Efficacy and Safety Study of Z160 in Subjects With Postherpetic Neuralgia (PHN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zalicus
ClinicalTrials.gov Identifier:
NCT01757873
First received: December 7, 2012
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Postherpetic Neuralgia
Drug: Z160
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Zalicus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in weekly average pain score [ Time Frame: Baseline to Weeks 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]
  • Neuropathic Pain Scale (NPS) [ Time Frame: Baseline to Weeks 1, 2, 4, 6 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
  • Profile of Mood States (POMS) [ Time Frame: Baseline to Weeks 1, 2, 4, 6 ] [ Designated as safety issue: No ]
  • Daily Sleep Interference Scale (DSIS) [ Time Frame: Baseline to Weeks 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]
  • Short Form 36 (SF-36) [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
  • Z160 plasma concentrations [ Time Frame: Baseline to Weeks 1, 2, 4, 6 ] [ Designated as safety issue: No ]
  • Time to a >= 30% reduction in weekly average pain score [ Time Frame: Baseline to Weeks 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]
  • Time to a >= 50% reduction in weekly average pain score [ Time Frame: Baseline to Weeks 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]
  • Subjects who have >= 30% reduction in average daily pain score [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
  • Subjects who have >= 50% reduction in average daily pain score [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Baseline to Weeks 1- 12 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline to Weeks 1, 2, 4 and 6 ] [ Designated as safety issue: No ]

Enrollment: 144
Study Start Date: December 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Z160
375 mg BID
Drug: Z160
Placebo Comparator: Placebo
matching placebo control
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757873

  Show 53 Study Locations
Sponsors and Collaborators
Zalicus
  More Information

Additional Information:
No publications provided

Responsible Party: Zalicus
ClinicalTrials.gov Identifier: NCT01757873     History of Changes
Other Study ID Numbers: Z160-PHN-202
Study First Received: December 7, 2012
Last Updated: December 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014