Clinical trial NCT01757873 (phase 2, status: completed)
Conditions: postherpetic neuralgia
ICD codes: B02.22
Drugs: z160, placebo
SMILES: O=C(CC(C1=CC=CC=C1)C1=CC=CC=C1)N1CCN(CC1)C(C1=CC=CC=C1)C1=CC=CC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility 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.