Trial Outcomes & Findings for A Multicenter Assessment of ALD403 in Chronic Migraine (NCT NCT02275117)
NCT ID: NCT02275117
Last Updated: 2020-04-08
Results Overview
Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
665 participants
Primary outcome timeframe
12 Weeks
Results posted on
2020-04-08
Participant Flow
A total of 1552 participants signed the ICF, of which 665 participants met the entry criteria and were randomized into the trial.
Participant milestones
| Measure |
300 mg ALD403
Participants were randomized to receive a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
Participants were randomized to receive a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
Participants were randomized to receive a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
Participants were randomized to receive a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
Participants were randomized to receive a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
131
|
133
|
134
|
133
|
134
|
|
Overall Study
Randomized and Treated
|
120
|
123
|
122
|
130
|
121
|
|
Overall Study
COMPLETED
|
97
|
96
|
92
|
100
|
98
|
|
Overall Study
NOT COMPLETED
|
34
|
37
|
42
|
33
|
36
|
Reasons for withdrawal
| Measure |
300 mg ALD403
Participants were randomized to receive a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
Participants were randomized to receive a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
Participants were randomized to receive a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
Participants were randomized to receive a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
Participants were randomized to receive a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
6
|
7
|
5
|
2
|
10
|
|
Overall Study
Lost to Follow-up
|
11
|
16
|
15
|
16
|
8
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
7
|
3
|
3
|
|
Overall Study
Terminated by Sponsor
|
4
|
4
|
4
|
6
|
4
|
|
Overall Study
Worsening of Study Indication
|
0
|
1
|
2
|
0
|
0
|
|
Overall Study
Study Burden
|
5
|
4
|
7
|
5
|
7
|
|
Overall Study
Other
|
1
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A Multicenter Assessment of ALD403 in Chronic Migraine
Baseline characteristics by cohort
| Measure |
300 mg ALD403
n=121 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=122 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=122 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=130 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=121 Participants
Participants received a single placebo IV infusion on Day 0
|
Total
n=616 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
35.7 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
36.4 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
37.2 years
STANDARD_DEVIATION 9.2 • n=21 Participants
|
36.6 years
STANDARD_DEVIATION 19.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
535 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
81 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
101 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
105 Participants
n=21 Participants
|
515 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
114 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
547 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Region of Enrollment
New Zealand
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
11 participants
n=8 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=5 Participants
|
106 participants
n=7 Participants
|
107 participants
n=5 Participants
|
115 participants
n=4 Participants
|
99 participants
n=21 Participants
|
528 participants
n=8 Participants
|
|
Region of Enrollment
Georgia
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
9 participants
n=4 Participants
|
15 participants
n=21 Participants
|
58 participants
n=8 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
5 participants
n=21 Participants
|
19 participants
n=8 Participants
|
|
Baseline Migraine Days
< 20 days
|
84 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
430 Participants
n=8 Participants
|
|
Baseline Migraine Days
≥ 20 days
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
186 Participants
n=8 Participants
|
|
Medication Overuse Status
No
|
56 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
296 Participants
n=8 Participants
|
|
Medication Overuse Status
Yes
|
65 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
320 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
75% Migraine Responder Rate
|
38 Participants
|
37 Participants
|
33 Participants
|
33 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Weeks 1-12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
50% Migraine Responder Rate
|
65 Participants
|
65 Participants
|
65 Participants
|
54 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Weeks 1-12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
50% Headache Responder Rate
|
59 Participants
|
55 Participants
|
55 Participants
|
48 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Weeks 1-12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Participants with an average reduction in headache days of at least 100% over Weeks 1 to 12, as compared with baseline
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
100% Headache Responder Rate
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Weeks 1-12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Participants with an average reduction in migraine days of at least 100% over Weeks 1 to 12, as compared with baseline
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
100% Migraine Responder Rate
|
9 Participants
|
6 Participants
|
5 Participants
|
10 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Weeks 1-12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
The Change From Baseline in Monthly Headache Days, Weeks 1-12
|
-9.6 days
Standard Deviation 6.94
|
-8.9 days
Standard Deviation 6.79
|
-9.2 days
Standard Deviation 6.33
|
-7.5 days
Standard Deviation 6.93
|
-6.9 days
Standard Deviation 6.37
|
SECONDARY outcome
Timeframe: Weeks 1-12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
The Change From Baseline in Monthly Migraine Days, Weeks 1-12
|
-8.2 days
Standard Deviation 7.00
|
-7.7 days
Standard Deviation 6.87
|
-7.9 days
Standard Deviation 6.38
|
-6.7 days
Standard Deviation 6.80
|
-5.6 days
Standard Deviation 6.56
|
SECONDARY outcome
Timeframe: Weeks 1-12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
Change From Baseline in Percentage of Severe Migraines
|
-20.7 percentage of severe migraines
Standard Deviation 29.47
|
-15.9 percentage of severe migraines
Standard Deviation 27.38
|
-17.2 percentage of severe migraines
Standard Deviation 26.98
|
-16.1 percentage of severe migraines
Standard Deviation 29.80
|
-9.7 percentage of severe migraines
Standard Deviation 27.32
|
SECONDARY outcome
Timeframe: Weeks 9-12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
The change from baseline in percentage of headaches that are classified as severe over Weeks 9-12
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
Change From Baseline in Percentage of Severe Headaches
|
-19.91 percentage of severe headaches
Standard Deviation 25.800
|
-10.36 percentage of severe headaches
Standard Deviation 28.004
|
-12.17 percentage of severe headaches
Standard Deviation 30.197
|
-11.42 percentage of severe headaches
Standard Deviation 30.517
|
-6.48 percentage of severe headaches
Standard Deviation 27.211
|
SECONDARY outcome
Timeframe: Baseline to 12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
The HIT-6 measures the impact of headache on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact). A score of 60 or above is labeled as "severe".
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
The Change From Baseline to Week 12 in HIT-6 Total Score
|
-60.4 percentage of HIT-6 total score
|
-43.4 percentage of HIT-6 total score
|
-34.9 percentage of HIT-6 total score
|
-34.8 percentage of HIT-6 total score
|
-28.4 percentage of HIT-6 total score
|
SECONDARY outcome
Timeframe: Weeks 1-12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Headache Days
|
-46.12 percentage of headache days
Standard Deviation 31.481
|
-43.09 percentage of headache days
Standard Deviation 33.912
|
-44.37 percentage of headache days
Standard Deviation 28.620
|
-37.20 percentage of headache days
Standard Deviation 34.112
|
-34.02 percentage of headache days
Standard Deviation 30.970
|
SECONDARY outcome
Timeframe: Weeks 1-12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Migraine Days
|
-48.88 percentage of migraine days
Standard Deviation 41.243
|
-46.79 percentage of migraine days
Standard Deviation 40.983
|
-46.74 percentage of migraine days
Standard Deviation 36.588
|
-40.80 percentage of migraine days
Standard Deviation 40.133
|
-35.37 percentage of migraine days
Standard Deviation 41.100
|
SECONDARY outcome
Timeframe: Baseline to Week 49 (End of Study)Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
The median number of days after dosing a participant had the next migraine using the eDiary as the recall method
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
Time to First Migraine After Dosing
|
4.0 Days
Interval 3.0 to 5.0
|
4.0 Days
Interval 3.0 to 5.0
|
3.0 Days
Interval 2.0 to 5.0
|
4.0 Days
Interval 3.0 to 5.0
|
2.0 Days
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: Weeks 1-12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
The number of monthly migraine attacks summarized over Weeks 1-12. A migraine attack is defined as 1 continuously recorded migraine. One attack may result in multiple migraine days
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
Change From Baseline in Monthly Migraine Attacks, Weeks 1-12
|
-6.8 Migraine Attacks
Standard Deviation 5.4
|
-6.5 Migraine Attacks
Standard Deviation 4.9
|
-6.9 Migraine Attacks
Standard Deviation 5.0
|
-6.2 Migraine Attacks
Standard Deviation 5.2
|
-5.5 Migraine Attacks
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Weeks 1-12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
The number of monthly headache episodes as summarized over Weeks 1-12. A headache episode is defined as 1 continuously recorded headache. One episode may result in multiple headache days
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
Change From Baseline in Monthly Headache Episodes, Weeks 1-12
|
-8.2 Headache Episodes
Standard Deviation 5.54
|
-8.0 Headache Episodes
Standard Deviation 5.37
|
-8.3 Headache Episodes
Standard Deviation 5.55
|
-7.3 Headache Episodes
Standard Deviation 5.37
|
-7.0 Headache Episodes
Standard Deviation 5.13
|
SECONDARY outcome
Timeframe: Weeks 1-12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Migraine hours are the sum of the duration of migraines within 4 week intervals, and the average 4 week duration within 12 week intervals.
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
Change From Baseline in Monthly Migraine Hours, Weeks 1-12
|
-70.9 Migraine Hours
Standard Deviation 100.34
|
-64.2 Migraine Hours
Standard Deviation 114.58
|
-63.1 Migraine Hours
Standard Deviation 84.56
|
-49.2 Migraine Hours
Standard Deviation 103.83
|
-34.9 Migraine Hours
Standard Deviation 100.87
|
SECONDARY outcome
Timeframe: Weeks 1-12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals.
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
Change From Baseline in Monthly Headache Hours, Weeks 1-12
|
-73.9 Headache Hours
Standard Deviation 101.53
|
-60.9 Headache Hours
Standard Deviation 114.77
|
-62.9 Headache Hours
Standard Deviation 81.89
|
-47.5 Headache Hours
Standard Deviation 102.84
|
-38.7 Headache Hours
Standard Deviation 99.26
|
SECONDARY outcome
Timeframe: Weeks 9-12The percent of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication
|
-15.43 percentage of acute medication migraines
Standard Deviation 39.121
|
-10.36 percentage of acute medication migraines
Standard Deviation 43.890
|
-4.44 percentage of acute medication migraines
Standard Deviation 37.746
|
-10.03 percentage of acute medication migraines
Standard Deviation 40.460
|
-9.60 percentage of acute medication migraines
Standard Deviation 37.451
|
SECONDARY outcome
Timeframe: Weeks 9-12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
The percent of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication
|
-5.98 percentage of acute medication headaches
Standard Deviation 34.144
|
-3.27 percentage of acute medication headaches
Standard Deviation 34.419
|
1.52 percentage of acute medication headaches
Standard Deviation 30.013
|
-3.14 percentage of acute medication headaches
Standard Deviation 32.853
|
-3.42 percentage of acute medication headaches
Standard Deviation 32.890
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
The SF-36 is a health survey containing 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks (range: 0=worst to 100=best). Increases from baseline indicate improvement.
Outcome measures
| Measure |
300 mg ALD403
n=114 Participants
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=118 Participants
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=117 Participants
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=123 Participants
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=116 Participants
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Physical Functioning - Baseline
|
50.5 SF-36 Score
Standard Deviation 8.7
|
50.6 SF-36 Score
Standard Deviation 7.8
|
51.1 SF-36 Score
Standard Deviation 7.6
|
50.3 SF-36 Score
Standard Deviation 8.4
|
50.2 SF-36 Score
Standard Deviation 6.5
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Physical Functioning - Week 12
|
53.6 SF-36 Score
Standard Deviation 5.0
|
51.2 SF-36 Score
Standard Deviation 8.3
|
52.5 SF-36 Score
Standard Deviation 7.2
|
51.3 SF-36 Score
Standard Deviation 7.9
|
51.9 SF-36 Score
Standard Deviation 6.1
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Role Physical - Baseline
|
43.9 SF-36 Score
Standard Deviation 9.5
|
45.2 SF-36 Score
Standard Deviation 9.3
|
45.6 SF-36 Score
Standard Deviation 9.3
|
44.9 SF-36 Score
Standard Deviation 9.9
|
44.3 SF-36 Score
Standard Deviation 9.6
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Role Physical - Week 12
|
50.9 SF-36 Score
Standard Deviation 7.2
|
48.9 SF-36 Score
Standard Deviation 9.3
|
49.9 SF-36 Score
Standard Deviation 7.7
|
47.9 SF-36 Score
Standard Deviation 9.9
|
48.5 SF-36 Score
Standard Deviation 8.3
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Bodily Pain -Baseline
|
42.7 SF-36 Score
Standard Deviation 9.5
|
42.7 SF-36 Score
Standard Deviation 9.6
|
44.5 SF-36 Score
Standard Deviation 9.9
|
43.0 SF-36 Score
Standard Deviation 9.6
|
42.5 SF-36 Score
Standard Deviation 9.4
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Bodily Pain - Week 12
|
48.9 SF-36 Score
Standard Deviation 8.4
|
46.5 SF-36 Score
Standard Deviation 9.9
|
48.1 SF-36 Score
Standard Deviation 9.2
|
46.6 SF-36 Score
Standard Deviation 9.3
|
46.0 SF-36 Score
Standard Deviation 9.5
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
General Health - Baseline
|
50.4 SF-36 Score
Standard Deviation 9.2
|
50.7 SF-36 Score
Standard Deviation 9.8
|
50.9 SF-36 Score
Standard Deviation 8.7
|
51.1 SF-36 Score
Standard Deviation 9.5
|
50.7 SF-36 Score
Standard Deviation 9.8
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
General Health - Week 12
|
51.8 SF-36 Score
Standard Deviation 8.7
|
50.7 SF-36 Score
Standard Deviation 10.2
|
50.7 SF-36 Score
Standard Deviation 9.2
|
52.7 SF-36 Score
Standard Deviation 9.8
|
50.6 SF-36 Score
Standard Deviation 10.0
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Vitality - Baseline
|
48.3 SF-36 Score
Standard Deviation 8.9
|
50.1 SF-36 Score
Standard Deviation 10.6
|
49.6 SF-36 Score
Standard Deviation 9.8
|
49.4 SF-36 Score
Standard Deviation 10.1
|
48.1 SF-36 Score
Standard Deviation 10.9
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Vitality - Week 12
|
51.3 SF-36 Score
Standard Deviation 7.8
|
50.9 SF-36 Score
Standard Deviation 10.5
|
50.6 SF-36 Score
Standard Deviation 11.3
|
50.7 SF-36 Score
Standard Deviation 10.6
|
51.1 SF-36 Score
Standard Deviation 10.2
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Social Functioning - Baseline
|
45.0 SF-36 Score
Standard Deviation 10.8
|
46.3 SF-36 Score
Standard Deviation 10.1
|
46.8 SF-36 Score
Standard Deviation 10.7
|
45.5 SF-36 Score
Standard Deviation 10.4
|
45.4 SF-36 Score
Standard Deviation 10.3
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Social Functioning - Week 12
|
50.5 SF-36 Score
Standard Deviation 8.1
|
48.7 SF-36 Score
Standard Deviation 10.1
|
49.5 SF-36 Score
Standard Deviation 9.0
|
47.7 SF-36 Score
Standard Deviation 9.8
|
48.1 SF-36 Score
Standard Deviation 8.7
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Role Emotional - Baseline
|
50.2 SF-36 Score
Standard Deviation 9.1
|
49.4 SF-36 Score
Standard Deviation 9.6
|
49.4 SF-36 Score
Standard Deviation 9.7
|
49.8 SF-36 Score
Standard Deviation 10.3
|
50.9 SF-36 Score
Standard Deviation 8.1
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Role Emotional - Week 12
|
51.4 SF-36 Score
Standard Deviation 8.2
|
50.2 SF-36 Score
Standard Deviation 9.0
|
51.2 SF-36 Score
Standard Deviation 7.2
|
50.9 SF-36 Score
Standard Deviation 8.4
|
51.0 SF-36 Score
Standard Deviation 8.3
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Mental Health - Baseline
|
51.4 SF-36 Score
Standard Deviation 8.4
|
52.0 SF-36 Score
Standard Deviation 9.3
|
51.8 SF-36 Score
Standard Deviation 9.5
|
51.4 SF-36 Score
Standard Deviation 9.5
|
50.8 SF-36 Score
Standard Deviation 9.8
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Mental Health - Week 12
|
52.1 SF-36 Score
Standard Deviation 8.8
|
50.8 SF-36 Score
Standard Deviation 10.1
|
51.2 SF-36 Score
Standard Deviation 9.5
|
52.2 SF-36 Score
Standard Deviation 9.5
|
52.4 SF-36 Score
Standard Deviation 8.8
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Mental Component Score - Baseline
|
50.4 SF-36 Score
Standard Deviation 9.4
|
50.9 SF-36 Score
Standard Deviation 9.7
|
50.5 SF-36 Score
Standard Deviation 9.6
|
50.4 SF-36 Score
Standard Deviation 9.9
|
50.5 SF-36 Score
Standard Deviation 9.0
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Mental Component Score - Week 12
|
51.2 SF-36 Score
Standard Deviation 9.0
|
50.5 SF-36 Score
Standard Deviation 9.7
|
50.7 SF-36 Score
Standard Deviation 9.4
|
51.3 SF-36 Score
Standard Deviation 9.3
|
51.5 SF-36 Score
Standard Deviation 8.9
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Physical Component Score - Baseline
|
45.5 SF-36 Score
Standard Deviation 8.4
|
46.1 SF-36 Score
Standard Deviation 8.4
|
47.1 SF-36 Score
Standard Deviation 7.7
|
46.1 SF-36 Score
Standard Deviation 8.3
|
45.5 SF-36 Score
Standard Deviation 7.9
|
|
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Physical Component Score - Week 12
|
51.2 SF-36 Score
Standard Deviation 6.8
|
49.0 SF-36 Score
Standard Deviation 8.6
|
50.1 SF-36 Score
Standard Deviation 7.0
|
48.8 SF-36 Score
Standard Deviation 8.5
|
48.4 SF-36 Score
Standard Deviation 8.1
|
Adverse Events
300 mg ALD403
Serious events: 7 serious events
Other events: 40 other events
Deaths: 0 deaths
100 mg ALD403
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
30 mg ALD403
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
10 mg ALD403
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
300 mg ALD403
n=121 participants at risk
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=122 participants at risk
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=122 participants at risk
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=130 participants at risk
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=122 participants at risk；n=121 participants at risk
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.82%
1/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.83%
1/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Infections and infestations
Vaginal abscess
|
0.83%
1/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.83%
1/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.83%
1/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.83%
1/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.82%
1/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Nervous system disorders
Convulsion
|
0.83%
1/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.82%
1/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Nervous system disorders
Serotonin syndrome
|
0.83%
1/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Psychiatric disorders
Substance-induced mood disorders
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.82%
1/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.77%
1/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.83%
1/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Psychiatric disorders
Menorrhagia
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.82%
1/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Renal and urinary disorders
Pelvic pain
|
0.83%
1/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Reproductive system and breast disorders
Respiratory distress
|
0.83%
1/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
Other adverse events
| Measure |
300 mg ALD403
n=121 participants at risk
Participants received a single 300 mg IV infusion of ALD403 on Day 0
|
100 mg ALD403
n=122 participants at risk
Participants received a single 100 mg IV infusion of ALD403 on Day 0
|
30 mg ALD403
n=122 participants at risk
Participants received a single 30 mg IV infusion of ALD403 on Day 0
|
10 mg ALD403
n=130 participants at risk
Participants received a single 10 mg IV infusion of ALD403 on Day 0
|
Placebo
n=122 participants at risk；n=121 participants at risk
Participants received a single placebo IV infusion on Day 0
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.6%
8/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
7.4%
9/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
3.3%
4/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
4.6%
6/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
7.4%
9/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Infections and infestations
Bronchitis
|
3.3%
4/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
3.3%
4/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
3.3%
4/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
3.1%
4/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
7.4%
9/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
9/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
6.6%
8/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
2.5%
3/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
4.6%
6/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
4.9%
6/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Infections and infestations
Sinusitis
|
6.6%
8/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
2.5%
3/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
4.9%
6/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
6.2%
8/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
4.9%
6/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.7%
13/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
6.6%
8/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
5.7%
7/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
6.9%
9/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
4.9%
6/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
6/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
2.5%
3/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.82%
1/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
3.1%
4/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
4.1%
5/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Nervous system disorders
Dizziness
|
1.7%
2/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
9.8%
12/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
2.5%
3/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
8.5%
11/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
7.4%
9/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Nervous system disorders
Migraine
|
0.83%
1/121 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
5.7%
7/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
2.5%
3/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
1.5%
2/130 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
1.6%
2/122 • Baseline to Week 49 (end of study)
3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place