Trial Outcomes & Findings for A Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia (NCT NCT03092726)
NCT ID: NCT03092726
Last Updated: 2025-11-03
Results Overview
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).
COMPLETED
PHASE2
183 participants
Baseline and week 8
2025-11-03
Participant Flow
Participants with fibromyalgia (FM) were enrolled in 24 sites in the United States.
Participants underwent a screening period (up to 42 days), where washout of medications and a 7-day baseline diary run-in were completed. Participants were randomized (1:1 ratio) after confirmation of eligibility (which also required a mean daily average pain score of ≥ 4 and ≤ 9 \[per Daily Average Pain Numerical Rating Scale\] to enter the study).
Participant milestones
| Measure |
Placebo
Participants received matching placebo orally once daily for 8 weeks.
|
ASP8062
Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
95
|
|
Overall Study
Treated
|
88
|
95
|
|
Overall Study
COMPLETED
|
79
|
81
|
|
Overall Study
NOT COMPLETED
|
9
|
14
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo orally once daily for 8 weeks.
|
ASP8062
Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Adverse Event
|
3
|
10
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
The analysis population was the FAS.
Baseline characteristics by cohort
| Measure |
Placebo
n=88 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
ASP8062
n=95 Participants
Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity
Hispanic or Latino
|
17 Participants
n=3 Participants
|
18 Participants
n=15 Participants
|
35 Participants
n=18 Participants
|
|
Age, Continuous
Age
|
51.3 Years
STANDARD_DEVIATION 12.9 • n=3 Participants
|
52.5 Years
STANDARD_DEVIATION 11.9 • n=15 Participants
|
51.9 Years
STANDARD_DEVIATION 12.3 • n=18 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=3 Participants
|
93 Participants
n=15 Participants
|
176 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=3 Participants
|
2 Participants
n=15 Participants
|
7 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
69 Participants
n=3 Participants
|
70 Participants
n=15 Participants
|
139 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
15 Participants
n=3 Participants
|
20 Participants
n=15 Participants
|
35 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=3 Participants
|
1 Participants
n=15 Participants
|
4 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
3 Participants
n=15 Participants
|
3 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=3 Participants
|
1 Participants
n=15 Participants
|
2 Participants
n=18 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
71 Participants
n=3 Participants
|
77 Participants
n=15 Participants
|
148 Participants
n=18 Participants
|
|
Baseline Mean Daily Average Pain Score Group
Severe: >= 7 to 10
|
29 Participants
n=3 Participants • The analysis population was the FAS.
|
38 Participants
n=15 Participants • The analysis population was the FAS.
|
67 Participants
n=18 Participants • The analysis population was the FAS.
|
|
Baseline Mean Daily Average Pain Score Group
No pain: 0
|
0 Participants
n=3 Participants • The analysis population was the FAS.
|
0 Participants
n=15 Participants • The analysis population was the FAS.
|
0 Participants
n=18 Participants • The analysis population was the FAS.
|
|
Baseline Mean Daily Average Pain Score Group
Mild: > 0 to < 4
|
0 Participants
n=3 Participants • The analysis population was the FAS.
|
0 Participants
n=15 Participants • The analysis population was the FAS.
|
0 Participants
n=18 Participants • The analysis population was the FAS.
|
|
Baseline Mean Daily Average Pain Score Group
Moderate: >= 4 to < 7
|
59 Participants
n=3 Participants • The analysis population was the FAS.
|
57 Participants
n=15 Participants • The analysis population was the FAS.
|
116 Participants
n=18 Participants • The analysis population was the FAS.
|
|
Baseline Mean Daily Average Pain Score
|
6.49 units on a scale
STANDARD_DEVIATION 1.03 • n=3 Participants • The analysis population was the full analysis set (FAS), which consisted of all randomized participants who took at least 1 dose of study drug.
|
6.54 units on a scale
STANDARD_DEVIATION 0.97 • n=15 Participants • The analysis population was the full analysis set (FAS), which consisted of all randomized participants who took at least 1 dose of study drug.
|
6.51 units on a scale
STANDARD_DEVIATION 1 • n=18 Participants • The analysis population was the full analysis set (FAS), which consisted of all randomized participants who took at least 1 dose of study drug.
|
PRIMARY outcome
Timeframe: Baseline and week 8Population: The analysis population was the full analysis set (FAS), which consisted of all randomized participants who took at least 1 dose of study drug. Participants with available data at baseline were included in the analysis.
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).
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
ASP8062
n=95 Participants
Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline to Week 8 in Mean Daily Average Pain Score as Assessed by Numerical Rating Scale (NRS)
|
-1.42 Units on a scale
Standard Error 0.19
|
-1.36 Units on a scale
Standard Error 0.19
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 30 days after last dose of study drug (up to 87 days)Population: The analysis population was the SAF.
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).
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
ASP8062
n=95 Participants
Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAE in drug abuse and dependence SMQ
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Drug abuse-related TEAEs
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE
|
43 Participants
|
67 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Drug-related TEAE
|
19 Participants
|
45 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Serious TEAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Drug-related serious TEAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAE leading to withdrawal of treatment
|
3 Participants
|
10 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Death
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAE in drug abuse, dependence, withdrawal SMQ
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAE in drug withdrawal SMQ
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Drug withdrawal-related TEAEs
|
18 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Weeks 1 to 8Population: The analysis population was the SAF. Participants with available data were included in the analysis.
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).
Outcome measures
| Measure |
Placebo
n=86 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
ASP8062
n=90 Participants
Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
|
|---|---|---|
|
Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation
Wish to be dead
|
1 Participants
|
1 Participants
|
|
Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation
Non-specific active suicidal thoughts
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation
With any methods (not plan) w/o intent to act
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation
With some intent to act, w/o specific plan
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation
With specific plan and intent
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Weeks 1 to 8Population: The analysis population was the SAF. Participants with available data were included in the analysis.
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).
Outcome measures
| Measure |
Placebo
n=86 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
ASP8062
n=90 Participants
Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
|
|---|---|---|
|
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behavior
Preparatory acts or behavior
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behavior
Aborted attempt
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behavior
Interrupted attempt
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behavior
Actual attempt
|
0 Participants
|
0 Participants
|
|
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behavior
Completed suicide
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 8Population: The analysis population was the FAS. Baseline Observation Carried Forward (BOCF) was used for week 8. Last Observation Carried Forward (LOCF) was used for EOT.
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 analysis, participants with missing baseline or EOT data were classified as nonresponders.
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
ASP8062
n=95 Participants
Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
|
|---|---|---|
|
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
Week 8
|
31.8 Percentage of participants
Interval 23.6 to 40.9
|
25.3 Percentage of participants
Interval 18.1 to 33.7
|
|
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
EOT
|
33.0 Percentage of participants
Interval 24.7 to 42.1
|
27.4 Percentage of participants
Interval 19.9 to 35.9
|
SECONDARY outcome
Timeframe: Baseline to week 8Population: The analysis population was the FAS. BOCF was used for week 8. LOCF was used for EOT.
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 analysis, participants with missing baseline or EOT data were classified as nonresponders.
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
ASP8062
n=95 Participants
Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
|
|---|---|---|
|
Percentage of Participants With ≥ 50% Reduction From Baseline to Week 8 and EOT in Mean Daily Average Pain Score as Assessed by NRS
Week 8
|
12.5 Percentage of participants
Interval 7.2 to 19.8
|
14.7 Percentage of participants
Interval 9.1 to 22.1
|
|
Percentage of Participants With ≥ 50% Reduction From Baseline to Week 8 and EOT in Mean Daily Average Pain Score as Assessed by NRS
EOT
|
12.5 Percentage of participants
Interval 7.2 to 19.8
|
16.8 Percentage of participants
Interval 10.9 to 24.4
|
SECONDARY outcome
Timeframe: Baseline and weeks 2, 4, 8Population: The analysis population was the FAS. Participants with available data at baseline were included in the analysis. LOCF was used for EOT.
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. A negative change indicated a reduction/improvement from baseline (i.e., a favorable outcome).
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
ASP8062
n=95 Participants
Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline to Weeks 2, 4, 8 and EOT in the Fibromyalgia Impact Questionnaire Revised (FIQR) Function Subscale Score
Week 2
|
-8.21 Units on a scale
Standard Error 1.46
|
-8.89 Units on a scale
Standard Error 1.42
|
|
Change From Baseline to Weeks 2, 4, 8 and EOT in the Fibromyalgia Impact Questionnaire Revised (FIQR) Function Subscale Score
Week 4
|
-10.25 Units on a scale
Standard Error 1.67
|
-10.89 Units on a scale
Standard Error 1.65
|
|
Change From Baseline to Weeks 2, 4, 8 and EOT in the Fibromyalgia Impact Questionnaire Revised (FIQR) Function Subscale Score
Week 8
|
-12.88 Units on a scale
Standard Error 1.91
|
-12.02 Units on a scale
Standard Error 1.89
|
|
Change From Baseline to Weeks 2, 4, 8 and EOT in the Fibromyalgia Impact Questionnaire Revised (FIQR) Function Subscale Score
EOT
|
-12.05 Units on a scale
Standard Error 1.87
|
-10.96 Units on a scale
Standard Error 1.78
|
SECONDARY outcome
Timeframe: Baseline and weeks 2, 4, 8Population: The analysis population was the FAS. Participants with available data at baseline were included in the analysis. LOCF was used for EOT.
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., a favorable outcome).
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
ASP8062
n=95 Participants
Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline to Weeks 2, 4, 8, and EOT in the FIQR Symptoms Subscale Score
Week 8
|
-12.40 Units on a scale
Standard Error 1.83
|
-10.70 Units on a scale
Standard Error 1.82
|
|
Change From Baseline to Weeks 2, 4, 8, and EOT in the FIQR Symptoms Subscale Score
Week 2
|
-9.05 Units on a scale
Standard Error 1.33
|
-8.89 Units on a scale
Standard Error 1.29
|
|
Change From Baseline to Weeks 2, 4, 8, and EOT in the FIQR Symptoms Subscale Score
Week 4
|
-10.91 Units on a scale
Standard Error 1.49
|
-9.45 Units on a scale
Standard Error 1.46
|
|
Change From Baseline to Weeks 2, 4, 8, and EOT in the FIQR Symptoms Subscale Score
EOT
|
-11.47 Units on a scale
Standard Error 1.77
|
-9.79 Units on a scale
Standard Error 1.69
|
SECONDARY outcome
Timeframe: Baseline and weeks 2, 4, 8Population: The analysis population was the FAS. Participants with available data at baseline were included in the analysis. LOCF was used for EOT.
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., a favorable outcome).
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
ASP8062
n=95 Participants
Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
|
|---|---|---|
|
Change From Baseline to Weeks 2, 4, 8, and EOT in the FIQR Overall Impact Subscale Score
Week 4
|
-3.04 Units on a scale
Standard Error 0.52
|
-3.20 Units on a scale
Standard Error 0.51
|
|
Change From Baseline to Weeks 2, 4, 8, and EOT in the FIQR Overall Impact Subscale Score
EOT
|
-3.38 Units on a scale
Standard Error 0.49
|
-3.21 Units on a scale
Standard Error 0.46
|
|
Change From Baseline to Weeks 2, 4, 8, and EOT in the FIQR Overall Impact Subscale Score
Week 8
|
-3.50 Units on a scale
Standard Error 0.50
|
-3.44 Units on a scale
Standard Error 0.50
|
|
Change From Baseline to Weeks 2, 4, 8, and EOT in the FIQR Overall Impact Subscale Score
Week 2
|
-2.79 Units on a scale
Standard Error 0.42
|
-2.60 Units on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8Population: The analysis population was the FAS. Modified LOCF (mLOCF) was used for weeks 2, 4, and 8, where "No Change" was imputed for participants who discontinued due to lack of efficacy or AEs, and LOCF was used for participants who discontinued due to other reasons. LOCF was used for EOT.
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").
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants received matching placebo orally once daily for 8 weeks.
|
ASP8062
n=95 Participants
Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
|
|---|---|---|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 4 · No Change
|
28 Participants
|
39 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 4 · Minimally Worse
|
8 Participants
|
6 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 4 · Very Much Improved
|
2 Participants
|
6 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 4 · Much Improved
|
13 Participants
|
13 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 4 · Minimally Improved
|
34 Participants
|
23 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 4 · Much Worse
|
3 Participants
|
8 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 4 · Very Much Worse
|
0 Participants
|
0 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 8 · Very Much Improved
|
5 Participants
|
12 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 8 · Much Improved
|
13 Participants
|
12 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 8 · Minimally Improved
|
33 Participants
|
17 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 8 · No Change
|
26 Participants
|
38 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 8 · Minimally Worse
|
6 Participants
|
10 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 8 · Much Worse
|
4 Participants
|
6 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 8 · Very Much Worse
|
1 Participants
|
0 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
EOT · Very Much Improved
|
5 Participants
|
12 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
EOT · Much Improved
|
13 Participants
|
12 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
EOT · Minimally Improved
|
34 Participants
|
19 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
EOT · No Change
|
24 Participants
|
34 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
EOT · Minimally Worse
|
6 Participants
|
11 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
EOT · Much Worse
|
4 Participants
|
7 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
EOT · Very Much Worse
|
2 Participants
|
0 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 2 · Very Much Improved
|
0 Participants
|
4 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 2 · Much Improved
|
7 Participants
|
9 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 2 · Minimally Improved
|
34 Participants
|
28 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 2 · No Change
|
34 Participants
|
42 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 2 · Minimally Worse
|
7 Participants
|
9 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 2 · Much Worse
|
5 Participants
|
3 Participants
|
|
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Week 2 · Very Much Worse
|
1 Participants
|
0 Participants
|
Adverse Events
Placebo
ASP8062 30 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=88 participants at risk
Participants received matching placebo orally once daily for 8 weeks.
|
ASP8062 30 mg
n=95 participants at risk
Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.5%
4/88 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (up to 87 days)
|
6.3%
6/95 • Number of events 6 • From first dose of study drug up to 30 days after last dose of study drug (up to 87 days)
|
|
Infections and infestations
Urinary tract infection
|
5.7%
5/88 • Number of events 5 • From first dose of study drug up to 30 days after last dose of study drug (up to 87 days)
|
3.2%
3/95 • Number of events 3 • From first dose of study drug up to 30 days after last dose of study drug (up to 87 days)
|
|
Nervous system disorders
Dizziness
|
2.3%
2/88 • Number of events 2 • From first dose of study drug up to 30 days after last dose of study drug (up to 87 days)
|
29.5%
28/95 • Number of events 33 • From first dose of study drug up to 30 days after last dose of study drug (up to 87 days)
|
|
Nervous system disorders
Headache
|
11.4%
10/88 • Number of events 11 • From first dose of study drug up to 30 days after last dose of study drug (up to 87 days)
|
14.7%
14/95 • Number of events 17 • From first dose of study drug up to 30 days after last dose of study drug (up to 87 days)
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma Global Development, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER