E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054095 |
E.1.2 | Term | Neuropathic pain |
E.1.2 | System Organ Class | 100000004852 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety, tolerability, and efficacy of AGN-214868 compared with placebo in the treatment of postherpetic neuralgia (PHN). |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1- Male or female patients aged 18 to 80 years at screening 2- At visit 1, persistent PHN with pain present for at least 9 months (36 weeks) after the onset of herpes zoster skin rash affecting the cervical, thoracic, lumbar, or sacral dermatomes 3- Pain intensity rating for the past week of ≥ 4 on the 0 to 10 Weekly Pain Intensity Scale at visit 1 4- Average pain intensity score of ≥ 4 (rated 0 to 10 on the Daily Pain Intensity Scale in the patient electronic diary [eDiary]) during the baseline period (ie, days -7 to -1) 5- Maximal areas of spontaneous pain ≤ 250 cm2, inclusive of all areas of spontaneous pain, at screening (visit 1) 6-Maximal areas of spontaneous pain, inclusive of all areas os spontaneous pain, can be covered by 65 injections at randomization (visit 3) |
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E.4 | Principal exclusion criteria |
1. Use of prohibited analgesic medications for 28 days prior to initiating the baseline period through the first 12 weeks after randomization. 2. Current (within 28 days of initiation of baseline period) or anticipated treatment after initiation of baseline period through the first 12 weeks after randomization with acupuncture, spinal cord stimulation, transcutaneous nerve stimulation (TNS) over the area affected by PHN, trigger point injection in area affected by PHN, or oral or parenteral (including systemically and spinally administered) corticosteroids. 3- Beck Depression Inventory-II (BDI-II) score of > 19 (moderate to severe depressive symptoms), or a score of > 0 on BDI-II Question #9 (suicidal thoughts) 4- Active herpes zoster skin rash (at any location) at screening (visit 1) and randomization (visit 3) 5- Evidence of active skin infection or inflammation at the anticipated treatment sites at visit 3 6- Current (within 28 days of initiation of baseline period) or anticipated treatment after initiation of baseline period through the first 12 weeks after randomization with acupuncture, spinal cord stimulation, transcutaneous nerve stimulation (TNS) over the area affected by PHN, trigger point injection in area affected by PHN, or oral or parenteral (including systemically and spinally administered) corticosteroids 7- Current (within 28 days of visit 2) or anticipated use after initiation of baseline period through the first 12 weeks after randomization of topical analgesic agents (eg, lidocaine patch) in the area of PHN 8- Previous (within 6 months [24 weeks] of visit 2) or anticipated use of capsaicin (at any concentration) in the area of PHN 9- Received treatment (drug or placebo) in a previous AGN-214868 study
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy measure is the daily average pain intensity score on the daily Pain Intensity Scale and reported in the patient eDiary. The daily Pain Intensity Scale is a Likert scale rated from 0 to 10, with higher numbers indicating greater pain intensity. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
as documented in the protocol |
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E.5.2 | Secondary end point(s) |
The following is a list of secondary and additional measures that will be used for this study: Key Secondary Efficacy Measures: -- proportion of patients who are responders, who have ≥ 30 % and in 10 % increments up to 100% improvement (decrease) in average pain intensity score at each week compared with baseline. - Maximal area of spontaneous pain - Area of allodynia - Evoked pain score in the area of allodynia Key Secondary Safety Measures: - Adverse events -physical examinations -vital signs including oral body - temperature - electrocardiograms (ECGs) and - clinical laboratory tests (blood chemistry and hematology [nonfasting], urinalysis)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 39 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |