Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability and Effectiveness of MT-0814 for the Treatment of Age-related Macular Degeneration (NCT NCT03869684)
NCT ID: NCT03869684
Last Updated: 2021-04-20
Results Overview
Change from Baseline in BCVA. BCVA was measured using an eye chart and is reported as number of letters read correctly using Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (0 to 100 letters) in study eye. Lower number of letters read correctly, worse the vision. Study eye: eye that meets inclusion criteria. If both eyes meet all inclusion and exclusion criteria, the eye with the lower BCVA at Screening will be selected as the study eye. If both eyes meet all inclusion criteria and have identical BCVA at Screening, selection of the study eye will be at the investigator's discretion.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2021-04-20
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Placebo manufactured to mimic MT-0814
|
MT-0814 Low Dose
MT-0814 plus placebo
MT-0814: Randomly assigned dose
Placebo: Placebo manufactured to mimic MT-0814
|
MT-0814 High Dose
MT-0814: Randomly assigned dose
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
5
|
|
Overall Study
COMPLETED
|
1
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Placebo manufactured to mimic MT-0814
|
MT-0814 Low Dose
MT-0814 plus placebo
MT-0814: Randomly assigned dose
Placebo: Placebo manufactured to mimic MT-0814
|
MT-0814 High Dose
MT-0814: Randomly assigned dose
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Study prematurely terminated by sponsor
|
0
|
0
|
2
|
Baseline Characteristics
A Study to Assess the Safety, Tolerability and Effectiveness of MT-0814 for the Treatment of Age-related Macular Degeneration
Baseline characteristics by cohort
| Measure |
Placebo
n=3 Participants
Placebo: Placebo manufactured to mimic MT-0814
|
MT-0814 Low Dose
n=5 Participants
MT-0814 plus placebo
MT-0814: Randomly assigned dose
Placebo: Placebo manufactured to mimic MT-0814
|
MT-0814 High Dose
n=5 Participants
MT-0814: Randomly assigned dose
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
13 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Whte
|
3 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
13 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=39 Participants
|
5 participants
n=41 Participants
|
5 participants
n=35 Participants
|
13 participants
n=31 Participants
|
|
Best-corrected Visual Acuity (BCVA) : Study eye
|
62.0 Letters
STANDARD_DEVIATION 10.82 • n=39 Participants
|
66.8 Letters
STANDARD_DEVIATION 7.98 • n=41 Participants
|
71.2 Letters
STANDARD_DEVIATION 4.15 • n=35 Participants
|
67.4 Letters
STANDARD_DEVIATION 7.74 • n=31 Participants
|
|
Central Subfield Thickness (CSFT) : Study eye
|
0.2990 mm
STANDARD_DEVIATION 0.04015 • n=39 Participants
|
0.3748 mm
STANDARD_DEVIATION 0.05981 • n=41 Participants
|
0.3954 mm
STANDARD_DEVIATION 0.08581 • n=35 Participants
|
0.3652 mm
STANDARD_DEVIATION 0.07369 • n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full-analysis set (FAS): The FAS consisted of all participants who were randomly assigned to receive double-masked study drug and who have received at least 1 dose of study drug. All analyses using the FAS grouped participants according to randomly assigned treatment.
Change from Baseline in BCVA. BCVA was measured using an eye chart and is reported as number of letters read correctly using Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (0 to 100 letters) in study eye. Lower number of letters read correctly, worse the vision. Study eye: eye that meets inclusion criteria. If both eyes meet all inclusion and exclusion criteria, the eye with the lower BCVA at Screening will be selected as the study eye. If both eyes meet all inclusion criteria and have identical BCVA at Screening, selection of the study eye will be at the investigator's discretion.
Outcome measures
| Measure |
Placebo
n=3 Participants
Placebo: Placebo manufactured to mimic MT-0814
|
MT-0814 Low Dose
n=5 Participants
MT-0814 plus placebo
MT-0814: Randomly assigned dose
Placebo: Placebo manufactured to mimic MT-0814
|
MT-0814 High Dose
n=5 Participants
MT-0814: Randomly assigned dose
|
|---|---|---|---|
|
Change in Best-corrected Visual Acuity (BCVA) : Study Eye
|
0.4 letters
Interval -7.7 to 8.5
|
0.3 letters
Interval -5.6 to 6.1
|
0.1 letters
Interval -6.1 to 6.3
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full-analysis set (FAS): The FAS consisted of all participants who were randomly assigned to receive double-masked study drug and who have received at least 1 dose of study drug. All analyses using the FAS grouped participants according to randomly assigned treatment.
Change from Baseline in CSFT, measured by Optical Coherence Tomography (OCT). Study eye: eye that meets inclusion criteria. If both eyes meet all inclusion and exclusion criteria, the eye with the lower BCVA at Screening will be selected as the study eye. If both eyes meet all inclusion criteria and have identical BCVA at Screening, selection of the study eye will be at the investigator's discretion.
Outcome measures
| Measure |
Placebo
n=3 Participants
Placebo: Placebo manufactured to mimic MT-0814
|
MT-0814 Low Dose
n=5 Participants
MT-0814 plus placebo
MT-0814: Randomly assigned dose
Placebo: Placebo manufactured to mimic MT-0814
|
MT-0814 High Dose
n=5 Participants
MT-0814: Randomly assigned dose
|
|---|---|---|---|
|
Change in Central Subfield Thickness (CSFT) : Study Eye
|
-0.0053 mm
Interval -0.0628 to 0.0523
|
-0.0016 mm
Interval -0.0412 to 0.038
|
0.0026 mm
Interval -0.0387 to 0.0438
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MT-0814 Low Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
MT-0814 High Dose
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=3 participants at risk
Placebo: Placebo manufactured to mimic MT-0814
|
MT-0814 Low Dose
n=5 participants at risk
MT-0814 plus placebo
MT-0814: Randomly assigned dose
Placebo: Placebo manufactured to mimic MT-0814
|
MT-0814 High Dose
n=5 participants at risk
MT-0814: Randomly assigned dose
|
|---|---|---|---|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Investigations
Liver function test increased
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
Other adverse events
| Measure |
Placebo
n=3 participants at risk
Placebo: Placebo manufactured to mimic MT-0814
|
MT-0814 Low Dose
n=5 participants at risk
MT-0814 plus placebo
MT-0814: Randomly assigned dose
Placebo: Placebo manufactured to mimic MT-0814
|
MT-0814 High Dose
n=5 participants at risk
MT-0814: Randomly assigned dose
|
|---|---|---|---|
|
Nervous system disorders
Migraine
|
33.3%
1/3 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Eye disorders
Cataract nuclear
|
33.3%
1/3 • Number of events 2 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Eye disorders
Eye pain
|
33.3%
1/3 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
1/3 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Eye disorders
Neovascular age-related macular degneration
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Eye disorders
Subretinal fluid
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 2 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 2 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 2 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 2 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Eye disorders
Dry age-related macular degeneration
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Nervous system disorders
Tension headach
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
|
Investigations
High density lipoprotein decreased
|
0.00%
0/3 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
0.00%
0/5 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
20.0%
1/5 • Number of events 1 • 16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
|
Additional Information
Director, Clinical Development
Senju Pharmaceutical Co. Ltd.
Phone: +81 078 777 1018
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place