Solution 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.

Subjects with Painful Neuropathy

Quantitative sensory testing 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,

Subjects with Painful Neuropathy

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

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

Subjects with Painful Neuropathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical College

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Neuralgia

Interventions

ziconotide

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 26, 2017
• Study Start: November 3, 2016
• Primary Completion: August 30, 2020
• Study Completion: December 30, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

US (1)