An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||AN OPEN-LABEL EXTENSION STUDY OF DS-5565 FOR 52 WEEKS IN PAIN ASSOCIATED WITH FIBROMYALGIA|
- Number of subjects experiencing adverse events as a measure of safety [ Time Frame: Day 0 to week 52. ]Number of subjects experiencing adverse events as a measure of safety including severity of event.
- number of subjects experiencing an abnormal value of a clinical laboratory test [ Time Frame: Day 0 to week 52 ]Subjects with abnormal values will be identified in hematology, serum chemistry, and urinalysis parameters.
- Changes from baseline to scheduled timepoint in Average Daily Pain Score (ADPS). [ Time Frame: week 0 (baseline) to week 52 ]Subjects will record their worst pain over the previous 24 hours in an electronic diary using an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Pain diary scores will be recorded by the subjects during the 7 days prior to Visit 11 (Week 13), Visit 14 (Week 24), Visit 17 (Week 36), Visit 20 (Week 48), and Visit 21 (Week 52).
- Changes from baseline to scheduled timepoint in Average Daily Sleep Interference Score (ADSIS). [ Time Frame: week 0 (baseline) to week 52 ]Pain-associated sleep interference will be assessed using electronic diaries using an 11 point numeric rating scale (NRS) ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep, unable to sleep). The sleep interference NRS is a tool used to assess how pain has interfered with sleep during the past 24 hours. Sleep interference scores will be recorded by the subjects during the 7 days prior to Visit 11 (Week 13), Visit 14 (Week 24), Visit 17 (Week 36), Visit 20 (Week 48), and Visit 21 (Week 52).
- Proportion of subjects with improvement in overall status at Week 52 as assessed by Patient Global Impression of Change (PGIC). [ Time Frame: week 0 (baseline) to week 52 ]This instrument shows pain intensity in the setting of chronic pain. The 7-point PGIC measures change in the subject's overall status using the following categorical scale: 1) very much improved, 2) much improved, 3) minimally improved, 4) no change, 5) minimally worse, 6) much worse, and 7) very much worse.
- Changes from baseline to Week 52 in Hospital Anxiety Depression Scale (HADS) depression and anxiety scores [ Time Frame: week 0 (baseline) to week 52 ]The HADS questionnaire is a 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 to 21, where higher scores indicate greater severity.
- Changes in EuroQol-Instrument 5 Dimensions (EQ-5D). [ Time Frame: week 0 (baseline) to Week 52 ]The EQ-5D is an instrument that shows high construct validity and responsiveness in patients with chronic pain and has been used specifically in FM. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that are combined into an overall health utilities index, and an NRS (100 mm VAS) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health.
- Changes in Short Form 36 (SF-36) parameters [ Time Frame: week 0 (baseline) to Week 52 ]The SF-36 is a health survey that asks 36 questions to measure functional health and well-being from the subject's point of view. It is a measure of physical and mental health used across various disease areas, including FM. The SF-36 provides scores for 8 health domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) as well as psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.
- number of subjects experiencing changes in physical examinations [ Time Frame: Day 0 to Week 52 ]A full physical examination, with the exception of pelvis, breast, and rectum in women and the genitourinary system and prostate in men, will be performed at the Screening visit for de novo subjects or at the Start-of-Treatment visit for rollover subjects and at the End-of-Treatment/Early Termination visit for all subjects.
- number of subjects experiencing abnormal ECGs [ Time Frame: Day 0 to Week 52 ]A 12-lead electrocardiogram (ECG) will be conducted at the Screening visit for de novo subjects or at Start-of-Treatment visit for rollover subjects, and at the End-of-Treatment/Early Termination visit for all subjects. ECG recordings will be assessed as normal or abnormal, and any abnormal findings should be assessed as clinically significant or not clinically significant .
- number of subjects experiencing suicidal ideation or behavior as identified using the C-SSRS [ Time Frame: Day 0 to Week 52 ]The Columbia-Suicide Severity Rating Scale (C-SSRS) is an instrument that was developed to assess the severity of and monitor changes in suicidal ideation and behavior. Four constructs are measured; severity of ideation, intensity of ideation, behavior, and lethality.
- number of subjects experiencing a withdrawal symptom as identified in the PWC. [ Time Frame: Day 0 to Week 52 ]
The Physician Withdrawal Checklist (PWC) rates 20 common symptoms of withdrawal. The symptoms measured are based on those that are potentially related to benzodiazepine withdrawal: somatic, mood, cognitive, fatigue, and gastrointestinal.
Each of the 20 individual items on the PWC are rated as not present, mild, moderate, or severe.
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||August 2017|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Experimental: DS-5565 once daily
15mg DS-5565 administered once daily at bedtime
|Drug: 15mg DS-5565|
Experimental: DS-5565 twice daily
15mg DS-5565 administered twice daily
|Drug: 15mg DS-5565|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02234583
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