A Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia

NCT03092726 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 8062-CL-0101
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 24

Brief Summary

The purpose of this study was to assess analgesic efficacy of ASP8062 relative to placebo as well as the safety and tolerability. This study also assessed the treatment differences in physical function as well the improvements in overall subject status (e.g., fibromyalgia symptoms, global functioning) of ASP8062 relative to placebo.

Conditions

Fibromyalgia

Keywords

ASP8062; Fibromyalgia

Outcome Measures

Primary Outcomes (4)

• Change From Baseline to Week 8 in Mean Daily Average Pain Score as Assessed by Numerical Rating Scale (NRS)

  The mean daily average pain score was assessed thorugh the Daily Average Pain NRS, which is a generic instrument for the assessment of pain that consists 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." The mean daily average pain score was calculated from data recorded by participants daily in the electronic diary, and the recall period was the last 24 hours. A negative change indicated a reduction/improvement from baseline (i.e., a favorable outcome).

  Baseline and week 8

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A TEAE was defined as any AE that started or worsened after the first dose of study drug up to 30 days after the last dose of study drug. AEs were considered serious (SAEs) if the AE 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 or required inpatient hospitalization or led to prolongation of hospitalization. TEAEs in drug abuse, dependence and withdrawal standardized MedDRA query (SMQ) are special AEs of interest grouped together using the SMQ tool (MedDRA v20.0).

  From first dose of study drug up to 30 days after last dose of study drug (up to 87 days)

• Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation

  The Columbia Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide risk assessment. Affirmative or negative responses were provided to 5 items to suicidal ideation (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).

  Weeks 1 to 8

• Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behavior

  The C-SSRS is a questionnaire used for suicide risk assessment. Affirmative or negative responses were provided to 5 items to suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide).

  Weeks 1 to 8

Secondary Outcomes (6)

• Percentage of Participants With ≥ 30% Reduction From Baseline to Week 8 and End of Treatment (EOT) in Mean Daily Average Pain Score as Assessed by NRS

  Baseline to week 8

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

  Baseline to week 8

• Change From Baseline to Weeks 2, 4, 8 and EOT in the Fibromyalgia Impact Questionnaire Revised (FIQR) Function Subscale Score

  Baseline and weeks 2, 4, 8

• Change From Baseline to Weeks 2, 4, 8, and EOT in the FIQR Symptoms Subscale Score

  Baseline and weeks 2, 4, 8

• Change From Baseline to Weeks 2, 4, 8, and EOT in the FIQR Overall Impact Subscale Score

  Baseline and weeks 2, 4, 8

Study Arms (2)

ASP8062

EXPERIMENTAL

Participants received 30 mg of ASP8062 orally once daily for 8 weeks.

Drug: ASP8062

Placebo

PLACEBO COMPARATOR

Participants received matching placebo orally once daily for 8 weeks.

Drug: Placebo

Interventions

ASP8062 DRUG

ASP8062 30 mg was administered orally as a single daily dose, taken preferably in the morning with or without food.

ASP8062

Placebo DRUG

Placebo was administered orally as a single daily dose, taken preferably in the morning with or without food.

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/m\^2.
• 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 90 days after the final study drug administration.
• A sexually active male subject with female partner(s) who are of childbearing potential is eligible if:
• Agree to use a male condom starting at screening and continue throughout study treatment and for 90 days after the final study drug administration. If the male subject has not had a vasectomy or is not sterile the male subjects female partner(s) is utilizing 1 form of highly effective birth control starting at screening and continue throughout study treatment, and for 90 days after the male subject receives 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 90 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 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.

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 ASP8062.
• 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 (for example, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, gout), autoimmune disease (for example, 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 Screening and at the time of Visit 3 (Randomization).
• Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis, or a serum creatinine \> 1.5 x the 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 \> 180 mmHg or \< 90 mmHg, and/or a sitting diastolic blood pressure \> 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)

Noesis Pharma, LLC

Phoenix, Arizona, 85032, United States

Location

Excell Research, Inc

Oceanside, California, 92056, United States

Location

Collaborative Neuroscience Network, LLC.

Torrance, California, 90502, United States

Location

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Clinical Neuroscience Solutions, Inc

Orlando, Florida, 32801, United States

Location

Chicago Research Center, Inc

Chicago, Illinois, 60634, United States

Location

Medisphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Infinity Medical Research, Inc

North Dartmouth, Massachusetts, 02747, United States

Location

Elite Clinical Research, LLC

Jackson, Mississippi, 39202, United States

Location

The Center For Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Advanced Biomedical Research of America

Las Vegas, Nevada, 89123, United States

Location

NY Scientific

Brooklyn, New York, 11235, United States

Location

Neurobehavioral Research, Inc

Cedarhurst, New York, 11516, United States

Location

Private Practice

Raleigh, North Carolina, 27609, United States

Location

PMG of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Neuro-Behavioral Clinical Research, Inc

Canton, Ohio, 44718, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Meridian Clinical Research

Dakota Dunes, South Dakota, 57049, United States

Location

ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Clinical Investigation Specialists, Inc

Kenosha, Wisconsin, 53142, United States

Location

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Fibromyalgia

Interventions

ASP8062

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

• Executive 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: March 10, 2017
• First Posted: March 28, 2017
• Study Start: May 8, 2017
• Primary Completion: March 6, 2018
• Study Completion: March 6, 2018
• Last Updated: November 3, 2025
• Results First Posted: March 28, 2019

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)