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
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 April 17, 2014