Trial record 53 of 107 for:    fibromyalgia | Open Studies | Interventional Studies

An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fribromyalgia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by Daiichi Sankyo Inc.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT02234583
First received: September 4, 2014
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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, DS5565-A-E310, or DS5565-A-E311 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.


Condition Intervention Phase
Pain Associated With Fibromyalgia
Drug: 15mg DS-5565
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Number of subjects experiencing adverse events as a measure of safety [ Time Frame: Day 0 to week 52. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Subjects with abnormal values will be identified in hematology, serum chemistry, and urinalysis parameters.


Secondary Outcome Measures:
  • Changes from baseline to scheduled timepoint in Average Daily Pain Score (ADPS). [ Time Frame: week 0 (baseline) to week 52 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 1000
Study Start Date: December 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DS-5565 once daily
15mg DS-5565 administered once daily at bedtime
Drug: 15mg DS-5565
Other Name: 15mg DS-5565
Experimental: DS-5565 twice daily
15mg DS-5565 administered twice daily
Drug: 15mg DS-5565
Other Name: 15mg DS-5565

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02234583

Contacts
Contact: INC Research SM_DS5565_FM_Info@incresearch.com

Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT02234583     History of Changes
Other Study ID Numbers: DS5565-A-E312
Study First Received: September 4, 2014
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: National Health and Medical Research Council
Belarus: Ministry of Health
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: Ministry of Health
Bulgaria: Ministry of Health
Canada: Health Canada
Chile: Ministry of Health
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Croatia: Agency for Medicinal Product and Medical Devices
Czech Republic: Ministry of Health
Denmark: The Ministry of the Interior and Health
Estonia: The State Agency of Medicine
Finland: Finnish National Agency for Medicines
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Georgia: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Ministry of Health, Social and Family Affairs
India: Indian Council of Medical Research
Ireland: Ministry of Health
Israel: The Israel National Institute for Health Policy Research and Health Services Research
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
New Zealand: Ministry of Health
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Romania: National Agency for Medicines and Medical Devices
Russia: Ministry of Health of the Russian Federation
Serbia: Medicines and Medical Devices Agency
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
South Africa: Department of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Drug and Medical Device Institution
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Daiichi Sankyo Inc.:
pain
fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014