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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02187159




Registration number
NCT02187159
Ethics application status
Date submitted
8/07/2014
Date registered
10/07/2014
Date last updated
9/11/2020

Titles & IDs
Public title
Treatment of Pain Associated With Fibromyalgia
Scientific title
A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia
Secondary ID [1] 0 0
2013-005163-10
Secondary ID [2] 0 0
DS5565-A-E311
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain Associated With Fibromyalgia 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DS-5565
Treatment: Drugs - Pregabalin
Treatment: Drugs - Placebo tablet
Treatment: Drugs - Placebo capsule

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

Experimental: DS-5565 BID - Participants take one DS-5565 tablet and one placebo capsule, twice daily (BID)

Active Comparator: Pregabalin - Participants take one pregabalin capsule and one placebo tablet BID

Placebo Comparator: Placebo - Participants take one each of placebo tablet and capsule BID


Treatment: Drugs: DS-5565
DS-5565 15 mg tablet for oral administration

Treatment: Drugs: Pregabalin
Pregabalin 150 mg capsule for oral administration

Treatment: Drugs: Placebo tablet
Placebo tablet (matching DS5565) for oral administration

Treatment: Drugs: Placebo capsule
Placebo capsule (matching pregabalin) for oral administration

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or Placebo - The patient reported pain intensity daily (over the past 24 hours) on a scale of 0 = no pain to 10 = worst possible pain. The daily pain scores were averaged over 7 days to calculate the weekly ADPS.
Timepoint [1] 0 0
Baseline up to Week 13 postdose
Secondary outcome [1] 0 0
Number of Participants Who Answered "Much Improved or Better" on the Patient Global Impression of Change (PGIC) Scale at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo - Patient-rated global impression of change (PGIC) on a categorical scale from 1 = very much improved to 7 = very much worse. The number of participants with "much improved or better" (=2 scores) are reported.
Timepoint [1] 0 0
Week 13 postdose
Secondary outcome [2] 0 0
Change From Baseline to Week 13 in Fibromyalgia Index Questionnaire (FIQ) Total Score 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. Final 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.
Timepoint [2] 0 0
Baseline up to Week 13 postdose
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Week 13 postdose
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline up to Week 13 postdose
Secondary outcome [5] 0 0
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).
Timepoint [5] 0 0
Baseline up to Week 13 postdose
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Baseline up to Week 13 postdose
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Baseline up to Week 13 postdose
Secondary outcome [8] 0 0
Change From Baseline to Week 13 in Average Daily Sleep Interference Score (ADSIS) 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.
Timepoint [8] 0 0
Baseline up to Week 13 postdose
Secondary outcome [9] 0 0
The 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), sleep quantity scale (1 item) were determine. Most subscales range from 0 to 100, where higher scores indicate more of the concept being measured (eg., higher sleep disturbance scores indicate greater sleep disturbances).
Timepoint [9] 0 0
Week 13 postdose
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
Baseline up to Week 13 postdose
Secondary outcome [11] 0 0
Proportion of Days a Rescue Medication Was Used in 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).
Timepoint [11] 0 0
Week 1 to Week 13 postdose

Eligibility
Key inclusion criteria
- Age = 18 years

- Able to give written informed consent

- Able to complete subject-reported questionnaires per the investigator's judgment

- At screening, subjects must meet the 1990 American College of Rheumatology (ACR)
criteria for 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

- Subjects 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.

- Subjects 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

- Subject 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 (a2d) 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.

- Subjects 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 subjects documented to have Gilbert's syndrome may be
enrolled.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
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- Southport
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- Woodsville
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- Hobart
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- Clayton
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- Malvern East
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- Camperdown
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2194 - Campsie
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2450 - Coffs Harbour
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- St. Leonards
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4215 - Southport
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- Woodsville
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7000 - Hobart
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- Clayton
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3145 - Malvern East
Recruitment outside Australia
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Yaroslav
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Slovakia
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Banska Bystrica
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Bratislava
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Dubnica Nad Vahom
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Galanta
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Presov
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United Kingdom
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Berkshire
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Cornwall
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Derbyshire
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Dorset
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Essex
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Lancashire
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Manchester
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Merseyside
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South Yorkshire
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Staffordshire
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Tyne and Wear
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Warwickshire
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WEST Midlands
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Belfast
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Leeds
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Torpoint

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Daiichi Sankyo, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Syneos Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The main objective of this trial is to compare change in weekly average daily pain score
(ADPS) from baseline to Week 13 in participants 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.
Trial website
https://clinicaltrials.gov/show/NCT02187159
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Leader
Address 0 0
Daiichi Sankyo, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications