Efficacy and Safety Study of Z160 in Subjects With Postherpetic Neuralgia

Postherpetic Neuralgia Clinical Trial

— PHN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757873
• Other study ID #: Z160-PHN-202
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2012
• Last updated: December 11, 2013
• Start date: December 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Zalicus
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

Drug:
• Z160

• Placebo

Locations

Country	Name	City	State
United States	Investigative Site	Albuquerque	New Mexico
United States	Investigative Site	Ann Arbor	Michigan
United States	Investigative Site	Austin	Texas
United States	Investigative Site	Bay City	Michigan
United States	Investigative Site	Beavercreek	Ohio
United States	Investigative Site	Bellevue	Washington
United States	Investigative Site	Birmingham	Alabama
United States	Investigative Site	Boston	Massachusetts
United States	Investigative Site	Boulder	Colorado
United States	Investigative Site	Brooklyn	New York
United States	Investigative Site	Brooksville	Florida
United States	Investigative Site	Chandler	Arizona
United States	Investigative Site	Charleston	South Carolina
United States	Investigative Site	Chicago	Illinois
United States	Investigative Site	Clearwater	Florida
United States	Investigative Site	Colorado Springs	Colorado
United States	Investigative Site	Columbia	Maryland
United States	Investigative Site	Columbus	Ohio
United States	Investigative Site	Denver	Colorado
United States	Investigative Site	Evansville	Indiana
United States	Investigative Site	Greensboro	North Carolina
United States	Investigative Site	Hazelwood	Missouri
United States	Investigative Site	Herndon	Virginia
United States	Investigative Site	Irvine	California
United States	Investigative Site	Kansas City	Missouri
United States	Investigative Site	Kettering	Ohio
United States	Investigative Site	Little Rock	Arkansas
United States	Investigative Site	Los Angeles	California
United States	Investigative Site	Mesa	Arizona
United States	Investigative Site	Miami	Florida
United States	Investigative Site	Murray	Utah
United States	Investigative Site	Nashville	Tennessee
United States	Investigative Site	New York	New York
United States	Investigative Site	Ocean Springs	Mississippi
United States	Investigative Site	Oklahoma City	Oklahoma
United States	Investigative Site	Omaha	Nebraska
United States	Investigative Site	Orlando	Florida
United States	Investigative Site	Peoria	Arizona
United States	Investigative Site	Phoenix	Arizona
United States	Investigative Site	Port Orange	Florida
United States	Investigative Site	Richardson	Texas
United States	Investigative Site	Royal Palm Beach	Florida
United States	Investigative Site	Salt Lake City	Utah
United States	Investigative Site	San Francisco	California
United States	Investigative Site	Sarasota	Florida
United States	Investigative Site	Scottsdale	Arizona
United States	Investigative Site	Shreveport	Louisiana
United States	Investigative Site	St. Louis	Missouri
United States	Investigative Site	Tacoma	Washington
United States	Investigative Site	Tampa	Florida
United States	Investigative Site	Thousand Oaks	California
United States	Investigative Site	Toms River	New Jersey
United States	Investigative Site	Tullahoma	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Zalicus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from baseline in weekly average pain score		Baseline to Weeks 1, 2, 3, 4, 5, 6	No
Secondary	Neuropathic Pain Scale (NPS)		Baseline to Weeks 1, 2, 4, 6	No
Secondary	Patient Global Impression of Change (PGIC)		Baseline to Week 6	No
Secondary	Profile of Mood States (POMS)		Baseline to Weeks 1, 2, 4, 6	No
Secondary	Daily Sleep Interference Scale (DSIS)		Baseline to Weeks 1, 2, 3, 4, 5, 6	No
Secondary	Short Form 36 (SF-36)		Baseline to Week 6	No
Secondary	Z160 plasma concentrations		Baseline to Weeks 1, 2, 4, 6	No
Secondary	Time to a >= 30% reduction in weekly average pain score		Baseline to Weeks 1, 2, 3, 4, 5, 6	No
Secondary	Time to a >= 50% reduction in weekly average pain score		Baseline to Weeks 1, 2, 3, 4, 5, 6	No
Secondary	Subjects who have >= 30% reduction in average daily pain score		Baseline to Week 6	No
Secondary	Subjects who have >= 50% reduction in average daily pain score		Baseline to Week 6	No
Secondary	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	Yes
Secondary	Amount of rescue medication used		Baseline to Weeks 1, 2, 4 and 6	No