Treatment of Pain Associated With Fibromyalgia

A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia

The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the participant that best describes his or her worst pain over the previous 24 hours.

Study Overview

• Status: Completed
• Conditions: Pain Associated With Fibromyalgia
• Intervention / Treatment: Drug: DS-5565; Drug: Placebo tablet; Drug: Placebo capsule; Drug: Pregabalin

• Study Type: Interventional
• Enrollment (Actual): 1293
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Burlington, Canada
  • Edmonton, Canada
  • Kentville, Canada
  • Kitchener, Canada, N2M 5N6
  • London, Canada, N5W 6A2
  • Markham, Canada, L3R 9W9
  • Mississauga, Canada, L5B 4M4
  • Newmarket, Canada, L3Y 5G8
  • Oshawa, Canada, L1H 1G6
  • Penticton, Canada
  • Pointe-Claire, Canada, H9R 3J1
  • Sarnia, Canada, N7T 4X3
  • Sherbrooke, Canada
  • Toronto, Canada, M3J 2C5
  • Vancouver, Canada
  • Winnipeg, Canada
• Czechia
  • Choceň, Czechia
  • Prague, Czechia
  • Rychnov nad Kneznou, Czechia
  • Říčany, Czechia
• Denmark
  • Aalborg, Denmark
  • Odense, Denmark
• Finland
  • Hyvinkää, Finland
  • Kokkola, Finland
• France
  • Amiens, France
  • Cubray, France
  • Elancourt, France
  • Grenoble, France
  • Paris, France
  • Saint-Étienne, France
  • Toulouse, France
• Germany
  • Bad Doberan, Germany
  • Berlin, Germany
  • Böhlen, Germany
  • Chemnitz, Germany
  • Cottbus, Germany
  • Dresden, Germany
  • Eichstätt, Germany
  • Essen, Germany
  • Fellbach, Germany
  • Frankfurt, Germany
  • Hamburg, Germany
  • Jena, Germany
  • Koeln, Germany
  • Leipzig, Germany
  • Mainz, Germany
  • Marburg, Germany
  • Munich, Germany
  • Mönchengladbach, Germany
  • Rodgau, Germany
  • Stadtroda, Germany
  • Wallerfing, Germany
  • Weinheim, Germany
  • Westerstede, Germany
  • Wiesbaden, Germany
  • Würzburg, Germany
• Netherlands
  • Beek, Netherlands
  • Leiden, Netherlands
  • Sneek, Netherlands
• Norway
  • Hamar, Norway
  • Hønefoss, Norway
  • Kløfta, Norway
  • Lier, Norway
  • Lillehammer, Norway
  • Stavanger, Norway
  • Ålesund, Norway
• Serbia
  • Belgrade, Serbia
  • Kragujevac, Serbia
  • Niš, Serbia
  • Novi Sad, Serbia
• Sweden
  • Borås, Sweden
  • Mölndal, Sweden
  • Stockholm, Sweden
• United States
  • Arizona
    • Glendale, Arizona, United States
    • Phoenix, Arizona, United States
  • California
    • Anaheim, California, United States
    • Beverly Hills, California, United States, 90211
    • Los Alamitos, California, United States, 90720
    • Newport Beach, California, United States
    • Oakland, California, United States
    • Rancho Mirage, California, United States
    • Roseville, California, United States, 95661
    • San Diego, California, United States, 92108
    • Sherman Oaks, California, United States, 91403
    • Torrance, California, United States, 90502
    • Tustin, California, United States, 92780
  • Colorado
    • Colorado Springs, Colorado, United States, 80916
    • Denver, Colorado, United States, 80209
  • Connecticut
    • Cromwell, Connecticut, United States
    • Danbury, Connecticut, United States
  • Florida
    • Boynton Beach, Florida, United States, 33472
    • Bradenton, Florida, United States
    • Brooksville, Florida, United States
    • Coral Springs, Florida, United States
    • Gainesville, Florida, United States
    • Jacksonville, Florida, United States
    • Lakeland, Florida, United States
    • Miami, Florida, United States
    • Ocala, Florida, United States
    • Orlando, Florida, United States
    • Port Orange, Florida, United States, 32129
    • Royal Palm Beach, Florida, United States
    • Saint Petersburg, Florida, United States, 33707
    • Sanford, Florida, United States
  • Georgia
    • Savannah, Georgia, United States, 31406
  • Illinois
    • Chicago, Illinois, United States, 60634
  • Indiana
    • Elwood, Indiana, United States, 46036
    • Indianapolis, Indiana, United States
  • Kansas
    • Newton, Kansas, United States, 67114
    • Wichita, Kansas, United States
  • Maryland
    • Wheaton, Maryland, United States, 20902
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
    • Fall River, Massachusetts, United States
    • Methuen, Massachusetts, United States
    • New Bedford, Massachusetts, United States
  • Michigan
    • Southfield, Michigan, United States, 48034
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
    • Hattiesburg, Mississippi, United States
  • Missouri
    • Kansas City, Missouri, United States
    • Saint Louis, Missouri, United States, 63141
    • Springfield, Missouri, United States
  • Nebraska
    • Omaha, Nebraska, United States, 68114
  • Nevada
    • Las Vegas, Nevada, United States, 89102
  • New Jersey
    • Berlin, New Jersey, United States, 08009
    • Princeton, New Jersey, United States
    • Stratford, New Jersey, United States, 08084
    • West Long Branch, New Jersey, United States
  • New York
    • Hartsdale, New York, United States, 10530
    • New York, New York, United States, 10168
    • Valley Stream, New York, United States
    • Williamsville, New York, United States, 14221
  • North Carolina
    • Charlotte, North Carolina, United States
    • Durham, North Carolina, United States
    • Greensboro, North Carolina, United States, 27410
    • High Point, North Carolina, United States, 27262
    • Raleigh, North Carolina, United States
    • Winston-Salem, North Carolina, United States
  • Ohio
    • Cincinnati, Ohio, United States
    • Middleburg Heights, Ohio, United States
    • Toledo, Ohio, United States, 43623
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
  • Oregon
    • Medford, Oregon, United States
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
    • Mechanicsburg, Pennsylvania, United States
    • Philadelphia, Pennsylvania, United States, 19152
  • South Carolina
    • Anderson, South Carolina, United States
    • Fountain Inn, South Carolina, United States
    • Greenville, South Carolina, United States, 29601
    • Summerville, South Carolina, United States, 29485
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57049
  • Tennessee
    • Tullahoma, Tennessee, United States
  • Texas
    • Allen, Texas, United States, 75013
    • Austin, Texas, United States, 78731
    • Carrollton, Texas, United States, 75007
    • Dallas, Texas, United States, 75230
    • DeSoto, Texas, United States
    • Houston, Texas, United States, 77079
    • Lubbock, Texas, United States
    • Mesquite, Texas, United States
    • Plano, Texas, United States
    • Richardson, Texas, United States, 75080
    • Sugar Land, Texas, United States
  • Utah
    • Bountiful, Utah, United States, 84010
  • Washington
    • Seattle, Washington, United States
  • West Virginia
    • Morgantown, West Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years
• Able to give written informed consent
• Able to complete participant-reported questionnaires per the investigator's judgment
• At screening, participants must meet the 1990 American College of Rheumatology (ACR) criteria for fibromyalgia (FM), i.e. widespread pain present for at least 3 months and pain in at least 11 of 18 specific tender point sites. In addition, the 2010 ACR criteria must be met:
• Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5, or WPI 3 to 6 and SS scale score ≥ 9
• Symptoms have been present at a similar level for at least 3 months
• The subject does not have a disorder that would otherwise explain the pain
• ADPS of ≥ 4 on the 11-point numeric rating scale (NRS) over the past 7 days prior to randomization (based on completion of at least 4 daily pain diaries during the 7-day baseline period prior to randomization)
• Subject must have documented evidence of a fundoscopic examination (with pupil dilation) within 12 months prior to screening or at screening.
• Women of child-bearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy during the study and for 4 weeks after study completion.

Exclusion Criteria:

• Clinically significant unstable neurologic, psychiatric, ophthalmologic, hepatobiliary, respiratory, or hematologic illness or unstable cardiovascular disease (e.g. severe hypotension, uncontrolled cardiac arrhythmia, or myocardial infarction) or any other concurrent disease within 12 months prior to screening that in the opinion of the investigator would interfere with study participation or assessment of safety and tolerability
• Anticipation of initiation or significant change to normal daily exercise routines or need for ongoing use of concomitant medications or non-pharmacological pain management techniques that may confound assessments of efficacy and/or safety
• Unable to undergo pre-study washout of prohibited concomitant medications
• Subjects who are at risk of suicide as defined by their responses to the Columbia-Suicide Severity Rating Scale (C-SSRS) or in the opinion of the investigator. Note: Patients answering "yes" to any of the questions about active suicidal ideation/intent/behaviors occurring within the past 12 months must be excluded (C-SSRS Suicide Ideation section - Questions 3, 4, or 5; C-SSRS Suicidal Behavior section, any of the suicide behaviors questions). Such patients should be referred immediately to a mental health professional for appropriate evaluation.
• Current severe or uncontrolled major depressive disorder or anxiety disorders as assessed by the Mini-international Neuropsychiatric Interview (MINI) mild to moderate major depression or anxiety disorders are permitted provided that the investigator assesses the patient as clinically stable and appropriate for entry into the study.
• Any diagnosis of lifetime bipolar disorder or psychotic disorder
• Participants with pain due to other conditions (e.g. diabetic peripheral neuropathic pain or post-herpetic neuralgia) that in the opinion of the investigator, would confound assessment or self-evaluation of the pain associated with FM.
• Participants with pain due to any widespread inflammatory musculoskeletal disorder (e.g. rheumatoid arthritis, lupus) or widespread rheumatic disease other than FM.
• Abuse or dependence of prescription medications, street drugs, or alcohol within the last 1 year
• Any history of a malignancy other than basal cell carcinoma within the past 5 years
• A diagnosis of untreated sleep apnea or initiation of treatment for sleep apnea within the past 3 months
• Pregnancy or breast-feeding, or intent to become pregnant during the study period
• Participant is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents.
• Known hypersensitivity to alpha2-delta (α2δ) ligands or other components of the study medications. Note: Prior exposure to DS-5565 is allowed, as long as hypersensitivity to DS-5565 was not observed.
• Participants who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the investigator to be unlikely to complete the study.
• Abnormal investigative tests (i.e. electrocardiograms [ECGs]) and laboratory values judged by the investigator to be clinically significant at screening, with particular focus on: a. Abnormal renal function defined as calculated creatinine clearance (CrCl) < 60 mL/min determined by the central laboratory using the modified Cockcroft-Gault equation; blood urea nitrogen> 1.5 × upper limit of normal (ULN); creatine kinase > 3.0 × ULN; serum creatinine > 1.6 mg/dL (> 141.4 μmol/L); b. Abnormal liver function defined as aspartate aminotransferase (AST) > 2.0 × ULN, alanine aminotransferase (ALT) > 2.0 × ULN; alkaline phosphatase > 1.5 × ULN; total bilirubin> 1.2 × ULN. If a subject has total bilirubin > 1.2 ULN, unconjugated and conjugated bilirubin fractions should be analyzed and only participants documented to have Gilbert's syndrome may be enrolled.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DS-5565 QD; Participants take one each of placebo tablet and capsule in the morning, and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening	Drug: DS-5565; DS-5565 15 mg tablet for oral administration; Other Names: mirogabalin; Drug: Placebo tablet; Placebo tablet (matching DS-5565) for oral administration; Other Names: Placebo matching DS-5565; Drug: Placebo capsule; Placebo capsule (matching pregabalin) for oral administration; Other Names: Placebo matching pregabalin
EXPERIMENTAL: DS-5565 BID; Participants take one DS-5565 tablet and one placebo capsule, twice daily (BID)	Drug: DS-5565; DS-5565 15 mg tablet for oral administration; Other Names: mirogabalin; Drug: Placebo capsule; Placebo capsule (matching pregabalin) for oral administration; Other Names: Placebo matching pregabalin
ACTIVE_COMPARATOR: Pregabalin; Participants take one pregabalin capsule and one placebo tablet BID	Drug: Placebo tablet; Placebo tablet (matching DS-5565) for oral administration; Other Names: Placebo matching DS-5565; Drug: Pregabalin; Pregabalin 150 mg capsule for oral administration; Other Names: Lyrica
PLACEBO_COMPARATOR: Placebo; Participants take one each of placebo tablet and capsule BID	Drug: Placebo tablet; Placebo tablet (matching DS-5565) for oral administration; Other Names: Placebo matching DS-5565; Drug: Placebo capsule; Placebo capsule (matching pregabalin) for oral administration; Other Names: Placebo matching pregabalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Weekly Average Daily Pain Score (ADPS) at Week 13 in Participants Receiving DS-5565, Pregabalin, Placebo	Average daily pain scores (ADPS) reported by the participant that best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale where 0 = no pain to 10 = worst possible pain. Higher scores indicate a worse outcome. For participants with no Week 13 data, the baseline observation was carried forward (BOCF). The mean (multiple imputation estimate) and standard error (multiple imputation) are reported.	Baseline up to Week 13 postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Days a Rescue Medication Was Used Among Participants Receiving DS-5565, Pregabalin, or Placebo	Proportion of days with rescue medication intake during the double-blind treatment period equals number of days with rescue medication intake/(date of last study drug administration in the double-blind treatment period) - (date of first study drug administration + 1).	Week 1 to Week 13 postdose
Number of Participants Who Answered "Much Improved or Better" in Patient Global Impression of Change (PGIC) at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo	Patient global impression of change (PGIC) on a 7-point categorical scale, where 1 = very much improved and 7 = very much worse. Higher scores indicate worse outcomes. The number of participants with 'much improved or better' status (≤2) is being reported.	Baseline up Week 13 postdose
Change in Fibromyalgia Index Questionnaire (FIQ) Total Score From Baseline to Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo	The total FIQ score is composed of 10 items, with a maximum possible score of 100. The first item contains 11 questions related to physical functioning and are rated on a 4-point Likert-type scale, where 0 indicates 'always' and 3 indicates 'never'. The overall impact items are rated on a 0-7 scale for the number of days that the patient felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. The symptoms items are rated on visual analog scales (0-10 cm), with higher numbers indicated greater symptomatology. Scores range from 0 (no impairment) to 10 (maximum impairment), where higher scores indicate worse outcome. For this outcome, the change in total FIQ score from baseline is being reported. Negative values indicate improvement from baseline in impairment.	Baseline up to Week 13 postdose
Number of Responders at Week 13 Among Participants Receiving DS-5565, Pregabalin, or Placebo	The number of participants with at least a 30% or 50% reduction in average daily pain score (ADPS) at Week 13 is reported.	Week 13 postdose
Change From Baseline to Week 13 in Multidimensional Fatigue Inventory (MFI-20) General Fatigue Score in Participants Receiving DS-5565, Pregabalin, or Placebo	MFI is a validated 20-item, self-reported instrument designed to measure fatigue in the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The respondent is asked to mark an 'X' in 1 of 5 boxes arranged linearly where 1 is 'Yes, that is true' and 5 is 'No, that is not true.' Each subscale consists of 4 items, 2 indicative for fatigue and 2 contraindicative. For the indicative questions, a high score indicates a high fatigue level and low scores indicate a low fatigue levels. Conversely, for the contraindicative questions a high score indicates a low fatigue level and a low score indicates a high fatigue level. Overall, respondents are rated on a scale of 0 (no fatigue) to 7 (high fatigue). For this outcome, the change from baseline in MFI-20 general fatigue subscale score is being reported. Negative values indicate an improvement in fatigue.	Baseline up to Week 13 postdose
Change From Baseline to Week 13 in Hospital Anxiety and Depression Scale (HADS) in Participants Receiving DS-5565, Pregabalin, or Placebo	The HADS questionnaire is a reliable, widely-used self-assessment scale to assess symptoms of anxiety and depression. The instrument consists of 7 questions related to anxiety and 7 related to depression, each rated on a 4-point scale (score of 0 to 3). Scores for anxiety and depression are independently summed to compute HADS Anxiety and HADS-Depression subscale scores, with ranges from 0 (no anxiety/depression) to 21 (most severe anxiety/depression).	Baseline up to Week 13 postdose
Change From Baseline to Week 13 in Short Form 36 (SF-36) in Participants Receiving DS-5565, Pregabalin, or Placebo	The SF-36 is a 36-question health survey that measures functional health and well-being from the participant's point of view. It is a measure of physical and mental health used across various disease areas, including fibromyalgia. The SF-36 scale ranges from 0 to 100 where lower scores indicate more disability (worse health) and higher scores represent less disability (better health). The physical component summary (PCS) and mental component summary (MCS) scores are reported.	Baseline up to Week 13 postdose
Change From Baseline to Week 13 in EuroQol Five Dimensions Questionnaire (EQ-5D) in Participants Receiving DS-5565, Pregabalin, or Placebo	The EQ-5D is an instrument that shows high construct validity and responsiveness in patients with chronic pain and has been used specifically in fibromyalgia. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with a scale that ranges from 0 (no problems) to 5 (extreme problems). These 5 dimensions are combined into an overall health utilities index, and a numeric rating scale (100 mm visual analog scale) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health. A summary index with a maximum total score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum total score of 1 indicates the best health outcome. For this outcome, the change from baseline in total EQ-5D score is being reported. Positive values indicate an improvement in health.	Baseline up to Week 13 postdose
Change From Baseline to Week 13 in Average Daily Sleep Interference in Participants Receiving DS-5565, Pregabalin, or Placebo	Pain-associated sleep interference was assessed using electronic daily diaries using an 11-point numeric rating scale (NRS) for pain, ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep, unable to sleep). ADSIS is the mean value of all available recordings of the respective week.	Baseline up Week 13 postdose
Number of Participants Reporting Optimal Sleep at Week 13 on the Medical Outcomes Study (MOS) Sleep Scale In Participants Receiving DS-5565, Pregabalin, or Placebo	The MOS Sleep Scale is a 12-item questionnaire from which the following subscales were derived: sleep disturbance (4 items), quantity of sleep/optimal sleep (1 item), snoring (1 item), awakening due to shortness of breath or due to headache (1 item), sleep adequacy (2 items), and somnolence (3 items). In addition, values for sleep disturbances index (9 items), optimal sleep scale (1 item), and sleep quantity scale (1 item) were determined. Most subscales range from 0 to 100, where higher scores indicate more of the concept begin measured (eg., higher sleep disturbance scores indicate greater sleep disturbances).	Week 13 postdose
Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo	The BPI-SF measures pain severity and interference within the past 24 hours. Items are rated on an 11-point NRS from 0 to 10, where 0 indicates does not interfere and 10 indicates completely interferes. Severity score is the average of the responses to the 4 pain intensity items that assess the Worst/Least/Average pain in the last 24 hours and the Pain Right Now. The individual items being reported (using the same scale as noted above) are Severity, General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life. Percentage relief of treatment pain scale ranges from 100% (complete pain relief) to 0% (no pain relief) and higher percentages indicate better outcome. Interference % is the average of responses for General activity, Mood, Walking ability, Normal work, Relations with other people, Sleep, Enjoyment of life where 0% (no interference) to 100% (completely interferes) and negative (ie. lower) percentages indicate better outcomes.	Baseline up to Week 13 postdose

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.
• Collaborators: Syneos Health

Publications and helpful links

General Publications

• Arnold LM, Whitaker S, Hsu C, Jacobs D, Merante D. Efficacy and safety of mirogabalin for the treatment of fibromyalgia: results from three 13-week randomized, double-blind, placebo- and active-controlled, parallel-group studies and a 52-week open-label extension study. Curr Med Res Opin. 2019 Oct;35(10):1825-1835. doi: 10.1080/03007995.2019.1629757. Epub 2019 Jul 9.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 27, 2014
• Primary Completion (ACTUAL): July 14, 2016
• Study Completion (ACTUAL): July 14, 2016

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (ESTIMATE): May 23, 2014

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: pain; fibromyalgia
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: DS5565-A-E309; 2013-005161-40 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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/
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR