Postherpetic Neuralgia
Conditions
Brief summary
This study will compare Z160 and placebo in patients with Postherpetic Neuralgia for safety and efficacy for a period of 6 weeks.
Interventions
DRUGZ160
DRUGPlacebo
Sponsors
Zalicus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic Pain Scale (NPS) | Baseline to Weeks 1, 2, 4, 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 | — |
| Short Form 36 (SF-36) | Baseline to Week 6 | — |
| Z160 plasma concentrations | Baseline to Weeks 1, 2, 4, 6 | — |
| Change from baseline in weekly average pain score | Baseline to Weeks 1, 2, 3, 4, 5, 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 | — |
| 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 | — |
| Time to a >= 30% reduction in weekly average pain score | Baseline to Weeks 1, 2, 3, 4, 5, 6 | — |
Countries
United States
Outcome results
None listed