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| Name | Class |
|---|---|
| SRL Medisearch Inc. | INDUSTRY |
| Quintiles, Inc. | INDUSTRY |
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Investigate the efficacy and safety of DS-5565 in subjects with Post-Herpetic Neuralgia (PHN) in comparison to placebo
[Double Blind Phase] The primary objective is to compare change in the Average Daily Pain Score (ADPS) from baseline to Week 14 in Asian subjects with PHN receiving DS-5565 versus placebo.
[Open Extension Phase] The objective is to assess the long-term safety and efficacy of DS-5565 in subjects with PHN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (14-weeks) |
|
| DS-5565 15 mg Group | Experimental | DS-5565 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose |
|
| DS-5565 20 mg Group | Experimental | DS-5565 20 mg, oral administration, Treatment period; 1-week titration and 13-weeks fixed dose |
|
| DS-5565 30 mg Group | Experimental | DS-5565 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| DS-5565 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Each participant recorded a pain score in the electronic patient diary once daily from the day after the screening visit (Visit 1) to the end of treatment/early termination visit (Visit 10). Prior to taking the study drug each morning, the participant selected the number that best described his or her pain over the past 24 hours on a scale of 0 (no pain) to 10 (worst possible pain). Higher ADPS scores indicated worse outcome. ADPS was the weekly average pain score based on the pain scores from the electronic patient diaries (Pain diary). In this outcome, the change from baseline in ADPS is being reported with negative values representing improvements in average daily pain. The larger the negative value (ie. improvement), the greater the improvement in average daily pain. | Baseline to Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Visual Analog Scale (VAS) pain is a 10-point assessment tool to measure pain levels, where 0 is defined as 'no pain' and 10 is defined as 'worst possible pain'. Higher VAS pain scores indicate worse outcome. In this outcome, the change from baseline in VAS pain is being reported with negative values representing improvements in pain intensity. The larger the negative value (ie. improvement), the greater the improvement in pain intensity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daichii Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Corporation Fujigaki Clinic | Ōita | 870-0942 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34059327 | Derived | Kato J, Baba M, Kuroha M, Kakehi Y, Murayama E, Wasaki Y, Ohwada S. Safety and Efficacy of Mirogabalin for Peripheral Neuropathic Pain: Pooled Analysis of Two Pivotal Phase III Studies. Clin Ther. 2021 May;43(5):822-835.e16. doi: 10.1016/j.clinthera.2021.03.015. Epub 2021 May 29. | |
| 32899037 | Derived | Kato J, Matsui N, Kakehi Y, Murayama E, Ohwada S. Long-term safety and efficacy of mirogabalin in Asian patients with postherpetic neuralgia: Results from an open-label extension of a multicenter randomized, double-blind, placebo-controlled trial. Medicine (Baltimore). 2020 Sep 4;99(36):e21976. doi: 10.1097/MD.0000000000021976. |
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De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
This study included a double-blind phase where participants received DS-5565 (15 mg, 20 mg, or 30 mg) or placebo and an open-label extension phase where participants received DS-5565 (starting dose 5 mg).
A total of 765 participants who met all inclusion and no exclusion criteria were enrolled in the study; 763 participants received treatment in the double-blind phase. A total of 239 participants received treatment in the open-label extension phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants who received placebo for 14 weeks. |
| FG001 | DS-5565 15 mg/Day | Participants received oral administrations of DS-5565 15 mg/day with a 2 week titration (5 mg/day during 1st week and 10 mg/day during 2nd week) followed by 12 weeks fixed dose (15 mg/day). |
| FG002 | DS-5565 20 mg/Day | Participants received oral administrations of DS-5565 20 mg/day with a 1 week titration (5 mg BID) followed by 13 weeks fixed dose (10 mg BID). |
| FG003 | DS-5565 30 mg/Day | Participants received oral administrations of DS-5565 30 mg/day with a 2 week titration (5 mg BID during 1st week and 10 mg BID during 2nd week) followed by 12 weeks fixed dose (15 mg BID). |
| FG004 | DS-5565 Open-label Extension | Participants who received 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind Phase |
|
| |||||||||||||||||||||
| Open-label Extension Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants who received placebo for 14 weeks. |
| BG001 | DS-5565 15 mg | Participants who received oral administration of DS-5565 15 mg with a 2 week titration and 12 weeks fixed dose treatment period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Each participant recorded a pain score in the electronic patient diary once daily from the day after the screening visit (Visit 1) to the end of treatment/early termination visit (Visit 10). Prior to taking the study drug each morning, the participant selected the number that best described his or her pain over the past 24 hours on a scale of 0 (no pain) to 10 (worst possible pain). Higher ADPS scores indicated worse outcome. ADPS was the weekly average pain score based on the pain scores from the electronic patient diaries (Pain diary). In this outcome, the change from baseline in ADPS is being reported with negative values representing improvements in average daily pain. The larger the negative value (ie. improvement), the greater the improvement in average daily pain. | Average daily pain score (ADPS) was assessed in the modified Intent-to-Treat Analysis Set. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 14 |
|
Adverse events (AEs) were collected from after the participant signed the informed consent form and up to 7 days after the last dose of the study drug (the post-treatment follow-up visit [Visit 11]), up to 2 years 5 months.
Treatment-emergent AEs were defined as any AEs that appeared after the first administration of study treatment or that worsened relative to the pre-treatment state. Safety data were reported from participants in the Safety Analysis Set who had available safety data; 2 participants in the DS-5565 open-label extension data did not have available safety data and were not included in the analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants who received placebo for 14 weeks. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo | 908-992-6400 | CTRinfo@dsi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2016 | Aug 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000598618 | mirogabalin |
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| Drug |
|
|
| From baseline (Week 14) to Week 66 |
| Lack of Efficacy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Other |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | DS-5565 20 mg | Participants who received oral administration of DS-5565 20 mg with a 1 week titration and 13 weeks fixed dose treatment period. |
| BG003 | DS-5565 30 mg | Participants who received oral administration of DS-5565 30 mg with a 2 week titration and 12 weeks fixed dose treatment period. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Placebo | Participants who received placebo for 14 weeks. |
| OG001 | DS-5565 15 mg/Day | Participants received oral administrations of DS-5565 15 mg/day with a 2 week titration (5 mg/day during 1st week and 10 mg/day during 2nd week) followed by 12 weeks fixed dose (15 mg/day). |
| OG002 | DS-5565 20 mg/Day | Participants received oral administrations of DS-5565 20 mg/day with a 1 week titration (5 mg BID) followed by 13 weeks fixed dose (10 mg BID). |
| OG003 | DS-5565 30 mg/Day | Participants received oral administrations of DS-5565 30 mg/day with a 2 week titration (5 mg BID during 1st week and 10 mg BID during 2nd week) followed by 12 weeks fixed dose (15 mg BID). |
|
|
|
| Secondary | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Visual Analog Scale (VAS) pain is a 10-point assessment tool to measure pain levels, where 0 is defined as 'no pain' and 10 is defined as 'worst possible pain'. Higher VAS pain scores indicate worse outcome. In this outcome, the change from baseline in VAS pain is being reported with negative values representing improvements in pain intensity. The larger the negative value (ie. improvement), the greater the improvement in pain intensity. | Visual analog scale (VAS) was assessed in the modified Intent-to-Treat Analysis Set. | Posted | Mean | Standard Deviation | units on a scale | From baseline (Week 14) to Week 66 |
|
|
|
| 303 |
| 0 |
| 303 |
| 45 |
| 303 |
| EG001 | DS-5565 15 mg/Day | Participants received oral administrations of DS-5565 15 mg/day with a 2 week titration (5 mg/day during 1st week and 10 mg/day during 2nd week) followed by 12 weeks fixed dose (15 mg/day). | 0 | 152 | 0 | 152 | 44 | 152 |
| EG002 | DS-5565 20 mg/Day | Participants received oral administrations of DS-5565 20 mg/day with a 1 week titration (5 mg BID) followed by 13 weeks fixed dose (10 mg BID). | 0 | 153 | 0 | 153 | 53 | 153 |
| EG003 | DS-5565 30 mg/Day | Participants received oral administrations of DS-5565 30 mg/day with a 2 week titration (5 mg BID during 1st week and 10 mg BID during 2nd week) followed by 12 weeks fixed dose (15 mg BID). | 0 | 155 | 0 | 155 | 72 | 155 |
| EG004 | DS-5565 Open-label Extension | Participants who received 5 mg BID for the first 2 weeks and 10 mg BID for the second 2 weeks (i.e., Week 3 and 4). At Week 5, the dosage escalated to 15 mg BID if there were no concerns in safety. For the subsequent visits, the dosage may have changed to either 10 mg BID or 15 mg BID depending on safety findings. | 1 | 237 | 20 | 237 | 99 | 237 |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dissociative disorder | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Uterine fibrosis | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Large intestinal polypectomy | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
|
| Nasal polypectomy | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Week 26 |
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| Week 30 |
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| Week 34 |
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| Week 38 |
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| Week 42 |
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| Week 46 |
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| Week 50 |
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| Week 54 |
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| Week 58 |
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| Week 62 |
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| Week 66 |
|