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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056690
Recruitment Status : Completed
First Posted : February 17, 2017
Results First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Drug: ASP0819
Drug: Placebo
Enrollment 186
Recruitment Details Male and female participants between 18 and 80 years of age with fibromyalgia were enrolled in this study.
Pre-assignment Details  
Arm/Group Title Placebo ASP0819 15mg
Hide Arm/Group Description Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks. Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Period Title: Overall Study
Started 95 91
Treated 94 90
Completed 81 75
Not Completed 14 16
Reason Not Completed
Adverse Event             3             2
Lack of Efficacy             1             2
Lost to Follow-up             3             2
Protocol Violation             2             2
Withdrawal by Subject             3             6
Non-compliance with Study Drug             1             0
Miscellaneous             1             2
Arm/Group Title Placebo ASP0819 15 mg Total
Hide Arm/Group Description Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks. Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 95 91 186
Hide Baseline Analysis Population Description
All participants who were randomized to this study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 95 participants 91 participants 186 participants
49.9  (12.5) 48.7  (12) 49.3  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 91 participants 186 participants
Female
90
  94.7%
89
  97.8%
179
  96.2%
Male
5
   5.3%
2
   2.2%
7
   3.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 91 participants 186 participants
Hispanic or Latino
13
  13.7%
10
  11.0%
23
  12.4%
Not Hispanic or Latino
82
  86.3%
81
  89.0%
163
  87.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 91 participants 186 participants
American Indian or Alaska Native
3
   3.2%
0
   0.0%
3
   1.6%
Asian
1
   1.1%
0
   0.0%
1
   0.5%
Native Hawaiian or Other Pacific Islander
1
   1.1%
1
   1.1%
2
   1.1%
Black or African American
16
  16.8%
11
  12.1%
27
  14.5%
White
74
  77.9%
78
  85.7%
152
  81.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   1.1%
1
   0.5%
Mean Daily Average Pain Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 94 participants 90 participants 184 participants
6.32  (1.02) 6.32  (1.01) 6.32  (1.01)
[1]
Measure Description: The mean daily average pain score is assessed by numerical rating scale (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".
[2]
Measure Analysis Population Description: The full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of study drug.
1.Primary Outcome
Title Change From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS
Hide Description 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).
Time Frame Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population
Arm/Group Title Placebo ASP0819 15 mg
Hide Arm/Group Description:
Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Overall Number of Participants Analyzed 81 75
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.26  (0.18) -1.60  (0.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Mixed model repeated measures (MMRM) analysis model is performed with change from baseline (Week 8) as response; treatment, center (pooled where necessary), time (week 8) and treatment*time as fixed effects, baseline and baseline*time as covariates.
Statistical Test of Hypothesis P-Value 0.086
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -0.34
Confidence Interval (2-Sided) 90%
-0.76 to 0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description 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.
Time Frame From first dose of study drug until end of study (up to Day 85)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAF) consisted of all randomized participants who took at least 1 dose of study drug.
Arm/Group Title Placebo ASP0819 15 mg
Hide Arm/Group Description:
Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Overall Number of Participants Analyzed 94 90
Measure Type: Number
Unit of Measure: Participants
Treatment emergent adverse event (TEAE) 53 62
Serious TEAE 0 0
3.Primary Outcome
Title Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 2
Hide Description 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.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
SAF population with available data at specified time point.
Arm/Group Title Placebo ASP0819 15 mg
Hide Arm/Group Description:
Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Overall Number of Participants Analyzed 89 90
Measure Type: Number
Unit of Measure: Participants
Week 2: Suicidal Ideation 0 0
Week 2: Suicidal Behavior 0 0
4.Primary Outcome
Title Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 4
Hide Description 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.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
SAF population with available data at specified time point.
Arm/Group Title Placebo ASP0819 15 mg
Hide Arm/Group Description:
Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Overall Number of Participants Analyzed 89 90
Measure Type: Number
Unit of Measure: Participants
Week 4: Suicidal Ideation 0 0
Week 4: Suicidal Behavior 0 0
5.Primary Outcome
Title Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 8
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
SAF population with available data at specified time point.
Arm/Group Title Placebo ASP0819 15 mg
Hide Arm/Group Description:
Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Overall Number of Participants Analyzed 79 74
Measure Type: Number
Unit of Measure: Participants
Week 8: Suicidal Ideation 0 0
Week 8: Suicidal Behavior 0 0
6.Primary Outcome
Title Number of Participants With Suicidal Ideation and Suicidal Behavior at Week 10
Hide Description 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.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
SAF population with available data at specified time point.
Arm/Group Title Placebo ASP0819 15 mg
Hide Arm/Group Description:
Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Overall Number of Participants Analyzed 88 85
Measure Type: Number
Unit of Measure: Participants
Week 10: Suicidal Ideation 1 0
Week 10: Suicidal Behavior 0 0
7.Secondary Outcome
Title 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
Hide Description 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".
Time Frame Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with baseline observation carried forward (BOCF) imputation.
Arm/Group Title Placebo ASP0819 15 mg
Hide Arm/Group Description:
Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Overall Number of Participants Analyzed 94 90
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
29.8
(22.1 to 38.5)
30.0
(22.1 to 38.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.551
Comments [Not Specified]
Method Fisher Exact
Comments CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 90%
-11.9 to 12.5
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants Achieving ≥ 30 % Reduction From Baseline to End of Treatment (EOT) in Mean Daily Average Pain Score Assessed by NRS
Hide Description 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.
Time Frame Baseline and EOT (Up to week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with last observation carried forward (LOCF) imputation.
Arm/Group Title Placebo ASP0819 15 mg
Hide Arm/Group Description:
Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Overall Number of Participants Analyzed 94 90
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
30.9
(23.0 to 39.6)
37.8
(29.2 to 47.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.202
Comments [Not Specified]
Method Fisher Exact
Comments CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.
Method of Estimation Estimation Parameter Difference
Estimated Value 6.9
Confidence Interval (2-Sided) 90%
-5.2 to 19.1
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants Achieving ≥ 50 % Reduction From Baseline to Week 8 in Mean Daily Average Pain Score Assessed by NRS
Hide Description 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".
Time Frame Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS with population with BOCF imputation.
Arm/Group Title Placebo ASP0819 15 mg
Hide Arm/Group Description:
Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Overall Number of Participants Analyzed 94 90
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
13.8
(8.4 to 21.1)
15.6
(9.7 to 23.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.451
Comments [Not Specified]
Method Fisher Exact
Comments CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.
Method of Estimation Estimation Parameter Difference
Estimated Value 1.7
Confidence Interval (2-Sided) 90%
-10.5 to 13.8
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants Achieving ≥ 50 % Reduction From Baseline to EOT in Mean Daily Average Pain Score Assessed by NRS
Hide Description 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".
Time Frame Baseline and EOT (Up to week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with LOCF Imputation
Arm/Group Title Placebo ASP0819 15 mg
Hide Arm/Group Description:
Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Overall Number of Participants Analyzed 94 90
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
12.8
(7.5 to 19.9)
18.9
(12.4 to 27.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.174
Comments [Not Specified]
Method Fisher Exact
Comments CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.
Method of Estimation Estimation Parameter Difference
Estimated Value 6.1
Confidence Interval (2-Sided) 90%
-6.2 to 18.1
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales.
Hide Description 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).
Time Frame Baseline and weeks 2, 4, 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with available data at specified time point.
Arm/Group Title Placebo ASP0819 15 mg
Hide Arm/Group Description:
Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Overall Number of Participants Analyzed 94 90
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 2: Function Subscale: Number Analyzed 90 participants 90 participants
-8.48  (1.47) -9.97  (1.46)
Week 4: Function Subscale Number Analyzed 84 participants 83 participants
-9.11  (1.67) -12.08  (1.66)
Week 8: Function Subscale Number Analyzed 81 participants 73 participants
-11.45  (1.79) -14.04  (1.82)
Week 2: Symptom Subscale Number Analyzed 90 participants 90 participants
-9.20  (1.35) -10.54  (1.34)
Week 4: Symptom Subscale Number Analyzed 84 participants 83 participants
-10.05  (1.51) -13.78  (1.50)
Week 8: Symptom Subscale Number Analyzed 81 participants 73 participants
-11.14  (1.65) -14.20  (1.68)
Week 2: Overall Impact Subscale Number Analyzed 90 participants 90 participants
-2.94  (0.45) -3.94  (0.45)
Week 4: Overall Impact Subscale Number Analyzed 84 participants 83 participants
-2.95  (0.45) -4.29  (0.45)
Week 8: Overall Impact Subscale Number Analyzed 81 participants 73 participants
-3.80  (0.49) -4.66  (0.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments Function Subscale: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.235
Comments MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment*time as fixed effects, baseline and baseline*time as covariates.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean difference
Estimated Value -1.48
Confidence Interval (2-Sided) 90%
-4.86 to 1.90
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments Function Subscale: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment*time as fixed effects, baseline and baseline*time as covariates.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -2.97
Confidence Interval (2-Sided) 90%
-6.84 to 0.89
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments Function Subscale: Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.154
Comments MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment*time as fixed effects, baseline and baseline*time as covariates.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -2.59
Confidence Interval (2-Sided) 90%
-6.78 to 1.60
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments Symptoms Subscale: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.238
Comments MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment*time as fixed effects, baseline and baseline*time as covariates.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -1.34
Confidence Interval (2-Sided) 90%
-4.45 to 1.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments Symptoms Subscale: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment*time as fixed effects, baseline and baseline*time as covariates.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -3.73
Confidence Interval (2-Sided) 90%
-7.22 to -0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments Symptoms Subscale: Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.097
Comments MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment*time as fixed effects, baseline and baseline*time as covariates.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -3.06
Confidence Interval (2-Sided) 90%
-6.93 to 0.81
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments Overall Impact Subscale: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment*time as fixed effects, baseline and baseline*time as covariates.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean DIfference
Estimated Value -0.99
Confidence Interval (2-Sided) 90%
-2.03 to 0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments Overall Impact Subscale: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment*time as fixed effects, baseline and baseline*time as covariates.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -1.34
Confidence Interval (2-Sided) 90%
-2.39 to -0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments Overall Impact Subscale: Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.111
Comments MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment*time as fixed effects, baseline and baseline*time as covariates.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -0.86
Confidence Interval (2-Sided) 90%
-2.02 to 0.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.70
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in the Fibromyalgia Impact Questionnaire Revised (FIQR) FIQR Function, Symptoms, and Overall Impact Subscales
Hide Description 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).
Time Frame Baseline and EOT (Up to week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with LOCF Imputation.
Arm/Group Title Placebo ASP0819 15 mg
Hide Arm/Group Description:
Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Overall Number of Participants Analyzed 94 90
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Function Subscale: EOT -10.41  (1.66) -13.55  (1.70)
Symptom Subscale: EOT -10.79  (1.52) -14.07  (1.56)
Overall Impact Subscale: EOT -3.40  (0.46) -4.48  (0.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments Function Subscale
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value -3.15
Confidence Interval (2-Sided) 90%
-7.05 to 0.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments Symptoms subscale
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.065
Comments ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value -3.29
Confidence Interval (2-Sided) 90%
-6.85 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments Overall Impact Subscale.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value -1.08
Confidence Interval (2-Sided) 90%
-2.15 to -0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.65
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC)
Hide Description 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".
Time Frame Weeks 2, 4, and EOT (Up to week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with LOCF imputation.
Arm/Group Title Placebo ASP0819 15 mg
Hide Arm/Group Description:
Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Overall Number of Participants Analyzed 94 90
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2: Very much improved 3.2 2.2
Week 2: Much Improved 9.6 12.2
Week 2: Minimally Improved 31.9 42.2
Week 2: No Change 44.7 34.4
Week 2: Minimally Worse 7.4 3.3
Week 2: Much Worse 2.1 4.4
Week 2: Very Much Worse 1.1 1.1
Week 4: Very much improved 3.2 4.4
Week 4: Much Improved 14.9 20.0
Week 4: Minimally Improved 31.9 28.9
Week 4: No Change 33.0 37.8
Week 4: Minimally Worse 13.8 3.3
Week 4: Much Worse 3.2 4.4
Week 4: Very Much Worse 0 1.1
Week EOT: Very much improved 6.4 10.0
Week EOT: Much Improved 18.1 21.1
Week EOT: Minimally Improved 26.6 21.1
Week EOT: No Change 38.3 40.0
Week EOT: Minimally Worse 8.5 3.3
Week EOT: Much Worse 2.1 3.3
Week EOT: Very Much Worse 0 1.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments Week 2
Type of Statistical Test Superiority
Comments The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.
Statistical Test of Hypothesis P-Value 0.192
Comments [Not Specified]
Method Likelihood test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.43
Confidence Interval (2-Sided) 90%
0.91 to 2.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.285
Comments The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.
Method Likelihod test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.33
Confidence Interval (2-Sided) 90%
0.86 to 2.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments EOT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.486
Comments The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.
Method Likelihood test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.20
Confidence Interval (2-Sided) 90%
0.78 to 1.87
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants With Overall Participant Improvement Assessed by Patient Global Impression of Change (PGIC)
Hide Description 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".
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with modified last observation carried forward (mLOCF) imputation.
Arm/Group Title Placebo ASP0819 15 mg
Hide Arm/Group Description:
Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks.
Participants received ASP0819 15 mg capsules, orally, once daily in the morning, with or without food for 8 weeks.
Overall Number of Participants Analyzed 94 90
Measure Type: Number
Unit of Measure: Percentage of participants
Week 8: Very much improved 6.4 10.0
Week 8: Much Improved 18.1 21.1
Week 8: Minimally Improved 24.5 21.1
Week 8: No Change 40.4 42.2
Week 8: Minimally Worse 8.5 3.3
Week 8: Much Worse 2.1 2.2
Week 8: Very Much Worse 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, ASP0819 15 mg
Comments Week 8
Type of Statistical Test Superiority
Comments The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test.
Statistical Test of Hypothesis P-Value 0.305
Comments [Not Specified]
Method Likelihood test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.32
Confidence Interval (2-Sided) 90%
0.85 to 2.05
Estimation Comments [Not Specified]
Time Frame From first dose of study drug until end of study (up to Day 85)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo ASP0819
Hide Arm/Group Description Participants received ASP0819 matching placebo capsules, orally, once daily in the morning, with or without food for 8 weeks. A single oral dose to be taken preferably in the morning with or without food
All-Cause Mortality
Placebo ASP0819
Affected / at Risk (%) Affected / at Risk (%)
Total   0/94 (0.00%)      0/90 (0.00%)    
Hide Serious Adverse Events
Placebo ASP0819
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/94 (0.00%)      0/90 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo ASP0819
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/94 (28.72%)      30/90 (33.33%)    
Gastrointestinal disorders     
Diarrhoea  1  6/94 (6.38%)  6 2/90 (2.22%)  2
Nausea  1  2/94 (2.13%)  2 5/90 (5.56%)  5
Infections and infestations     
Upper respiratory tract infection  1  4/94 (4.26%)  4 5/90 (5.56%)  5
Viral upper respiratory tract infection  1  5/94 (5.32%)  5 4/90 (4.44%)  4
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/94 (3.19%)  3 5/90 (5.56%)  7
Pain in extremity  1  3/94 (3.19%)  3 5/90 (5.56%)  5
Nervous system disorders     
Headache  1  11/94 (11.70%)  11 12/90 (13.33%)  20
1
Term from vocabulary, MedDRA 20
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosure
Organization: Astellas Pharma Global Development, Inc.
Phone: 800-888-7704
EMail: astellas.resultsdisclosure@astellas.com
Layout table for additonal information
Responsible Party: Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier: NCT03056690    
Other Study ID Numbers: 0819-CL-0201
First Submitted: February 15, 2017
First Posted: February 17, 2017
Results First Submitted: February 10, 2021
Results First Posted: March 3, 2021
Last Update Posted: March 3, 2021