A Study to Evaluate the Safety and Efficacy of Topically Applied TV 45070 Ointment in Patients With Postherpetic Neuralgia (PHN)
Condition: Postherpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: TV-45070; Placebo
Intervention description: TV-45070 is an ointment applied topically twice daily to area of pain.; The matching placebo ointment contained only the excipients of the active treatment; also applied topically twice daily to area of pain.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate the safety and efficacy of 4% and 8% w/w TV 45070 ointment
      compared with placebo ointment applied topically and twice daily to the area of PHN pain for
      4 weeks in patients with PHN
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has chronic Postherpetic Neuralgia (PHN), defined as pain present for more
             than 6 months and less than 10 years after onset of herpes zoster skin rash affecting
             a single dermatome. Patients with more than 1 involved dermatome may also be included,
             provided the affected dermatomes are contiguous.

          -  Patient is ≥18 years of age, with a body mass index (BMI) between 18 and 34 kg/m2,
             inclusive, at the screening visit.

          -  If the patient is a woman and is fertile, the patient is not pregnant and has negative
             pregnancy tests at both the screening and randomization visits, and agrees to use an
             acceptable method of contraception for the duration of the study, including follow-up.

          -  If the patient is a man and is capable of producing offspring, the patient must agree
             to use an acceptable method of contraception, unless the partner cannot become
             pregnant for the duration of the study, including follow-up.

          -  Patient must sign the written Informed Consent Form (ICF) for the study and be willing
             to comply with all study procedures and restrictions.

          -  Patient must be judged by the investigator to be medically healthy (except for PHN)
             and able to participate in the study

               -  Other criteria apply, please contact the investigator for more information

        Exclusion Criteria:

          -  Patient has any other severe pain that might confound assessment or self-evaluation of
             pain due to PHN.

          -  Patient has PHN affecting the face (trigeminal nerve distribution).

          -  Patient has a history, in the judgment of the investigator, of inadequate response to
             more than 3 adequate courses of treatment with other medications used to treat
             neuropathic pain (eg, tricyclic antidepressants, serotonin-norepinephrine reuptake
             inhibitors, anticonvulsants, topical lidocaine, and/or topical capsaicin).

          -  Patient is taking oral analgesics (either opioid or non-opioid) or is receiving
             topical therapy such as the 5% topical lidocaine patch for the treatment of pain and
             is unwilling or unable to complete a washout period during which the patient will
             discontinue analgesic therapy or topical pain therapy.

          -  Patient has been treated with topical capsaicin at any time in the past 6 months for
             neuropathic pain.

          -  Patient has a history of fibromyalgia.

               -  Other criteria apply, please contact the investigator for more information