Post-herpetic neuralgia MedDRA version: 20.0 Level: PT Classification code 10036376 Term: Post herpetic neuralgia System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Code: EMA401
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not available
CAS Number: 1316755-17-5
Current Sponsor code: EMA401
Other descriptive name: EMA401
Concentration unit: mg m
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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\Analgesics commonly used to treat and considered effective for the treatment of PHN. • Patients must be willing to complete daily eDiary. Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: • 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 unless they are using highly effective methods of contraception during dosing and for 3 days after stopping study medication. • Have evidence of significant renal insufficiency or pre-existing liver condition. • Have platelets = 100 x 10^9/L, or neutrophil count 8%. Those who do not have a known diagnosis of diabetes with a hemoglobin A1c > 7%. Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize dose response, and evaluate safety and efficacy of three different doses of EMA401 compared to placebo in patients with post-herpetic neuralgia (PHN);Secondary Objective: • To compare efficacy of EMA401 vs placebo in 24-hour average pain intensity score, using an 11 point Numeric Rating Scale (NRS) by testing the superiority of at least one active dose of EMA401 vs. placebo • To evaluate efficacy, as measured by the Brief Pain Inventory-Short Form (BPI-SF) interference total score • To evaluate efficacy, as measured by the weekly mean of the 24-hour worst pain intensity score, using an 11-point NRS • To evaluate efficacy, on the Patient Global Impression of Change (PGIC) • To evaluate proportion of patients achieving a = 30% and a = 50% reduction in weekly mean 24-hour average pain intensity score using the NRS (i.e., responder rates) • To evaluate effect on the Insomnia Severity Index (ISI) • To evaluate effect on the Neuropathic Pain Symptom Inventory (NPSI) • To evaluate safety and tolerability in PHN patients • To evaluate pharmacokinetics of EMA401 and exposure-response (decrease in pain intensity) relationship for EMA401 ;Primary end point(s): Dose-response in change in weekly mean of the 24-hour average pain score, using an 11-point Numeric Rating Scale (NRS), from Baseline to Week 12;Timepoint(s) of evaluation of this end point: Baseline, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in weekly mean 24-hour average pain score (using the 11 point Numerical Rating Scale) from Baseline to Week 12 • Change in Brief Pain Inventory-Short Form interference total score from Baseline to Week 12 • Change in weekly mean of the 24-hour worst pain score, using an 11-point NRS, from Baseline to Week 12 • Patient Global Impression of Change at Week 12 • Proportion of patients meeting responder criteria from Baseline to Week 12 • Change in Insomnia Severity Index from Baseline to Week 12 • Change in Neuropathic Pain Symptom Inventory from Baseline to Week 12 • Number and severity of treatment emergent adverse events and the frequency of adverse events leading to discontinuation. Number of serious adverse events. • Pharmacokinetics of EMA401 and exposure-response (decrease in pain intensity) relationship for EMA401;Timepoint(s) of evaluation of this end point: For full details, please refer to the schedule of assessments table in the protocol. | — |
Countries
Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hungary, Italy, Japan, Norway, Poland, Portugal, Slovakia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed