Trial Outcomes & Findings for A Study to Assess the Analgesic Efficacy and Safety of ASP0819 in Patients With Fibromyalgia (NCT NCT03056690)

Last Updated: 2024-10-29

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

186 participants

Primary outcome timeframe

Baseline and week 8

Results posted on

2024-10-29

Participant Flow

Male and female participants between 18 and 80 years of age with fibromyalgia were enrolled in this study.

Participant milestones

Participant milestones
Measure	Placebo Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15mg Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Overall Study STARTED	95	91
Overall Study Treated	94	90
Overall Study COMPLETED	81	75
Overall Study NOT COMPLETED	14	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15mg Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Overall Study Adverse Event	3	2
Overall Study Lack of Efficacy	1	2
Overall Study Lost to Follow-up	3	2
Overall Study Protocol Violation	2	2
Overall Study Withdrawal by Subject	3	6
Overall Study Non-compliance with Study Drug	1	0
Overall Study Miscellaneous	1	2

Baseline Characteristics

The full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of study drug.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=95 Participants Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15 mg n=91 Participants Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.	Total n=186 Participants Total of all reporting groups
Age, Continuous	49.9 Years STANDARD_DEVIATION 12.5 • n=95 Participants	48.7 Years STANDARD_DEVIATION 12 • n=91 Participants	49.3 Years STANDARD_DEVIATION 12.2 • n=186 Participants
Sex: Female, Male Female	90 Participants n=95 Participants	89 Participants n=91 Participants	179 Participants n=186 Participants
Sex: Female, Male Male	5 Participants n=95 Participants	2 Participants n=91 Participants	7 Participants n=186 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=95 Participants	10 Participants n=91 Participants	23 Participants n=186 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=95 Participants	81 Participants n=91 Participants	163 Participants n=186 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=95 Participants	0 Participants n=91 Participants	0 Participants n=186 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=95 Participants	0 Participants n=91 Participants	3 Participants n=186 Participants
Race (NIH/OMB) Asian	1 Participants n=95 Participants	0 Participants n=91 Participants	1 Participants n=186 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=95 Participants	1 Participants n=91 Participants	2 Participants n=186 Participants
Race (NIH/OMB) Black or African American	16 Participants n=95 Participants	11 Participants n=91 Participants	27 Participants n=186 Participants
Race (NIH/OMB) White	74 Participants n=95 Participants	78 Participants n=91 Participants	152 Participants n=186 Participants
Race (NIH/OMB) More than one race	0 Participants n=95 Participants	0 Participants n=91 Participants	0 Participants n=186 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=95 Participants	1 Participants n=91 Participants	1 Participants n=186 Participants
Mean Daily Average Pain Score	6.32 Units on a scale STANDARD_DEVIATION 1.02 • n=94 Participants • The full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of study drug.	6.32 Units on a scale STANDARD_DEVIATION 1.01 • n=90 Participants • The full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of study drug.	6.32 Units on a scale STANDARD_DEVIATION 1.01 • n=184 Participants • The full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of study drug.

PRIMARY outcome

Timeframe: Baseline and week 8

Population: FAS population

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15 mg n=75 Participants Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Change From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS	-1.26 Units on a scale Standard Error 0.18	-1.60 Units on a scale Standard Error 0.18

PRIMARY outcome

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

Population: The safety analysis set (SAF) consisted of all randomized participants who took at least 1 dose of study drug.

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.

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15 mg n=90 Participants Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Number of Participants With Adverse Events Treatment emergent adverse event (TEAE)	53 Participants	62 Participants
Number of Participants With Adverse Events Serious TEAE	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Week 2

Population: SAF population with available data at specified time point.

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.

Outcome measures

Outcome measures
Measure	Placebo n=89 Participants Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15 mg n=90 Participants Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 2 Week 2: Suicidal Ideation	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 2 Week 2: Suicidal Behavior	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Week 4

Population: SAF population with available data at specified time point.

Outcome measures

Outcome measures
Measure	Placebo n=89 Participants Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15 mg n=90 Participants Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 4 Week 4: Suicidal Ideation	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 4 Week 4: Suicidal Behavior	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Week 8

Population: SAF population with available data at specified time point.

Outcome measures

Outcome measures
Measure	Placebo n=79 Participants Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15 mg n=74 Participants Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 8 Week 8: Suicidal Ideation	0 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 8 Week 8: Suicidal Behavior	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Week 10

Population: SAF population with available data at specified time point.

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.

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15 mg n=85 Participants Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 10 Week 10: Suicidal Ideation	1 Participants	0 Participants
Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 10 Week 10: Suicidal Behavior	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and week 8

Population: FAS population with baseline observation carried forward (BOCF) imputation.

The 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".

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15 mg n=90 Participants Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
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	29.8 Percentage of participants Interval 22.1 to 38.5	30.0 Percentage of participants Interval 22.1 to 38.9

SECONDARY outcome

Timeframe: Baseline and EOT (Up to week 8)

Population: FAS population with last observation carried forward (LOCF) imputation.

The 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.

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15 mg n=90 Participants Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Percentage of Participants Achieving ≥ 30 % Reduction From Baseline to End of Treatment (EOT) in Mean Daily Average Pain Score Assessed by NRS	30.9 Percentage of participants Interval 23.0 to 39.6	37.8 Percentage of participants Interval 29.2 to 47.0

SECONDARY outcome

Timeframe: Baseline and week 8

Population: FAS with population with BOCF imputation.

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15 mg n=90 Participants Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Percentage of Participants Achieving ≥ 50 % Reduction From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS	13.8 Percentage of participants Interval 8.4 to 21.1	15.6 Percentage of participants Interval 9.7 to 23.2

SECONDARY outcome

Timeframe: Baseline and EOT (Up to week 8)

Population: FAS population with LOCF Imputation

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15 mg n=90 Participants Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Percentage of Participants Achieving ≥ 50 % Reduction From Baseline to EOT in Mean Daily Average Pain Score Assessed by NRS	12.8 Percentage of participants Interval 7.5 to 19.9	18.9 Percentage of participants Interval 12.4 to 27.0

SECONDARY outcome

Timeframe: Baseline and weeks 2, 4, 8

Population: FAS population with available data at specified time point.

The 21-item FIQR contains 3 domains: activities of daily living, overall impact, and symptoms. Participants answer each question on an 11-point NRS, with anchors appropriate to each question. The range of function subscale scores will be 0 to 90, with a lower score indicting better (higher) function. The range of overall impact subscale scores will be 0 to 20, with a lower score indicating better (lower) impact. The range of symptoms subscale scores will be 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

Outcome measures
Measure	Placebo n=94 Participants Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15 mg n=90 Participants Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales Week 4: Overall Impact Subscale	-2.95 Units on a scale Standard Error 0.45	-4.29 Units on a scale Standard Error 0.45
Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales Week 8: Overall Impact Subscale	-3.80 Units on a scale Standard Error 0.49	-4.66 Units on a scale Standard Error 0.49
Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales Week 2: Function Subscale:	-8.48 Units on a scale Standard Error 1.47	-9.97 Units on a scale Standard Error 1.46
Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales Week 4: Function Subscale	-9.11 Units on a scale Standard Error 1.67	-12.08 Units on a scale Standard Error 1.66
Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales Week 8: Function Subscale	-11.45 Units on a scale Standard Error 1.79	-14.04 Units on a scale Standard Error 1.82
Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales Week 2: Symptom Subscale	-9.20 Units on a scale Standard Error 1.35	-10.54 Units on a scale Standard Error 1.34
Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales Week 4: Symptom Subscale	-10.05 Units on a scale Standard Error 1.51	-13.78 Units on a scale Standard Error 1.50
Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales Week 8: Symptom Subscale	-11.14 Units on a scale Standard Error 1.65	-14.20 Units on a scale Standard Error 1.68
Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales Week 2: Overall Impact Subscale	-2.94 Units on a scale Standard Error 0.45	-3.94 Units on a scale Standard Error 0.45

SECONDARY outcome

Timeframe: Baseline and EOT (Up to week 8)

Population: FAS population with LOCF Imputation.

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15 mg n=90 Participants Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales Function Subscale: EOT	-10.41 Units on a scale Standard Error 1.66	-13.55 Units on a scale Standard Error 1.70
Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales Symptom Subscale: EOT	-10.79 Units on a scale Standard Error 1.52	-14.07 Units on a scale Standard Error 1.56
Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales Overall Impact Subscale: EOT	-3.40 Units on a scale Standard Error 0.46	-4.48 Units on a scale Standard Error 0.47

SECONDARY outcome

Timeframe: Weeks 2, 4, and EOT (Up to week 8)

Population: FAS population with LOCF imputation.

The PGIC is a self-administered 7-point Likert scale that asks participants to evaluate their fibromyalgia relative to baseline. PGIC score ranges from 1 to 7, where 1 anchors "Very Much Improved" and 7 anchors "Very Much Worse".

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15 mg n=90 Participants Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 2: Very much improved	3.2 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 2: Much Improved	9.6 Percentage of participants	12.2 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 2: Minimally Improved	31.9 Percentage of participants	42.2 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 2: No Change	44.7 Percentage of participants	34.4 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 2: Minimally Worse	7.4 Percentage of participants	3.3 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 2: Much Worse	2.1 Percentage of participants	4.4 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 2: Very Much Worse	1.1 Percentage of participants	1.1 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 4: Very much improved	3.2 Percentage of participants	4.4 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 4: Much Improved	14.9 Percentage of participants	20.0 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 4: Minimally Improved	31.9 Percentage of participants	28.9 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 4: No Change	33.0 Percentage of participants	37.8 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 4: Minimally Worse	13.8 Percentage of participants	3.3 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 4: Much Worse	3.2 Percentage of participants	4.4 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 4: Very Much Worse	0 Percentage of participants	1.1 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week EOT: Very much improved	6.4 Percentage of participants	10.0 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week EOT: Much Improved	18.1 Percentage of participants	21.1 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week EOT: Minimally Improved	26.6 Percentage of participants	21.1 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week EOT: No Change	38.3 Percentage of participants	40.0 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week EOT: Minimally Worse	8.5 Percentage of participants	3.3 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week EOT: Much Worse	2.1 Percentage of participants	3.3 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week EOT: Very Much Worse	0 Percentage of participants	1.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: FAS population with modified last observation carried forward (mLOCF) imputation.

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 15 mg n=90 Participants Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 8: Much Worse	2.1 Percentage of participants	2.2 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 8: Very much improved	6.4 Percentage of participants	10.0 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 8: Much Improved	18.1 Percentage of participants	21.1 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 8: Minimally Improved	24.5 Percentage of participants	21.1 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 8: No Change	40.4 Percentage of participants	42.2 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 8: Minimally Worse	8.5 Percentage of participants	3.3 Percentage of participants
Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC) Week 8: Very Much Worse	0 Percentage of participants	0 Percentage of participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

ASP0819

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=94 participants at risk Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.	ASP0819 n=90 participants at risk A single oral dose to be taken preferably in the morning with or without food
Gastrointestinal disorders Diarrhoea	6.4% 6/94 • Number of events 6 • From first dose of study drug until end of study (up to Day 85)	2.2% 2/90 • Number of events 2 • From first dose of study drug until end of study (up to Day 85)
Gastrointestinal disorders Nausea	2.1% 2/94 • Number of events 2 • From first dose of study drug until end of study (up to Day 85)	5.6% 5/90 • Number of events 5 • From first dose of study drug until end of study (up to Day 85)
Infections and infestations Upper respiratory tract infection	4.3% 4/94 • Number of events 4 • From first dose of study drug until end of study (up to Day 85)	5.6% 5/90 • Number of events 5 • From first dose of study drug until end of study (up to Day 85)
Infections and infestations Viral upper respiratory tract infection	5.3% 5/94 • Number of events 5 • From first dose of study drug until end of study (up to Day 85)	4.4% 4/90 • Number of events 4 • From first dose of study drug until end of study (up to Day 85)
Musculoskeletal and connective tissue disorders Arthralgia	3.2% 3/94 • Number of events 3 • From first dose of study drug until end of study (up to Day 85)	5.6% 5/90 • Number of events 7 • From first dose of study drug until end of study (up to Day 85)
Musculoskeletal and connective tissue disorders Pain in extremity	3.2% 3/94 • Number of events 3 • From first dose of study drug until end of study (up to Day 85)	5.6% 5/90 • Number of events 5 • From first dose of study drug until end of study (up to Day 85)
Nervous system disorders Headache	11.7% 11/94 • Number of events 11 • From first dose of study drug until end of study (up to Day 85)	13.3% 12/90 • Number of events 20 • From first dose of study drug until end of study (up to Day 85)

Additional Information

Clinical Trial Disclosure

Astellas Pharma Global Development, Inc.

Phone: 800-888-7704

Email: [email protected]

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