Efficacy and Safety Study of Z160 in Subjects With Postherpetic Neuralgia

NCT01757873 | Completed Phase 2 DMC

• 1 other identifier: Z160-PHN-202
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 53

Brief Summary

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

Conditions

Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

Study Arms (2)

Z160

EXPERIMENTAL

375 mg BID

Drug: Z160

Placebo

PLACEBO COMPARATOR

matching placebo control

Drug: Placebo

Interventions

Z160 DRUG

Z160

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zalicus: lead

Study Sites (53)

Investigative Site

Birmingham, Alabama, 35216, United States

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Investigative Site

Chandler, Arizona, 85224, United States

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Mesa, Arizona, 85213, United States

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Peoria, Arizona, 85381, United States

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Phoenix, Arizona, 85020, United States

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Scottsdale, Arizona, 85251, United States

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Little Rock, Arkansas, 72205, United States

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Irvine, California, 92618, United States

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Los Angeles, California, 90033, United States

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San Francisco, California, 94109, United States

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Thousand Oaks, California, 91360, United States

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Boulder, Colorado, 80304, United States

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Colorado Springs, Colorado, 80920, United States

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Denver, Colorado, 80218, United States

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Brooksville, Florida, 34601, United States

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Clearwater, Florida, 33756, United States

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Miami, Florida, 33015, United States

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Orlando, Florida, 32806, United States

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Port Orange, Florida, 32127, United States

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Royal Palm Beach, Florida, 33411, United States

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Sarasota, Florida, 34243, United States

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Tampa, Florida, 33606, United States

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Chicago, Illinois, 60602, United States

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Evansville, Indiana, 47714, United States

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Shreveport, Louisiana, 71105, United States

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Columbia, Maryland, 21045, United States

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Boston, Massachusetts, 02131, United States

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Ann Arbor, Michigan, 48104, United States

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Bay City, Michigan, 48706, United States

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Ocean Springs, Mississippi, 39564, United States

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Hazelwood, Missouri, 63031, United States

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Kansas City, Missouri, 64114, United States

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St Louis, Missouri, 63117, United States

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Omaha, Nebraska, 68124, United States

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Toms River, New Jersey, 08755, United States

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Albuquerque, New Mexico, 87102, United States

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Brooklyn, New York, 11235, United States

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New York, New York, 10016, United States

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Greensboro, North Carolina, 27410, United States

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Beavercreek, Ohio, 45432, United States

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Columbus, Ohio, 43214, United States

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Kettering, Ohio, 45429, United States

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Oklahoma City, Oklahoma, 73112, United States

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Charleston, South Carolina, 29407, United States

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Nashville, Tennessee, 37205, United States

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Tullahoma, Tennessee, 37388, United States

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Austin, Texas, 78731, United States

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Richardson, Texas, 75080, United States

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Murray, Utah, 84123, United States

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Salt Lake City, Utah, 84106, United States

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Herndon, Virginia, 20171, United States

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Bellevue, Washington, 98007, United States

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Investigative Site

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Z160

Condition Hierarchy (Ancestors)

Neuralgia; 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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 31, 2012
• Study Start: December 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

US (53)