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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02234583




Registration number
NCT02234583
Ethics application status
Date submitted
4/09/2014
Date registered
9/09/2014
Date last updated
23/07/2020

Titles & IDs
Public title
An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia
Scientific title
An Open-label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia
Secondary ID [1] 0 0
2013-005164-26
Secondary ID [2] 0 0
DS5565-A-E312
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

Experimental: DS-5565 - Participants receive 15 mg DS-5565 administered once or twice daily. Each participant's dose can be titrated up or down based on the investigator's decision. Analysis will be based on the dose modality at the time of data collection.


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

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

Outcomes
Primary outcome [1] 0 0
Average Daily Pain Score (ADPS) for DS-5565 - Average of daily pain scores are reported by the participant and best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale of 0 = no pain to 10 = worst possible pain.
Timepoint [1] 0 0
Day 0 (baseline) up to to Week 52 postdose
Secondary outcome [1] 0 0
Number of Participants With Much Improved or Better (=2) Status in Status at Week 52 As Assessed by the Patient-Rated Global Impression of Change - 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" status are reported.
Timepoint [1] 0 0
Week 52 postdose
Secondary outcome [2] 0 0
Hospital Anxiety Depression Scale (HADS) Depression and Anxiety Scores for DS-5565 - 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 from 0 to 3, where higher scores indicate greater anxiety or depression. 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.
Timepoint [2] 0 0
Day 0 (baseline) up to Week 52 postdose
Secondary outcome [3] 0 0
EuroQol Five Dimensions Questionnaire (EQ-5D) Measure for DS-5565 - 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) 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.
Timepoint [3] 0 0
Day 0 (baseline) up to Week 52 postdose
Secondary outcome [4] 0 0
Short Form-36 (SF-36) Measure for DS-5565 - 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 physical component summary and mental component summary scales range 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) total scores at baseline and Week 52 are reported.
Timepoint [4] 0 0
Day 0 (baseline) to Week 52 postdose
Secondary outcome [5] 0 0
Pain-Associated Sleep Interference as Assessed by Average Daily Sleep Interference Score (ADSIS) for DS-5565 - 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. For rollover participants, the baseline scores from the End-of-Tapering period in the preceding study are reported. For de novo participants, the baseline scores are derived from the 7 days prior to the start of treatment.
Timepoint [5] 0 0
Day 0 (baseline) up to Week 52 postdose

Eligibility
Key inclusion criteria
- Able to give written informed consent

- Completed participation (i.e. completed the End-of-Tapering visit) in a preceding
study of DS 5565 in FM (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311)

- 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

- Able to complete subject-reported questionaires per the investigator's judgement

- The subject must not have experienced any significant safety issues during the
preceding study that, in the investigator's judgment, would adversely impact the
subject's well-being in the long-term extension

De Novo Subjects

- 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
first dose (based on completion of at least 4 daily pain diaries during the 7-day
baseline period)

- 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 during the preceding study (for rollover subjects) or
within 12 months prior to screening (for de novo subjects) that in the opinion of the
investigator would interfere with study participation or assessment of safety and
tolerability

- Subjects who are at risk of suicide as defined by their responses to the C-SSRS or in
the opinion of the investigator.

- Subjects with severe or uncontrolled depression that, in the judgment of the
investigator, makes the subject inappropriate for entry into the study

- Subjects with pain due to other conditions (e.g. DPNP 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

- A diagnosis of untreated sleep apnea or initiation of treatment for sleep apnea within
the past 3 months

- Known hypersensitivity to a2d ligands or other components of the study medications

- Pregnancy or breast-feeding, or intent to become pregnant during the study period

- Abnormal investigative tests (i.e. ECGs) and laboratory values judged by the
investigator to be clinically significant at the End-of-Treatment visit (Visit - Week
13) in the preceding study (for rollover subjects) or at screening (for de novo
subjects), with particular focus on:

For De Novo Subjects Only

- Unable to undergo pre-study washout of prohibited concomitant medications (as listed
in Section 5.2.1 of the protocol)

- Current severe or uncontrolled major depressive disorder or anxiety disorders as
assessed by the Mini-international Neuropsychiatric Interview (MINI) interview
(Version 6.0) at screening are excluded, but 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

- 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

- Subject is an employee of the study center, an immediate family member* of an employee
of the study center, or an employee of Daiichi Sankyo, INC Research, or any of the
study vendors supporting this study. *(spouse, parent, child, or sibling, whether
biological or legally adopted)

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
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NSW,QLD,SA,TAS,VIC
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Leeds
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Manchester
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Torpoint

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Daiichi Sankyo, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label study of DS-5565 in subjects who either completed participation in a
preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309 (NCT02146430),
DS5565-A-E310 (NCT02187471), or DS5565-A-E311 (NCT02187159) or are de novo subjects. Eligible
subjects will be assigned to receive open-label DS-5565 for 52 weeks. All subjects will
receive DS-5565 15 mg once daily (QD) for the first three weeks of the treatment period.
After three weeks, subjects may be titrated to 15 mg twice daily (BID) based on
protocol-specified criteria.
Trial website
https://clinicaltrials.gov/show/NCT02234583
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
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