Efficacy and Safety Study of Z160 in Subjects With Postherpetic Neuralgia (PHN)

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Z160 in Subjects With Postherpetic Neuralgia

This study will compare Z160 and placebo in patients with Postherpetic Neuralgia for safety and efficacy for a period of 6 weeks.

Study Overview

• Status: Completed
• Conditions: Postherpetic Neuralgia
• Intervention / Treatment: Drug: Placebo; Drug: Z160

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Investigative Site
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Investigative Site
    • Mesa, Arizona, United States, 85213
      • Investigative Site
    • Peoria, Arizona, United States, 85381
      • Investigative Site
    • Phoenix, Arizona, United States, 85020
      • Investigative Site
    • Scottsdale, Arizona, United States, 85251
      • Investigative Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Investigative Site
  • California
    • Irvine, California, United States, 92618
      • Investigative Site
    • Los Angeles, California, United States, 90033
      • Investigative Site
    • San Francisco, California, United States, 94109
      • Investigative Site
    • Thousand Oaks, California, United States, 91360
      • Investigative Site
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Investigative Site
    • Colorado Springs, Colorado, United States, 80920
      • Investigative Site
    • Denver, Colorado, United States, 80218
      • Investigative Site
  • Florida
    • Brooksville, Florida, United States, 34601
      • Investigative Site
    • Clearwater, Florida, United States, 33756
      • Investigative Site
    • Miami, Florida, United States, 33015
      • Investigative Site
    • Orlando, Florida, United States, 32806
      • Investigative Site
    • Port Orange, Florida, United States, 32127
      • Investigative Site
    • Royal Palm Beach, Florida, United States, 33411
      • Investigative Site
    • Sarasota, Florida, United States, 34243
      • Investigative Site
    • Tampa, Florida, United States, 33606
      • Investigative Site
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Investigative Site
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Investigative Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Investigative Site
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Investigative Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Investigative Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Investigative Site
    • Bay City, Michigan, United States, 48706
      • Investigative Site
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564
      • Investigative Site
  • Missouri
    • Hazelwood, Missouri, United States, 63031
      • Investigative Site
    • Kansas City, Missouri, United States, 64114
      • Investigative Site
    • St. Louis, Missouri, United States, 63117
      • Investigative Site
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • Investigative Site
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Investigative Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Investigative Site
  • New York
    • Brooklyn, New York, United States, 11235
      • Investigative Site
    • New York, New York, United States, 10016
      • Investigative Site
  • North Carolina
    • Greensboro, North Carolina, United States, 27410
      • Investigative Site
  • Ohio
    • Beavercreek, Ohio, United States, 45432
      • Investigative Site
    • Columbus, Ohio, United States, 43214
      • Investigative Site
    • Kettering, Ohio, United States, 45429
      • Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Investigative Site
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Investigative Site
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Investigative Site
    • Tullahoma, Tennessee, United States, 37388
      • Investigative Site
  • Texas
    • Austin, Texas, United States, 78731
      • Investigative Site
    • Richardson, Texas, United States, 75080
      • Investigative Site
  • Utah
    • Murray, Utah, United States, 84123
      • Investigative Site
    • Salt Lake City, Utah, United States, 84106
      • Investigative Site
  • Virginia
    • Herndon, Virginia, United States, 20171
      • Investigative Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • Investigative Site
    • Tacoma, Washington, United States, 98405
      • Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provide written informed consent.
• Either sex but must be aged >=18 years.
• Diagnosis of PHN as defined by the presence of pain in the area affected by herpes zoster >=6 months after the herpes zoster skin rash has healed.
• Pain score over the last week of >=3 and <=8 on the PI-NRS
• If female, the subject must be postmenopausal , surgically sterilized for >=3 months before the screening visit, or agree to use 2 reliable methods of contraception if of childbearing potential. If male, the subject must agree to use condoms.
• Willing and able to comply with all study procedures.

Exclusion Criteria:

• Severe pain caused by diseases other than PHN.
• Neurolytic or neurosurgical therapy for PHN within 6 months of screening (subjects who received a spinal cord stimulator implant at least 6 months before screening are eligible, but the settings need to remain stable during the double blind study period without use of a magnet).
• History of seizure, excluding pediatric febrile seizures, or currently has seizures.
• Stroke or transient ischemic attack (TIA) <=6 months before the screening visit.
• History of or a current diagnosis of schizophrenia or bipolar disorder.
• Major depressive disorder or generalized anxiety disorder <=6 months before the screening visit. Subjects who are on stable doses of selective serotonin uptake inhibitors (SSRIs) for depression (other than major depressive disorder) are eligible for the study.
• Clinically significant alcohol or substance dependency <=1 year before the screening visit
• Imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS) or had a suicide attempt within 6 months before the screening visit.
• Clinically significant conditions that, in the investigator's opinion, may interfere with the study procedures or compromise the subject's safety.
• Malignancy (other than nonmetastatic basal or squamous cell carcinoma of the skin or carcinoma in situ of other organs that was surgically removed >1 year before screening and has not recurred).
• Condition that is known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
• Illness within 30 days before screening.
• History of hypersensitivity to calcium channel blockers.
• Multiple drug allergies
• Opioids (at doses exceeding the equivalent of 15 mg of oral morphine) or a high-dose capsaicin patch (Qutenza) <=30 days before the screening visit.
• Moderate or strong cytochrome P450 inducer within 30 days before the screening visit.
• Digoxin or prohibited medications that cannot be discontinued before randomization.
• Other exclusions apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Z160; 375 mg BID	Drug: Z160
PLACEBO_COMPARATOR: Placebo; matching placebo control	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to Week 6 in the weekly average pain score based on Pain Intensity-Numeric Rating Scale (PI-NRS)	Baseline to Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in weekly average pain score		Baseline to Weeks 1, 2, 3, 4, 5, 6
Neuropathic Pain Scale (NPS)		Baseline to Weeks 1, 2, 4, 6
Patient Global Impression of Change (PGIC)		Baseline to Week 6
Profile of Mood States (POMS)		Baseline to Weeks 1, 2, 4, 6
Daily Sleep Interference Scale (DSIS)		Baseline to Weeks 1, 2, 3, 4, 5, 6
Short Form 36 (SF-36)		Baseline to Week 6
Z160 plasma concentrations		Baseline to Weeks 1, 2, 4, 6
Time to a >= 30% reduction in weekly average pain score		Baseline to Weeks 1, 2, 3, 4, 5, 6
Time to a >= 50% reduction in weekly average pain score		Baseline to Weeks 1, 2, 3, 4, 5, 6
Subjects who have >= 30% reduction in average daily pain score		Baseline to Week 6
Subjects who have >= 50% reduction in average daily pain score		Baseline to Week 6
Safety and tolerability	As measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events	Baseline to Weeks 1- 12
Amount of rescue medication used		Baseline to Weeks 1, 2, 4 and 6

Collaborators and Investigators

• Sponsor: Zalicus

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: December 7, 2012
• First Submitted That Met QC Criteria: December 21, 2012
• First Posted (ESTIMATE): December 31, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 12, 2013
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic
• Other Study ID Numbers: Z160-PHN-202