Last updated on April 2019

Dose Response Study of EMA401 in Patients With Post-herpetic Neuralgia (PHN)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Postherpetic neuralgia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • At the time of Screening, have documented diagnosis of PHN (ICD-10 code B02.29), defined as pain in the region of the rash persisting for more than 6 months after onset of herpes zoster rash.
  • Be assessed as suffering from moderate to severe neuropathic pain across the Screening epoch (NRS 4).
  • Patients must have documented past and/or ongoing inadequate treatment response (having insufficient pain relief with treatment or inability to tolerate) to at least 2 different prescribed therapies commonly used to treat and considered effective by the Investigator for the treatment of PHN.

Exclusion Criteria:

  • History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the study
  • Major depressive episode within 6 months prior to Screening and/or a history of diagnosed recurrent major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
  • Have evidence of significant renal insufficiency or pre-existing liver condition
  • Have platelets 100 x 10^9/L, or neutrophil count < 1.2 x 10^9/L (or equivalent), hemoglobin 100 g/L for women or hemoglobin 110 g/L for men.
  • Patients who have a known diagnosis of diabetes and are stable on medication with a hemoglobin A1c > 8%. Those who do not have a known diagnosis of diabetes with a hemoglobin A1c > 7%.
  • Have previously received herpes zoster vaccine
  • Patient is unwilling or unable to complete daily e-Diary

Other protocol-defined inclusion/exclusion criteria may apply.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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