NCT03092726

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

Completed Phase 2 Results posted Last updated 3 November 2025

What this trial tests

Phase 2 trial testing ASP8062 in Fibromyalgia in 183 participants. Completed in 6 March 2018.

Timeline

8 May 2017

Primary endpoint
6 March 2018

6 March 2018

Quick facts

Lead sponsor	Astellas Pharma Global Development, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	183
Start date	8 May 2017
Primary completion	6 March 2018
Estimated completion	6 March 2018
Sites	24 locations across United States

Drugs / interventions tested

• ASP8062 — full drug profile →
• Placebo

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

Astellas Pharma Global Development, Inc. — full company profile →

Who can join

Adults 18 to 80, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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).

Group	Value	95% CI
Placebo	-1.42	± 0.19
ASP8062	-1.36	± 0.19

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Primary · From first dose of study drug up to 30 days after last dose of study drug (up to 87 days)

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 disabilit

Any TEAE

Group	Value	95% CI
Placebo	43
ASP8062	67

Drug-related TEAE

Group	Value	95% CI
Placebo	19
ASP8062	45

Serious TEAE

Group	Value	95% CI
Placebo	0
ASP8062	0

Drug-related serious TEAE

Group	Value	95% CI
Placebo	0
ASP8062	0

TEAE leading to withdrawal of treatment

Group	Value	95% CI
Placebo	3
ASP8062	10

Death

Group	Value	95% CI
Placebo	0
ASP8062	0

TEAE in drug abuse, dependence, withdrawal SMQ

Group	Value	95% CI
Placebo	0
ASP8062	0

TEAE in drug abuse and dependence SMQ

Group	Value	95% CI
Placebo	0
ASP8062	0

Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation Primary · Weeks 1 to 8

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).

Wish to be dead

Group	Value	95% CI
Placebo	1
ASP8062	1

Non-specific active suicidal thoughts

Group	Value	95% CI
Placebo	0
ASP8062	0

With any methods (not plan) w/o intent to act

Group	Value	95% CI
Placebo	0
ASP8062	0

With some intent to act, w/o specific plan

Group	Value	95% CI
Placebo	0
ASP8062	0

With specific plan and intent

Group	Value	95% CI
Placebo	0
ASP8062	0

Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behavior Primary · Weeks 1 to 8

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).

Preparatory acts or behavior

Group	Value	95% CI
Placebo	0
ASP8062	0

Aborted attempt

Group	Value	95% CI
Placebo	0
ASP8062	0

Interrupted attempt

Group	Value	95% CI
Placebo	0
ASP8062	0

Actual attempt

Group	Value	95% CI
Placebo	0
ASP8062	0

Completed suicide

Group	Value	95% CI
Placebo	0
ASP8062	0

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 Secondary · Baseline to week 8

The mean daily average pain score was assessed through 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. For the week 8 analysis, participants with missing baseline or week 8 data were classified as nonresponders. For EOT a

Week 8

Group	Value	95% CI
Placebo	31.8	23.6 – 40.9
ASP8062	25.3	18.1 – 33.7

EOT

Group	Value	95% CI
Placebo	33.0	24.7 – 42.1
ASP8062	27.4	19.9 – 35.9

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

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. For the week 8 analysis, participants with missing baseline or week 8 data were classified as nonresponders. For EOT a

Week 8

Group	Value	95% CI
Placebo	12.5	7.2 – 19.8
ASP8062	14.7	9.1 – 22.1

EOT

Group	Value	95% CI
Placebo	12.5	7.2 – 19.8
ASP8062	16.8	10.9 – 24.4

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

The FIQR was developed to capture total spectrum of problems related to fibromyalgia and the responses to therapy. The 21-item FIQR contains 3 subscales: function (9 questions), overall impact (2 questions), and symptoms (10 questions). Participants answer each question on an 11-point NRS, with anchors appropriate to each question on a tablet device during a visit. The recall period was the last 7 days or the last time the activity was performed if not within the 7-day recall period. The Function subscale has a range of scores of 0 to 90, with a lower score indicating better (higher) function.

Week 2

Group	Value	95% CI
Placebo	-8.21	± 1.46
ASP8062	-8.89	± 1.42

Week 4

Group	Value	95% CI
Placebo	-10.25	± 1.67
ASP8062	-10.89	± 1.65

Week 8

Group	Value	95% CI
Placebo	-12.88	± 1.91
ASP8062	-12.02	± 1.89

EOT

Group	Value	95% CI
Placebo	-12.05	± 1.87
ASP8062	-10.96	± 1.78

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

The FIQR was developed to capture the total spectrum of problems related to fibromyalgia and the responses to therapy. The 21-item FIQR contains 3 subscales: function (9 questions), overall impact (2 questions), and symptoms (10 questions). Participants answer each question on an 11-point NRS, with anchors appropriate to each question on a tablet device during a visit. The recall period was the last 7 days. The Symptoms subscale range of scores is 0 to 100, with a lower score indicating a better (lower) level of symptoms. A negative change indicates a reduction/improvement from baseline (i.e.,

Week 2

Group	Value	95% CI
Placebo	-9.05	± 1.33
ASP8062	-8.89	± 1.29

Week 4

Group	Value	95% CI
Placebo	-10.91	± 1.49
ASP8062	-9.45	± 1.46

Week 8

Group	Value	95% CI
Placebo	-12.40	± 1.83
ASP8062	-10.70	± 1.82

EOT

Group	Value	95% CI
Placebo	-11.47	± 1.77
ASP8062	-9.79	± 1.69

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

The FIQR was developed to capture the total spectrum of problems related to fibromyalgia and the responses to therapy. The 21-item FIQR contains 3 subscales: function (9 questions), overall impact (2 questions), and symptoms (10 questions). Participants answer each question on an 11-point NRS, with anchors appropriate to each question on a tablet device during a visit. The recall period was the last 7 days. The Overall Impact subscale has a range of scores from 0 to 20, with a lower score indicating better (lower) impact. A negative change indicated a reduction/improvement from baseline (i.e.,

Week 2

Group	Value	95% CI
Placebo	-2.79	± 0.42
ASP8062	-2.60	± 0.41

Week 4

Group	Value	95% CI
Placebo	-3.04	± 0.52
ASP8062	-3.20	± 0.51

Week 8

Group	Value	95% CI
Placebo	-3.50	± 0.50
ASP8062	-3.44	± 0.50

EOT

Group	Value	95% CI
Placebo	-3.38	± 0.49
ASP8062	-3.21	± 0.46

Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC) Secondary · Weeks 2, 4, 8

The PGIC is a self-administered 7-point Likert scale that asks participants to evaluate their fibromyalgia relative to baseline. This is a single question and the grade ranges from 1 ("Very Much Improved") to 7 ("Very Much Worse").

Week 2

Group	Value	95% CI
Placebo	0
ASP8062	4
Placebo	7
ASP8062	9
Placebo	34
ASP8062	28
Placebo	34
ASP8062	42

Week 4

Group	Value	95% CI
Placebo	2
ASP8062	6
Placebo	13
ASP8062	13
Placebo	34
ASP8062	23
Placebo	28
ASP8062	39

Week 8

Group	Value	95% CI
Placebo	5
ASP8062	12
Placebo	13
ASP8062	12
Placebo	33
ASP8062	17
Placebo	26
ASP8062	38

EOT

Group	Value	95% CI
Placebo	5
ASP8062	12
Placebo	13
ASP8062	12
Placebo	34
ASP8062	19
Placebo	24
ASP8062	34

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug up to 30 days after last dose of study drug (up to 87 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/88 (0%)

Deaths: 0/88

ASP8062 30 mg

Serious: 0/95 (0%)

Deaths: 0/95

Other adverse events (4 terms — click to expand)

Reaction	System	Placebo	ASP8062 30 mg
Dizziness	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Urinary tract infection	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT03092726 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.