Clinical trial NCT01757873: Efficacy and Safety Study of Z160 in Subjects With Postherpetic Neuralgia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Lead sponsor: Zalicus
Sponsor class: INDUSTRY
First posted: 2012-12-31
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline to Week 6 in the weekly average pain score based on Pain Intensity-Numeric Rating Scale (PI-NRS)
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Change from baseline in weekly average pain score
timeFrame: Baseline to Weeks 1, 2, 3, 4, 5, 6
measure: Neuropathic Pain Scale (NPS)
timeFrame: Baseline to Weeks 1, 2, 4, 6
measure: Patient Global Impression of Change (PGIC)
timeFrame: Baseline to Week 6
measure: Profile of Mood States (POMS)
timeFrame: Baseline to Weeks 1, 2, 4, 6
measure: Daily Sleep Interference Scale (DSIS)
timeFrame: Baseline to Weeks 1, 2, 3, 4, 5, 6
measure: Short Form 36 (SF-36)
timeFrame: Baseline to Week 6
measure: Z160 plasma concentrations
timeFrame: Baseline to Weeks 1, 2, 4, 6
measure: Time to a >= 30% reduction in weekly average pain score
timeFrame: Baseline to Weeks 1, 2, 3, 4, 5, 6
measure: Time to a >= 50% reduction in weekly average pain score
timeFrame: Baseline to Weeks 1, 2, 3, 4, 5, 6
measure: Subjects who have >= 30% reduction in average daily pain score
timeFrame: Baseline to Week 6
measure: Subjects who have >= 50% reduction in average daily pain score
timeFrame: Baseline to Week 6
measure: Safety and tolerability
timeFrame: Baseline to Weeks 1- 12
measure: Amount of rescue medication used
timeFrame: Baseline to Weeks 1, 2, 4 and 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigative Site
state: Alabama
city: Chandler
country: United States
facility: Investigative Site
state: Arizona
city: Mesa
country: United States
facility: Investigative Site
state: Arizona
city: Peoria
country: United States
facility: Investigative Site
state: Arizona
city: Phoenix
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facility: Investigative Site
state: Arizona
city: Scottsdale
country: United States
facility: Investigative Site
state: Arizona
city: Little Rock
country: United States
facility: Investigative Site
state: Arkansas
city: Irvine
country: United States
facility: Investigative Site
state: California
city: Los Angeles
country: United States
facility: Investigative Site
state: California
city: San Francisco
country: United States
facility: Investigative Site
state: California
city: Thousand Oaks
country: United States
facility: Investigative Site
state: California
city: Boulder
country: United States
facility: Investigative Site
state: Colorado
city: Colorado Springs
country: United States
facility: Investigative Site
state: Colorado
city: Denver
country: United States
facility: Investigative Site
state: Colorado
city: Brooksville
country: United States
facility: Investigative Site
state: Florida
city: Clearwater
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Orlando
country: United States
facility: Investigative Site
state: Florida
city: Port Orange
country: United States
facility: Investigative Site
state: Florida
city: Royal Palm Beach
country: United States
facility: Investigative Site
state: Florida
city: Sarasota
country: United States
facility: Investigative Site
state: Florida
city: Tampa
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facility: Investigative Site
state: Florida
city: Chicago
country: United States
facility: Investigative Site
state: Illinois
city: Evansville
country: United States
facility: Investigative Site
state: Indiana
city: Shreveport
country: United States
facility: Investigative Site
state: Louisiana
city: Columbia
country: United States
facility: Investigative Site
state: Maryland
city: Boston
country: United States
facility: Investigative Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Investigative Site
state: Michigan
city: Bay City
country: United States
facility: Investigative Site
state: Michigan
city: Ocean Springs
country: United States
facility: Investigative Site
state: Mississippi
city: Hazelwood
country: United States
facility: Investigative Site
state: Missouri
city: Kansas City
country: United States
facility: Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Investigative Site
state: Missouri
city: Omaha
country: United States
facility: Investigative Site
state: Nebraska
city: Toms River
country: United States
facility: Investigative Site
state: New Jersey
city: Albuquerque
country: United States
facility: Investigative Site
state: New Mexico
city: Brooklyn
country: United States
facility: Investigative Site
state: New York
city: New York
country: United States
facility: Investigative Site
state: New York
city: Greensboro
country: United States
facility: Investigative Site
state: North Carolina
city: Beavercreek
country: United States
facility: Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Investigative Site
state: Ohio
city: Kettering
country: United States
facility: Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Investigative Site
state: Oklahoma
city: Charleston
country: United States
facility: Investigative Site
state: South Carolina
city: Nashville
country: United States
facility: Investigative Site
state: Tennessee
city: Tullahoma
country: United States
facility: Investigative Site
state: Tennessee
city: Austin
country: United States
facility: Investigative Site
state: Texas
city: Richardson
country: United States
facility: Investigative Site
state: Texas
city: Murray
country: United States
facility: Investigative Site
state: Utah
city: Salt Lake City
country: United States
facility: Investigative Site
state: Utah
city: Herndon
country: United States
facility: Investigative Site
state: Virginia
city: Bellevue
country: United States
facility: Investigative Site
state: Washington
city: Tacoma
country: United States
facility: Investigative Site
state: Washington
Study officials:
References: