postherpetic neuralgia MedDRA version: 14.0 Level: PT Classification code 10036376 Term: Post herpetic neuralgia System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: EMA401 Sodium Salt
Product Code: EMA401
Pharmaceutical Form: Capsule, hard
Current Sponsor code: EMA401
Other descriptive name: sodium salt of the parent carboxylic acid which is an angi
Sponsors
Spinifex Pharmaceuticals Pty Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Be able to give voluntary written informed consent to participate in the study. 2.Be over 18 years of age. 3.Be diagnosed as suffering from PHN defined as pain persisting for more than six months after onset of herpes zoster rash. 4.Be diagnosed as suffering from moderate to severe pain across the Screening Period. The assessment of moderate and severe pain will be made using an algorithm proprietary to Spinifex Pharmaceuticals. The investigator will be informed immediately as to whether the patient is eligible or ineligible on entering all the relevant pain scores in the electronic data capture portal. 5.Willing and be able to comply with all study procedures. 6.For females, have a negative pregnancy test at the Screening visit (Visit 1) and at Visit 2 (Day 1) prior to administration of study medication. 7.For females, be of non-child-bearing potential (i.e. either surgically sterilised or one year post-menopausal), or if of child-bearing potential, must have used adequate contraceptive precautions for 30 days prior to Screening, and must agree to use two approved methods of contraception for the duration of the study, and for one month after administration of the last dose of study medication. For males: Agrees to use two approved methods of contraception for the duration of the study and until one month after administration of the last dose of the study medication. Approved methods of contraception include: •Surgical sterilization (vasectomy at least six months prior to dosing) •Condom use by male partners of female patients or by male patients. •Birth control pills, diaphragm with vaginal spermicide, intra uterine device (IUD), contraceptive hormonal patches, implants or injections by female patients or female partners of male patients 8.Be fluent in the language of the endpoint scales provided to patients in the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 104 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 68
Exclusion criteria
Exclusion criteria: 1.Be currently receiving any of the prohibited medications listed below and in Section 7.7.2 or have received within 30 days prior to the Screening visit (Visit 1) or is anticipated to receive after the start of the trial (i.e. on or after Visit 1) any new prescription systemic or topical medication for their PHN. Patients may be enrolled if stable on therapy for their PHN as specified in the permitted medications with restrictions below and in Section 7.7.1 2.Have received an investigational drug within 30 days or 10 half-lives of the drug, whichever is longer, prior to the Screening visit (Visit 1) or have previously received EMA401. 3.Known to be allergic to EMA401 or any of the excipients or who have a history of an allergic reaction to previous medication that required management by a health care professional. 4.Have a clinically significant history of systemic allergic disease (e.g., urticaria, atopic dermatitis). 5.Have a blood pressure, after resting for at least 5 minutes, outside a systolic blood pressure range of 100-150 mmHg or a diastolic blood pressure outside a range of 50-90 mmHg on two consecutive measurements (at least 10 minutes apart and completed within 20 minutes of the initial measurement). 6.Have a pulse rate, after sitting for at least 5 minutes, greater than 100 beats per minute (bpm) or lower than 50 bpm, or 45 bpm if on beta blockers, on two consecutive measurements (at least 10 minutes apart and completed within 20 minutes of the initial measurement). 7.Known to be diabetic. 8.Consume more than four units of alcohol daily for a man or three units of alcohol for a woman (one unit = 300 mL beer, one glass of wine, one measure of spirits) or has a history of alcohol abuse/dependence. 9.Have evidence of significant renal insufficiency, indicated by an estimated creatinine clearance using the Cockcroft-Gault formula of less than 50 mL/min at Screening (Visit 1). 10.Have serum aspartate transaminase (AST), gamma glutamyl transaminase (GGT) or alanine transaminase (ALT) levels greater than 3.0 x the upper limit of normal or have total bilirubin concentrations greater than 2.0 x the upper limit of normal at Screening (Visit 1). 11.Other than pain as a result of postherpetic neuralgia, have an active, uncontrolled medical condition (e.g., neurological, gastrointestinal, renal, hepatic, cardiovascular, pulmonary, metabolic, endocrine, haematological, genitourinary or other major disorder), or psychiatric illness (e.g., depression, schizophrenia), or any other significant clinical disorder or laboratory finding that in the opinion of the investigator, precludes participation in the study or may interfere with the study objectives. 12.Other than pain as a result of postherpetic neuralgia, have had a clinically significant illness or operative procedure within 4 weeks of the Screening visit (Visit 1) (e.g. influenza, myocardial infarction). 13. Have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia. 14.Have other moderate to severe pain condition that may confound the self-evaluation of pain due to postherpetic neuralgia. 15.Have skin conditions in the affected area that in the investigator’s opinion could alter sensation. 16.Have active herpes zoster upon physical examination at Screening (Visit 1) or during the study. 17.Have hepatitis B (HBV), hepatitis C (HCV) or human immunodeficiency virus (HIV) infection as defined by being seropositive for hepatitis B surface antigen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of EMA401 when administered orally, twice daily (100 mg b.i.d.), in patients with postherpetic neuralgia, as assessed by difference in mean pain intensity score compared to placebo.;Secondary Objective: 1. To evaluate the potential efficacy of EMA401 using several alternate endpoints (see efficacy parameters) 2. To evaluate the safety and tolerability of EMA401 in patients with postherpetic neuralgia 3. To evaluate the pharmacokinetics of EMA401 in patients with postherpetic neuralgia ;Primary end point(s): Efficacy: Change in mean pain intensity score (using the 11-point numerical rating scale/Likert scale) between baseline and the last week of dosing (Day 22 to 28).;Timepoint(s) of evaluation of this end point: A patient's daily pain intensity score across the preceding 24 hours will be recorded at a single timepoint in the evening prior to sleep. The daily pain intensity score will be used to calculate the mean pain intensity score at both baseline (consists of daily pain scores recorded over 7 consecutive days during the Screening Period) and across the last week (Day 22 to 28) of the Treatment Period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: 1.Onset and maintenance of effect as defined by pattern of change in the mean pain intensity score over the entire Treatment Period. 2.Proportion of patients achieving a =30% reduction in mean pain intensity score compared to baseline (i.e. responder rate). Tertiary efficacy endpoints: 1.Time to 30% decrease from baseline in mean pain intensity score 2.Quality of Life assessed by the 7-Item Pain Interference aspect of the Brief Pain Inventory (BPI) and the complete Insomnia Severity Index (ISI) [at baseline (Day 1) and Day 28] 3.Patient ratings assessed by Patient Global Impression of Change Scale (PGIC) [at Day 28] 4.Description of some of the qualities of patients’ pain (e.g. throbbing, gnawing shooting) assessed by the modified version of the Short-Form McGill Pain Questionnaire (SF-MPQ-2) [at baseline (Day 1) and Day 28] 5.Emotional and Psychological Functioning assessed by Depression Anxiety Positive Outlook Scale (DAPOS) and Pain Catastrophising Scale (PCS) [at baseline (Day 1) and Day 28] ;Timepoint(s) of evaluation of this end point: Over the entire Treatment Period. | — |
Countries
Bulgaria, Czech Republic, Serbia, South Africa, Ukraine
Contacts
Public ContactInformation Desk
Spinifex Pharmaceuticals Pty Ltd
Outcome results
None listed