Efficacy and Safety Study of Z160 in Subjects With Postherpetic Neuralgia

Phase 2

Completed

• Conditions: Postherpetic Neuralgia
• Interventions: Drug: Z160; Drug: Placebo

• Registration Number: NCT01757873
• Lead Sponsor: Zalicus

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-21
• Study First Posted: 2012-12-31
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Z160	Z160	375 mg BID
Placebo	Placebo	matching placebo control

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	As measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events
Amount of rescue medication used	Baseline to Weeks 1, 2, 4 and 6

Trial Locations

Locations (1)

Investigative Site; 🇺🇸 Tacoma, Washington, United States