Clinical trial NCT02234583: An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia
Official title: An Open-label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain Associated With Fibromyalgia
Keywords: pain
fibromyalgia
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2014-09-09
Enrollment: 2485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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 α2δ 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)

Primary outcomes:
measure: Average Daily Pain Score (ADPS) for DS-5565
timeFrame: Day 0 (baseline) up to to Week 52 postdose
Secondary outcomes:
measure: 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
timeFrame: Week 52 postdose
measure: Hospital Anxiety Depression Scale (HADS) Depression and Anxiety Scores for DS-5565
timeFrame: Day 0 (baseline) up to Week 52 postdose
measure: EuroQol Five Dimensions Questionnaire (EQ-5D) Measure for DS-5565
timeFrame: Day 0 (baseline) up to Week 52 postdose
measure: Short Form-36 (SF-36) Measure for DS-5565
timeFrame: Day 0 (baseline) to Week 52 postdose
measure: Pain-Associated Sleep Interference as Assessed by Average Daily Sleep Interference Score (ADSIS) for DS-5565
timeFrame: Day 0 (baseline) up to Week 52 postdose
Other outcomes:
Locations:
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city: Fresno
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city: Los Alamitos
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city: North Massapequa
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country: Poland
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country: Poland
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country: Portugal
city: Guimaraes
country: Portugal
city: Porto
country: Portugal
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country: Portugal
city: Ponce
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: Bacau
country: Romania
city: Bucharest
country: Romania
city: Targu Mures
country: Romania
city: Krasnoyarsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhniy Novgarad
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Belgrade
country: Serbia
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Dubnica nad Vahom
country: Slovakia
city: Galanta
country: Slovakia
city: Krompachy
country: Slovakia
city: Piešťany
country: Slovakia
city: Presov
country: Slovakia
city: Ljubljana
country: Slovenia
city: Slovenj Gradec
country: Slovenia
city: Bayview
country: South Africa
state: Chatsworth
city: Johannesburg
country: South Africa
state: Gautang
city: Pretoria
country: South Africa
state: Gautang
city: Durban
country: South Africa
state: Kwazulu Natal
city: Cape Town
country: South Africa
state: Western Cape
city: Somerset West
country: South Africa
state: Western Cape
city: Stellenbosch
country: South Africa
city: Santiago de Compostela
country: Spain
state: A Coruna
city: Barcelona
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Dnipropetrovsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kherson
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Zaporizhzhia
country: Ukraine
city: Penzance
country: United Kingdom
state: Cornwall
city: Chesterfield
country: United Kingdom
state: Derbyshire
city: Romford
country: United Kingdom
state: Essex
city: Manchester
country: United Kingdom
state: Greater Manchester
city: Blackpool
country: United Kingdom
state: Lancashire
city: Thornton-Cleveleys
country: United Kingdom
state: Lancashire
city: Wigan
country: United Kingdom
state: Lancashire
city: Stourton
country: United Kingdom
state: Leeds
city: Salford
country: United Kingdom
state: Manchester
city: Southport
country: United Kingdom
state: Merseyside
city: Wellingborough
country: United Kingdom
state: Northamptonshire
city: Belfast
country: United Kingdom
state: Northern Ireland
city: Cannock
country: United Kingdom
state: Staffordshire
city: North Shields
country: United Kingdom
state: Tyne And Wear
city: Atherstone
country: United Kingdom
state: Warwickshire
city: Torpoint
country: United Kingdom
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
citation: 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.