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A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication

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ClinicalTrials.gov Identifier: NCT03557931
Recruitment Status : Completed
First Posted : June 15, 2018
Results First Posted : October 27, 2020
Last Update Posted : October 27, 2020
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: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: ASP4345
Drug: placebo
Drug: risperidone
Drug: quetiapine
Drug: olanzapine
Drug: ziprasidone
Drug: aripiprazole
Drug: brexpiprazole
Drug: paliperidone
Drug: lurasidone
Enrollment 233
Recruitment Details  
Pre-assignment Details Participants who were 18 to 55 years of age (inclusive at screening) with stable schizophrenia or schizoaffective disorder with mild extrapyramidal symptoms on up to 2 antipsychotic therapies and who met inclusion criteria and none of the exclusion criteria were enrolled.
Arm/Group Title Placebo ASP4345 50 Milligrams (mg) ASP4345 150 mg
Hide Arm/Group Description Participants on stable doses of antipsychotic medication received ASP4345 placebo matching capsules, orally, once daily for 12 weeks. Participants on stable doses of antipsychotic medication received ASP4345 50 mg, capsules, orally, once daily for 12 weeks. Participants on stable doses of antipsychotic medication received ASP4345 150 mg, capsules, orally, once daily for 12 weeks.
Period Title: Overall Study
Started 100 65 68
Completed 69 46 55
Not Completed 31 19 13
Reason Not Completed
Adverse Event             4             6             1
Lost to Follow-up             4             4             1
Protocol Violation             1             4             1
Withdrawal by Subject             14             0             7
Miscellaneous             8             5             3
Arm/Group Title Placebo ASP4345 50 mg ASP4345 150 mg Total
Hide Arm/Group Description Participants on stable doses of antipsychotic medication received ASP4345 placebo matching capsules, orally, once daily for 12 weeks. Participants on stable doses of antipsychotic medication received ASP4345 50 mg, capsules, orally, once daily for 12 weeks. Participants on stable doses of antipsychotic medication received ASP4345 150 mg, capsules, orally, once daily for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 100 65 68 233
Hide Baseline Analysis Population Description
The Intent-to-Treat (ITT) analysis set consisted of all participants who were randomized into the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 65 participants 68 participants 233 participants
42.8  (9.1) 42.7  (9.2) 42.8  (9.9) 42.8  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 65 participants 68 participants 233 participants
Female
27
  27.0%
23
  35.4%
20
  29.4%
70
  30.0%
Male
73
  73.0%
42
  64.6%
48
  70.6%
163
  70.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 65 participants 68 participants 233 participants
Hispanic or Latino
14
  14.0%
3
   4.6%
4
   5.9%
21
   9.0%
Not Hispanic or Latino
86
  86.0%
62
  95.4%
64
  94.1%
212
  91.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 65 participants 68 participants 233 participants
American Indian or Alaska Native
1
   1.0%
1
   1.5%
0
   0.0%
2
   0.9%
Asian
2
   2.0%
1
   1.5%
4
   5.9%
7
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
72
  72.0%
48
  73.8%
47
  69.1%
167
  71.7%
White
24
  24.0%
14
  21.5%
17
  25.0%
55
  23.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.0%
1
   1.5%
0
   0.0%
2
   0.9%
MATRICS Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  T-score
Number Analyzed 99 participants 65 participants 68 participants 232 participants
32.6  (13.3) 34  (10.7) 33.7  (12.3) 33.3  (12.3)
[1]
Measure Description: The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB neurocognitive composite score is a standardized mean of the six domain scores (excluding social cognition). Raw scores are converted to age and sex adjusted t-scores which are standardized to normative data, and have a mean of 50 and standard deviation of 10 in the general healthy population. A higher score indicates less impairment.
[2]
Measure Analysis Population Description: ITT population with available data at baseline.
UPSA-2-ER Total Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 82 participants 59 participants 63 participants 204 participants
74.4  (16.7) 80.2  (13.2) 78.1  (15.5) 77.2  (15.5)
[1]
Measure Description: The University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) assesses the functional abilities of the participant with schizophrenia in 6 domains: household management, communication, financial skills, transportation, comprehension/planning and medication management. The UPSA-2-ER total score has a range from 0 to 105. A higher score indicates less impairment.
[2]
Measure Analysis Population Description: ITT population with available data at baseline.
1.Primary Outcome
Title Change From Baseline to Week 12/End of Treatment (EoT) in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score
Hide Description The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (i.e., working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB neurocognitive composite score is a standardized mean of the six domain scores (excluding social cognition). Raw scores are converted to age and sex adjusted t-scores which are standardized to normative data, and have a mean of 50 and standard deviation of 10 in the general healthy population. A higher score indicates less impairment.
Time Frame Baseline and week 12/end of treatment (EoT)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of study drug and had at least 1 postbaseline MCCB measurement. FAS population with available data at baseline and week12/EoT.
Arm/Group Title Placebo ASP4345 50 mg ASP4345 150 mg
Hide Arm/Group Description:
Participants on stable doses of antipsychotic medication received ASP4345 placebo matching capsules, orally, once daily for 12 weeks.
Participants on stable doses of antipsychotic medication received ASP4345 50 mg, capsules, orally, once daily for 12 weeks.
Participants on stable doses of antipsychotic medication received ASP4345 150 mg, capsules, orally, once daily for 12 weeks.
Overall Number of Participants Analyzed 67 45 51
Least Squares Mean (Standard Error)
Unit of Measure: T-score
1.15  (0.65) 1.34  (0.79) 0.87  (0.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, ASP4345 50 mg
Comments Mixed model repeated measures (MMRM) analysis model is performed with change from baseline (least square (LS) Mean estimate for observed value from separate model using observed values) at week 12 as response; treatment, site (pooled where necessary), visit, treatment*visit, and visit*baseline as fixed effects, and baseline as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.858
Comments [Not Specified]
Method MMRM Method
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.18
Confidence Interval (2-Sided) 90%
-1.51 to 1.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.02
Estimation Comments [Not Specified]
Other Statistical Analysis Cohen's d Effect Size was defined as: (t-value for the least squares mean pairwise difference of ASP4345 50 mg vs placebo) * sqrt(1/n[PLACEBO] + 1/n[ASP4345]). The Cohen's d Effect Size value for ASP4345 50 mg vs placebo is 0.035.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ASP4345 150 mg
Comments MMRM analysis model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at week 12 as response; treatment, site (pooled where necessary), visit, treatment*visit, and visit*baseline as fixed effects, and baseline as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 0.775
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.28
Confidence Interval (2-Sided) 90%
-1.93 to 1.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.99
Estimation Comments [Not Specified]
Other Statistical Analysis Cohen's d Effect Size was defined as: (t-value for the least squares mean pairwise difference of ASP4345 150 mg vs placebo) * sqrt(1/n[PLACEBO] + 1/n[ASP4345]). The Cohen's d Effect Size value for ASP4345 150 mg vs placebo is - 0.053.
2.Primary Outcome
Title Number of Participants With Adverse Event (AE)
Hide Description Treatment emergent adverse event (TEAE) is defined as an AE observed after starting administration of the study drug and 28 days after the last dose of study drug. A study drug-related TEAE is defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, metabolic parameters etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant.
Time Frame Baseline up to end of study (EoS) (week 14)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAF) consisted of all participants who took at least 1 dose of study drug.
Arm/Group Title Placebo ASP4345 50 mg ASP4345 150 mg
Hide Arm/Group Description:
Participants on stable doses of antipsychotic medication received ASP4345 placebo matching capsules, orally, once daily for 12 weeks.
Participants on stable doses of antipsychotic medication received ASP4345 50 mg, capsules, orally, once daily for 12 weeks.
Participants on stable doses of antipsychotic medication received ASP4345 150 mg, capsules, orally, once daily for 12 weeks.
Overall Number of Participants Analyzed 100 65 68
Measure Type: Number
Unit of Measure: participants
TEAE 45 28 28
Drug-Related TEAEs 11 13 11
Serious TEAEs 1 3 1
Drug-Related Serious TEAE 0 0 0
3.Primary Outcome
Title Number of Participants With Clinically Significant Differences in Columbia-Suicide Severity Rating Scale (C-SSRS) Values
Hide Description The C-SSRS is a questionnaire used for suicide risk assessment. Affirmative or negative responses are provided to items 1 to 5 for 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) and items 6 to 10 for suicide behavior (6. Preparatory acts or behavior, 7. Aborted attempt, 8. Interrupted attempt, 9. Actual attempt, 10. Completed suicide).
Time Frame Baseline up to EoS (week 14)
Hide Outcome Measure Data
Hide Analysis Population Description
SAF population
Arm/Group Title Placebo ASP4345 50 mg ASP4345 150 mg
Hide Arm/Group Description:
Participants on stable doses of antipsychotic medication received ASP4345 placebo matching capsules, orally, once daily for 12 weeks.
Participants on stable doses of antipsychotic medication received ASP4345 50 mg, capsules, orally, once daily for 12 weeks.
Participants on stable doses of antipsychotic medication received ASP4345 150 mg, capsules, orally, once daily for 12 weeks.
Overall Number of Participants Analyzed 100 65 68
Measure Type: Number
Unit of Measure: participants
0 0 0
4.Primary Outcome
Title Number of Participants With Clinically Significant Differences in Abnormal Involuntary Movement Scale (AIMS) Values
Hide Description AIMS is a 14-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 to 14 are yes/no questions regarding the global judgement and dental status of the participant. The total score is the sum of the scores for the 14 items and the possible total score ranges from 0 to 44. A higher total score is indicative of more severe dyskinetic movements.
Time Frame Baseline, week 6 and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
SAF population with available data at each time point.
Arm/Group Title Placebo ASP4345 50 mg ASP4345 150 mg
Hide Arm/Group Description:
Participants on stable doses of antipsychotic medication received ASP4345 placebo matching capsules, orally, once daily for 12 weeks.
Participants on stable doses of antipsychotic medication received ASP4345 50 mg, capsules, orally, once daily for 12 weeks.
Participants on stable doses of antipsychotic medication received ASP4345 150 mg, capsules, orally, once daily for 12 weeks.
Overall Number of Participants Analyzed 93 62 65
Measure Type: Number
Unit of Measure: participants
Baseline Number Analyzed 93 participants 62 participants 65 participants
0 0 0
Week 6 Number Analyzed 83 participants 55 participants 60 participants
0 0 0
Week 12 Number Analyzed 70 participants 46 participants 52 participants
0 0 0
5.Primary Outcome
Title Number of Participants With Clinically Significant Differences in Simpson Angus Scale (SAS) Values
Hide Description SAS scale consists of 10 items including 7 items that address bradykinesia-rigidity and additional single items for tremor, glabellar tap, and salivation. Each item represents a specific physical condition and is rated on a 5-point category rating scale ranging from 0 (complete absence of the condition) to 4 (the condition is present to an extreme degree).The total score is obtained by adding the scores for the 10 individual items making the maximum possible score is 40. Higher scores are indicative of more severe Parkinsonian-type symptoms.
Time Frame Baseline, week 6 and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
SAF population with available data at each time point.
Arm/Group Title Placebo ASP4345 50 mg ASP4345 150 mg
Hide Arm/Group Description:
Participants on stable doses of antipsychotic medication received ASP4345 placebo matching capsules, orally, once daily for 12 weeks.
Participants on stable doses of antipsychotic medication received ASP4345 50 mg, capsules, orally, once daily for 12 weeks.
Participants on stable doses of antipsychotic medication received ASP4345 150 mg, capsules, orally, once daily for 12 weeks.
Overall Number of Participants Analyzed 93 62 65
Measure Type: Number
Unit of Measure: participants
Baseline Number Analyzed 93 participants 62 participants 65 participants
0 0 0
Week 6 Number Analyzed 83 participants 55 participants 60 participants
0 0 0
Week 12 Number Analyzed 70 participants 46 participants 52 participants
0 0 0
6.Primary Outcome
Title Number of Participants With Clinically Significant Differences in Barnes Akathisia Rating Scale (BARS) Values
Hide Description BARS is used to rate observable, restless movements of drug induced akathisia and subjective awareness of restlessness and any distress associated with the akathisia. BARS consists of the following 4 items: objective assessment of akathisia symptoms, subjective assessment of the participants's awareness of inner restlessness, distress restlessness, and global clinical assessment of akathisia. First three items are rated on a 4-point scale ranging from 0 (no abnormal movements or absence of inner restlessness or no distress) to 3 (severe akathisia or awareness of intense compulsion to move most of the time or severe distress). The last item, the global clinical assessment of akathisia, is rated on a 6-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Total BARS score ranges from 0 to 14 with a higher score representing worse results.
Time Frame Baseline, week 6 and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
SAF population with available data at each time point.
Arm/Group Title Placebo ASP4345 50 mg ASP4345 150 mg
Hide Arm/Group Description:
Participants on stable doses of antipsychotic medication received ASP4345 placebo matching capsules, orally, once daily for 12 weeks.
Participants on stable doses of antipsychotic medication received ASP4345 50 mg, capsules, orally, once daily for 12 weeks.
Participants on stable doses of antipsychotic medication received ASP4345 150 mg, capsules, orally, once daily for 12 weeks.
Overall Number of Participants Analyzed 93 62 66
Measure Type: Number
Unit of Measure: participants
Baseline Number Analyzed 93 participants 62 participants 66 participants
0 0 0
Week 6 Number Analyzed 83 participants 55 participants 60 participants
0 0 0
Week 12 Number Analyzed 70 participants 46 participants 52 participants
0 0 0
7.Secondary Outcome
Title Change From Baseline to Week 12/EoT in University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) Total Score
Hide Description The UPSA-2-ER assesses the functional abilities of the participant with schizophrenia in 6 domains: household management, communication, financial skills, transportation, comprehension/planning and medication management. The UPSA-2-ER total score has a range from 0 to 105. A higher score indicates less impairment.
Time Frame Baseline and week 12/EoT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with available data at baseline and at week 12/EoT.
Arm/Group Title Placebo ASP4345 50 mg ASP4345 150 mg
Hide Arm/Group Description:
Participants on stable doses of antipsychotic medication received ASP4345 placebo matching capsules, orally, once daily for 12 weeks.
Participants on stable doses of antipsychotic medication received ASP4345 50 mg, capsules, orally, once daily for 12 weeks.
Participants on stable doses of antipsychotic medication received ASP4345 150 mg, capsules, orally, once daily for 12 weeks.
Overall Number of Participants Analyzed 55 40 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.11  (1.06) 3.86  (1.23) 2.56  (1.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, ASP4345 50 mg
Comments Analysis of covariance (ANCOVA) model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at the Week 12 timepoint as response, treatment and site (pooled where necessary) and baseline as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.639
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.75
Confidence Interval (2-Sided) 90%
-1.90 to 3.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ASP4345 150 mg
Comments ANCOVA model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at the Week 12 timepoint as response, treatment and site (pooled where necessary) and baseline as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.721
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.55
Confidence Interval (2-Sided) 90%
-3.11 to 2.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.54
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Concentration at Trough Level (Ctrough) for ASP4345
Hide Description Ctrough concentration for ASP4345 was reported.
Time Frame Predose: day 7, day 14, day 21, day 42 and day 84/EoT
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis set (PKAS) consisted of all participants who took at least 1 dose of study drug and who had at least 1 plasma concentration. PKAS population with available data at each time point.
Arm/Group Title ASP4345 50 mg ASP4345 150 mg
Hide Arm/Group Description:
Participants on stable doses of antipsychotic medication received ASP4345 50 mg, capsules, orally, once daily for 12 weeks.
Participants on stable doses of antipsychotic medication received ASP4345 150 mg, capsules, orally, once daily for 12 weeks.
Overall Number of Participants Analyzed 54 60
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Day 7 Pre-dose Number Analyzed 54 participants 60 participants
175.041  (159.345) 483.84  (452.65)
Day 14 Pre-dose Number Analyzed 48 participants 49 participants
182.903  (165.499) 428.88  (516.14)
Day 21 Pre-dose Number Analyzed 15 participants 17 participants
172.040  (128.812) 384.48  (331.71)
Day 42 Pre-dose Number Analyzed 46 participants 44 participants
207.145  (167.127) 471.78  (546.00)
Day 84 Pre-dose Number Analyzed 35 participants 39 participants
204.914  (154.615) 433.56  (427.12)
Time Frame Baseline up to EoS (week 14)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo ASP4345 50 mg ASP4345 150 mg
Hide Arm/Group Description Participants on stable doses of antipsychotic medication received ASP4345 placebo matching capsules, orally, once daily for 12 weeks. Participants on stable doses of antipsychotic medication received ASP4345 50 mg, capsules, orally, once daily for 12 weeks. Participants on stable doses of antipsychotic medication received ASP4345 150 mg, capsules, orally, once daily for 12 weeks.
All-Cause Mortality
Placebo ASP4345 50 mg ASP4345 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)      0/65 (0.00%)      0/68 (0.00%)    
Hide Serious Adverse Events
Placebo ASP4345 50 mg ASP4345 150 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/100 (1.00%)      3/65 (4.62%)      1/68 (1.47%)    
Injury, poisoning and procedural complications       
Head injury  1  0/100 (0.00%)  0 1/65 (1.54%)  1 0/68 (0.00%)  0
Psychiatric disorders       
Psychotic disorder  1  0/100 (0.00%)  0 1/65 (1.54%)  1 1/68 (1.47%)  1
Suicidal ideation  1  1/100 (1.00%)  2 0/65 (0.00%)  0 0/68 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure  1  0/100 (0.00%)  0 1/65 (1.54%)  1 0/68 (0.00%)  0
1
Term from vocabulary, MedDRA 18
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo ASP4345 50 mg ASP4345 150 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/100 (3.00%)      5/65 (7.69%)      7/68 (10.29%)    
Nervous system disorders       
Dizziness  1  0/100 (0.00%)  0 1/65 (1.54%)  1 4/68 (5.88%)  4
Headache  1  3/100 (3.00%)  3 4/65 (6.15%)  4 3/68 (4.41%)  3
1
Term from vocabulary, MedDRA 18
Indicates events were collected by systematic assessment
ASP4345 metabolites were optional and deemed not necessary.
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: NCT03557931    
Other Study ID Numbers: 4345-CL-0015
First Submitted: June 5, 2018
First Posted: June 15, 2018
Results First Submitted: October 2, 2020
Results First Posted: October 27, 2020
Last Update Posted: October 27, 2020