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

Zalicus1 site in 1 country144 target enrollmentDecember 2012

InterventionsZ160 Placebo

Overview

Phase: Phase 2
Intervention: Z160
Conditions: Postherpetic Neuralgia
Sponsor: Zalicus
Enrollment: 144
Locations: 1
Primary Endpoint: Change from baseline to Week 6 in the weekly average pain score based on Pain Intensity-Numeric Rating Scale (PI-NRS)
Status: Completed
Last Updated: 12 years ago

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

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

November 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Zalicus

Responsible Party

Sponsor

•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.

•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).

375 mg BID

Intervention: Z160

matching placebo control

Intervention: Placebo

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

Time Frame: Baseline to Week 6

Neuropathic Pain Scale (NPS)(Baseline to Weeks 1, 2, 4, 6)
Short Form 36 (SF-36)(Baseline to Week 6)
Z160 plasma concentrations(Baseline to Weeks 1, 2, 4, 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)
Change from baseline in weekly average pain score(Baseline to Weeks 1, 2, 3, 4, 5, 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)
Time to a >= 30% reduction in weekly average pain score(Baseline to Weeks 1, 2, 3, 4, 5, 6)
Subjects who have >= 50% reduction in average daily pain score(Baseline to Week 6)
Safety and tolerability(Baseline to Weeks 1- 12)
Amount of rescue medication used(Baseline to Weeks 1, 2, 4 and 6)