A Study to Assess the Analgesic Efficacy and Safety of ASP0819 in Patients With Fibromyalgia

NCT03056690 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 0819-CL-0201
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 24

Brief Summary

This study assessed analgesic efficacy of ASP0819 relative to placebo as well as the safety and tolerability. This study assessed treatment differences in physical function as well as the improvements in overall subject status (e.g., fibromyalgia symptoms and global functioning) of ASP0819 relative to placebo.

Conditions

Fibromyalgia

Keywords

ASP0819; Fibromyalgia

Outcome Measures

Primary Outcomes (6)

• Change From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS

  The change from baseline to Week 8 in mean daily average pain score is assessed by NRS. The NRS is a generic instrument for the assessment of pain, consisting of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors "no pain" and 10 "pain as bad as you can imagine". A negative change indicates a reduction/improvement from baseline (i.e. a favorable outcome).

  Baseline and week 8

• Number of Participants With Adverse Events

  TEAE was defined as any AE which started, or worsened, after the first dose of study drug through 30 days after the last dose of study drug. AE was considered serious if: resulted in death, was life- threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization, other medically important events.

  From first dose of study drug until end of study (up to Day 85)

• Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 2

  C-SSRS was used for suicide assessment. Participants were asked detailed questions regarding suicidal ideation, behaviors, intensity of ideation, and attempts. Suicidal ideation: A "yes" answer to any one of the following five questions from suicidal ideation section on the C-SSRS. 1. Wish to be dead 2. Non-specific active suicidal thoughts 3. Active suicidal ideation with any methods (not plan) without intent to act 4. Active suicidal ideation with some intent to act, without specific plan 5. Active suicidal ideation with specific plan and intent. Suicidal behavior: "yes" answer to any one of the following five questions from suicidal behavior section on the C-SSRS. 6. Preparatory acts or behavior 7. Aborted attempt 8. Interrupted attempt 9. Actual attempt 10. Completed suicide.

  Week 2

• Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 4

  C-SSRS was used for suicide assessment. Participants were asked detailed questions regarding suicidal ideation, behaviors, intensity of ideation, and attempts. Suicidal ideation: A "yes" answer to any one of the following five questions from suicidal ideation section on the C-SSRS. 1. Wish to be dead 2. Non-specific active suicidal thoughts 3. Active suicidal ideation with any methods (not plan) without intent to act 4. Active suicidal ideation with some intent to act, without specific plan 5. Active suicidal ideation with specific plan and intent. Suicidal behavior: "yes" answer to any one of the following five questions from suicidal behavior section on the C-SSRS. 6. Preparatory acts or behavior 7. Aborted attempt 8. Interrupted attempt 9. Actual attempt 10. Completed suicide.

  Week 4

• Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 8

  C-SSRS was used for suicide assessment. Participants were asked detailed questions regarding suicidal ideation, behaviors, intensity of ideation, and attempts. Suicidal ideation: A "yes" answer to any one of the following five questions from suicidal ideation section on the C-SSRS. 1. Wish to be dead 2. Non-specific active suicidal thoughts 3. Active suicidal ideation with any methods (not plan) without intent to act 4. Active suicidal ideation with some intent to act, without specific plan 5. Active suicidal ideation with specific plan and intent. Suicidal behavior: "yes" answer to any one of the following five questions from suicidal behavior section on the C-SSRS. 6. Preparatory acts or behavior 7. Aborted attempt 8. Interrupted attempt 9. Actual attempt 10. Completed suicide.

  Week 8

• Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 10

  C-SSRS was used for suicide assessment. Participants were asked detailed questions regarding suicidal ideation, behaviors, intensity of ideation, and attempts. Suicidal ideation: A "yes" answer to any one of the following five questions from suicidal ideation section on the C-SSRS. 1. Wish to be dead 2. Non-specific active suicidal thoughts 3. Active suicidal ideation with any methods (not plan) without intent to act 4. Active suicidal ideation with some intent to act, without specific plan 5. Active suicidal ideation with specific plan and intent Suicidal behavior: "yes" answer to any one of the following five questions from suicidal behavior section on the C-SSRS. 6. Preparatory acts or behavior 7. Aborted attempt 8. Interrupted attempt 9. Actual attempt 10. Completed suicide.

  Week 10

Secondary Outcomes (8)

• Percentage of Participants Achieving Greater Than or Equal to (≥)30 % Reduction From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS

  Baseline and week 8

• Percentage of Participants Achieving ≥ 30 % Reduction From Baseline to End of Treatment (EOT) in Mean Daily Average Pain Score Assessed by NRS

  Baseline and EOT (Up to week 8)

• Percentage of Participants Achieving ≥ 50 % Reduction From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS

  Baseline and week 8

• Percentage of Participants Achieving ≥ 50 % Reduction From Baseline to EOT in Mean Daily Average Pain Score Assessed by NRS

  Baseline and EOT (Up to week 8)

• Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales

  Baseline and weeks 2, 4, 8

Study Arms (2)

ASP0819

EXPERIMENTAL

Participants received ASP019 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.

Drug: ASP0819

Placebo

PLACEBO COMPARATOR

Participants received ASP019 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.

Drug: Placebo

Interventions

ASP0819 DRUG

Oral capsule

ASP0819

Placebo DRUG

Oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a body mass index (BMI) ≤ 45 kg/m2.
• Female subject must either:
• Be of nonchildbearing potential: postmenopausal (defined as at least 1 year without any menses) prior to Screening, or documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
• Or, if of childbearing potential: agree not to try to become pregnant during the study and for 28 days after the final study drug administration, have a negative blood pregnancy test at Screening and negative urine test on Day 1, and if heterosexually active, agree to consistently use 1 form of highly effective birth control starting at Screening and throughout the study period and for 28 days after the final study drug administration.
• Female subject must agree not to breastfeed at Screening and throughout the study period, and for 28 days after the final study drug administration.
• Female subject must not donate ova starting at Screening, throughout the study period, and for 28 days after the final study drug administration
• Male subject must not donate sperm starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
• Male subject with a partner of child-bearing potential, or a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom throughout the study period and for 28 days after the final study drug administration.
• Subject meets the American College of Rheumatology (ACR) 1990 fibromyalgia diagnostic criteria at Screening:
• Widespread pain for at least 3 months, defined as the presence of all of the following: pain on right and left sides of the body, pain above and below the waist, and pain in the axial skeleton (cervical spine or anterior chest or thoracic spine or low back) must be present.
• Pain in at least 11 of 18 tender point sites on digital palpation. Digital palpation should be performed with an approximate force of 4 kg.
• Subject meets the ACR 2010 fibromyalgia diagnostic criteria at Screening:
• Widespread pain index (WPI) ≥ 7 and Symptom severity (SS) scale score ≥ 5 or WPI 3-6 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.

You may not qualify if:

• Subject has received an investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to Screening.
• Subject has had no meaningful improvement, from 2 or more prior treatments (commercially available) for fibromyalgia (in at least 2 pharmacologic classes).
• Subject has had known hypersensitivity or intolerance to the use of acetaminophen or associated formulation components; known hypersensitivity to the formulation components of ASP0819.
• Subject has pain due to diabetic peripheral neuropathy, post-herpetic neuralgia, traumatic injury, prior surgery, complex regional pain syndrome, or other source of pain that would confound or interfere with the assessment of the subject's fibromyalgia pain or require excluded therapies during the subject's study participation.
• Subject has infectious or inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and gout), autoimmune disease (e.g., systemic lupus erythematosus), or other widespread rheumatic disease other than fibromyalgia.
• Subject has a current, untreated moderate or severe major depressive disorder as assessed by the Mini-International Neuropsychiatric Interview (M.I.N.I.). Subject with current, treated major depressive disorder can be included provided that it is without clinically significant changes in symptoms while on the same dose of a protocol allowed antidepressant for greater than 60 days prior to Screening.
• Subject has initiated any non-pharmacologic interventions for the treatment of fibromyalgia or depression within 30 days prior to Screening or during the Screening period.
• Subject has a history of any psychotic and/or bipolar disorder as assessed by the M.I.N.I.
• Subject has a Hospital Anxiety and Depression Scale (HADS) score \> 14 on the Depression subscale at Screening or at the time of Visit 3 (Randomization).
• Subject has a history of suicide attempt or suicidal behavior within the last 12 months, or has suicidal ideation within the last 12 months (a response of "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS)), or who is at significant risk to commit suicide at the time of Visit 3 (Randomization).
• Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis, or a serum creatinine \> 1.5 times the Upper limit of normal (ULN) at Screening. These assessments may be repeated once, after a reasonable time period (but within the Screening period).
• Subject has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 1.5 times the upper limit of the reference range at Screening. These assessments may be repeated once, after a reasonable time period (but within the Screening period).
• Subject has a positive test for hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (immunoglobulin M) (anti-HAV \[IgM\]) or hepatitis C virus antibodies (anti-HCV) at Screening or has history of a positive test for human immunodeficiency virus type 1(HIV-1) and/or type 2 (HIV-2).
• Subject has a resting systolic blood pressure (SBP) \> 180 mmHg or \< 90 mmHg, and/or a sitting diastolic blood pressure (DBP) \> 100 mmHg at Screening. These assessments may be repeated once, after a reasonable time period (but within the Screening period).
• Subject has a clinically significant abnormality on 12-lead Electrocardiogram (ECG) at Screening or Visit 3 (Randomization). If the ECG is abnormal, an additional ECG can be carried out. If this also gives an abnormal result, the subject must be excluded.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (24)

Site US10025 - Achieve Clinical Research, LLC

Birmingham, Alabama, 35216, United States

Location

Site US10045 - TriWest Research Associates

El Cajon, California, 92020, United States

Location

Site US10039 - Superior Research LLC

Sacramento, California, 95831, United States

Location

Site US10003 - Artemis Inst For Clin Research

San Diego, California, 92103, United States

Location

Site US10048 - Diablo Clinical Research Inc

Walnut Creek, California, 94598, United States

Location

Site US10028 - Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Site US10024 - Compass Research LLC

Orlando, Florida, 32806, United States

Location

Site US10012 - Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Site US10056 - Atlanta Ctr for Med Research

Atlanta, Georgia, 30331, United States

Location

Site US10006 - Columbus Regional Research Ins

Columbus, Georgia, 31904, United States

Location

Site US10038 - Heartland Research Associates

Wichita, Kansas, 67205, United States

Location

Site US10055 - Central Kentucky Research Asc

Lexington, Kentucky, 40509, United States

Location

Site US10027 - BTC of New Bedford LLC

New Bedford, Massachusetts, 02740, United States

Location

Site US10018 - Altea Research Institute

Las Vegas, Nevada, 89102, United States

Location

Site US10010 - Upstate Clinical Research Asc

Williamsville, New York, 14221, United States

Location

Site US10032 - Peters Medical Research

High Point, North Carolina, 27262, United States

Location

Site US10031 - Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Site US10019 - Lillestol Research LLC

Fargo, North Dakota, 58103, United States

Location

Site US10037 - Dept of Psychiatry and Neuro University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Site US10059 - Hillcrest Clinical

Oklahoma City, Oklahoma, 73119, United States

Location

Site US10043 - Oregon Ctr for Clinical Invest

Portland, Oregon, 97214, United States

Location

Site US10023 - Oregon Ctr for Clinical Invest

Salem, Oregon, 97301, United States

Location

Site US10013 - Bateman Horne Center

Salt Lake City, Utah, 84102, United States

Location

Site US10005 - Charlottesville Med Research

Charlottesville, Virginia, 22911, United States

Location

Related Publications (1)

• Arnold LM, Blauwet MB, Tracy K, Cai N, Walzer M, Blahunka P, Marek GJ. Efficacy and Safety of ASP0819 in Patients with Fibromyalgia: Results of a Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial. J Pain Res. 2020 Dec 10;13:3355-3369. doi: 10.2147/JPR.S274562. eCollection 2020.

  PMID: 33328761 DERIVED

Related Links

• Link to results on the Astellas Clinical Study Results website.

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Clinical Trial Disclosure
• Organization: Astellas Pharma Global Development, Inc.

astellas.resultsdisclosure@astellas.com

800-888-7704

Study Officials

• Senior Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 17, 2017
• Study Start: March 20, 2017
• Primary Completion: February 27, 2018
• Study Completion: February 27, 2018
• Last Updated: October 29, 2024
• Results First Posted: March 3, 2021

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Locations

US (24)