Trial Outcomes & Findings for A Multicenter Assessment of ALD403 in Frequent Episodic Migraine (NCT NCT02559895)
NCT ID: NCT02559895
Last Updated: 2020-05-14
Results Overview
Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
898 participants
Primary outcome timeframe
Week 1-12
Results posted on
2020-05-14
Participant Flow
A total of 2413 participants signed the ICF, of which 898 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 Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
Participants were randomized to receive a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
Participants were randomized to receive a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
Participants were randomized to receive a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
224
|
225
|
224
|
225
|
|
Overall Study
Participants Treated
|
222
|
221
|
223
|
222
|
|
Overall Study
COMPLETED
|
169
|
172
|
170
|
165
|
|
Overall Study
NOT COMPLETED
|
55
|
53
|
54
|
60
|
Reasons for withdrawal
| Measure |
300 mg ALD403
Participants were randomized to receive a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
Participants were randomized to receive a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
Participants were randomized to receive a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
Participants were randomized to receive a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
2
|
8
|
|
Overall Study
Lost to Follow-up
|
22
|
16
|
12
|
17
|
|
Overall Study
Physician Decision
|
1
|
1
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
16
|
9
|
20
|
9
|
|
Overall Study
Study Burden
|
10
|
16
|
12
|
22
|
|
Overall Study
Other
|
1
|
5
|
3
|
3
|
Baseline Characteristics
A Multicenter Assessment of ALD403 in Frequent Episodic Migraine
Baseline characteristics by cohort
| Measure |
300 mg ALD403
n=224 Participants
Participants were randomized to receive a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=223 Participants
Participants were randomized to receive a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=219 Participants
Participants were randomized to receive a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants were randomized to receive a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Total
n=888 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 11.72 • n=5 Participants
|
40.0 years
STANDARD_DEVIATION 10.66 • n=7 Participants
|
39.1 years
STANDARD_DEVIATION 11.54 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 11.67 • n=4 Participants
|
39.8 years
STANDARD_DEVIATION 11.39 • n=21 Participants
|
|
Sex: Female, Male
Female
|
199 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
186 Participants
n=4 Participants
|
749 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
139 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
161 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
184 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
188 Participants
n=4 Participants
|
727 Participants
n=21 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
105 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
187 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
181 Participants
n=4 Participants
|
744 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
185 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
185 Participants
n=4 Participants
|
748 Participants
n=21 Participants
|
|
Region of Enrollment
Georgia
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Number of migraine days
|
7.8 Days
STANDARD_DEVIATION 2.59 • n=5 Participants
|
7.5 Days
STANDARD_DEVIATION 2.60 • n=7 Participants
|
7.9 Days
STANDARD_DEVIATION 2.70 • n=5 Participants
|
7.5 Days
STANDARD_DEVIATION 2.42 • n=4 Participants
|
7.7 Days
STANDARD_DEVIATION 2.58 • n=21 Participants
|
PRIMARY outcome
Timeframe: Week 1-12Population: Full Analysis Population - all randomized participants who received investigational product or placebo
Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12
Outcome measures
| Measure |
300 mg ALD403
n=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Change From Baseline in Monthly Migraine Days (Weeks 1-12)
|
-4.3 Migraine Days
Standard Deviation 3.42
|
-3.9 Migraine Days
Standard Deviation 3.23
|
-4.1 Migraine Days
Standard Deviation 3.22
|
-3.1 Migraine Days
Standard Deviation 3.70
|
SECONDARY outcome
Timeframe: Week 1-12Population: Full Analysis Population - all randomized participants who received investigational product or placebo
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=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
75% Migraine Responder Rate
|
66 Participants
|
49 Participants
|
55 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Week 1-4Population: Full Analysis Population - all randomized participants who received investigational product or placebo
Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 4, as compared with baseline.
Outcome measures
| Measure |
300 mg ALD403
n=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
75% Migraine Responder Rate
|
70 Participants
|
68 Participants
|
67 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Week 1-12Population: Full Analysis Population - all randomized participants who received investigational product or placebo
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=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
50% Migraine Responder Rate
|
125 Participants
|
110 Participants
|
112 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Full Analysis Population - all randomized participants who received investigational product or placebo
The percentage of participants with a migraine on the day after dosing, where Day 0 is treatment day and Day 1 is the day after dosing
Outcome measures
| Measure |
300 mg ALD403
n=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Percentage of Participants With a Migraine on the Day After Dosing
|
13.9 Percentage of participants
|
14.8 Percentage of participants
|
17.3 Percentage of participants
|
22.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 1-12Population: Full Analysis Population - all randomized participants who received investigational product or placebo
Participants with an average reduction in headache days of at least 75% over Weeks 1 to 12, as compared with baseline.
Outcome measures
| Measure |
300 mg ALD403
n=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
75% Headache Responder Rate
|
42 Participants
|
28 Participants
|
34 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Week 1-12Population: Full Analysis Population - all randomized participants who received investigational product or placebo
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=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
50% Headache Responder Rate
|
113 Participants
|
98 Participants
|
98 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: Week 1-12Population: Full Analysis Population - all randomized participants who received investigational product or placebo
Participants with a reduction in migraine days of 100% over Weeks 1 to 12, as compared with baseline
Outcome measures
| Measure |
300 mg ALD403
n=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
100% Migraine Responder Rate
|
9 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 1-12Population: Full Analysis Population - all randomized participants who received investigational product or placebo
Participants with a reduction in headache days of 100% over Weeks 1 to 12, as compared with baseline.
Outcome measures
| Measure |
300 mg ALD403
n=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
100% Headache Responder Rate
|
6 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 1-12Population: Full Analysis Population - all randomized participants who received investigational product or placebo
The change in number of days with any triptan or ergotamine use as recorded in the eDiary.
Outcome measures
| Measure |
300 mg ALD403
n=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Change From Baseline in Acute Migraine Medication Days (Weeks 1-12)
|
-0.8 days
Standard Deviation 1.77
|
-0.9 days
Standard Deviation 2.00
|
-0.6 days
Standard Deviation 1.62
|
-0.4 days
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Full Analysis Population - all randomized participants who received investigational product or placebo
The change in the percentage of days where a participant has a migraine from baseline to Week 4.
Outcome measures
| Measure |
300 mg ALD403
n=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Change From Baseline in Average Daily Migraine Prevalence to Week 4
|
-14.9 percentage of days with migraine
Standard Deviation 19.78
|
-13.8 percentage of days with migraine
Standard Deviation 19.27
|
-15.1 percentage of days with migraine
Standard Deviation 17.83
|
-9.7 percentage of days with migraine
Standard Deviation 19.33
|
SECONDARY outcome
Timeframe: Week 1-12Population: Full Analysis Population - all randomized participants who received investigational product or placebo
The percentage 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=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication
|
62.08 percentage of acute medication migraines
Standard Deviation 38.46
|
66.58 percentage of acute medication migraines
Standard Deviation 34.13
|
69.11 percentage of acute medication migraines
Standard Deviation 33.72
|
71.44 percentage of acute medication migraines
Standard Deviation 34.59
|
SECONDARY outcome
Timeframe: Week 1-12Population: Full Analysis Population - all randomized participants who received investigational product or placebo
The percentage 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=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication
|
63.09 percentage of acute medication headaches
Standard Deviation 36.87
|
66.85 percentage of acute medication headaches
Standard Deviation 33.65
|
67.84 percentage of acute medication headaches
Standard Deviation 33.59
|
70.95 percentage of acute medication headaches
Standard Deviation 33.43
|
SECONDARY outcome
Timeframe: Week 1-12Population: Full Analysis Population - all randomized participants who received investigational product or placebo
Monthly headache days are summarized in 28-day intervals, and averaged across Weeks 1-12.
Outcome measures
| Measure |
300 mg ALD403
n=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Change From Baseline in Monthly Headache Days (Weeks 1-12)
|
-4.5 headache days
Standard Deviation 3.96
|
-4.0 headache days
Standard Deviation 3.30
|
-4.4 headache days
Standard Deviation 3.24
|
-3.3 headache days
Standard Deviation 3.51
|
SECONDARY outcome
Timeframe: Week 1-12Population: Full Analysis Population - all randomized participants who received investigational product or placebo
Summary of percent of headaches with severe intensity over Weeks 1-12.
Outcome measures
| Measure |
300 mg ALD403
n=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Percent of Headaches With Severe Intensity
|
17.06 percentage of severe intensity headaches
Standard Deviation 22.03
|
19.84 percentage of severe intensity headaches
Standard Deviation 24.83
|
21.20 percentage of severe intensity headaches
Standard Deviation 26.60
|
21.68 percentage of severe intensity headaches
Standard Deviation 22.67
|
SECONDARY outcome
Timeframe: Week 1-12Population: Full Analysis Population - all randomized participants who received investigational product or placebo
Summary of percent of migraines with severe intensity over Week 1-12.
Outcome measures
| Measure |
300 mg ALD403
n=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Percent of Migraines With Severe Intensity
|
19.07 percentage of severe intensity migraines
Standard Deviation 23.46
|
22.23 percentage of severe intensity migraines
Standard Deviation 26.30
|
24.43 percentage of severe intensity migraines
Standard Deviation 28.15
|
26.01 percentage of severe intensity migraines
Standard Deviation 24.99
|
SECONDARY outcome
Timeframe: Week 1-12Migraine 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=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Change From Baseline in Monthly Migraine Hours (Weeks 1-12)
|
-42.9 migraine hours
Standard Deviation 49.91
|
-35.3 migraine hours
Standard Deviation 47.85
|
-37.8 migraine hours
Standard Deviation 50.17
|
-23.8 migraine hours
Standard Deviation 50.91
|
SECONDARY outcome
Timeframe: Week 1-12Headache 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=222 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=221 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=223 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Change From Baseline in Monthly Headache Hours, Weeks 1-12
|
-42.0 headache hours
Standard Deviation 56.67
|
-34.2 headache hours
Standard Deviation 49.19
|
-38.8 headache hours
Standard Deviation 50.45
|
-24.5 headache hours
Standard Deviation 48.15
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full Analysis Population - all randomized participants who received investigational product or placebo. The Week 12 scores only include participants who completed the Week 12 visit.
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. All scales are on a range of 0 to 100, with 0 being the worst and 100 being the best. Scales are reported separately. Increases from baseline indicate improvement.
Outcome measures
| Measure |
300 mg ALD403
n=211 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=208 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=205 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=201 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores
Role Physical
|
3.0 score on a scale
Standard Deviation 6.54
|
2.3 score on a scale
Standard Deviation 7.65
|
2.4 score on a scale
Standard Deviation 7.72
|
2.2 score on a scale
Standard Deviation 6.78
|
|
Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores
General Health
|
1.2 score on a scale
Standard Deviation 6.78
|
0.7 score on a scale
Standard Deviation 7.22
|
0.6 score on a scale
Standard Deviation 7.54
|
0.0 score on a scale
Standard Deviation 6.52
|
|
Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores
Vitality
|
2.3 score on a scale
Standard Deviation 7.91
|
1.8 score on a scale
Standard Deviation 8.36
|
0.2 score on a scale
Standard Deviation 8.61
|
1.7 score on a scale
Standard Deviation 7.43
|
|
Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores
Physical Functioning
|
0.9 score on a scale
Standard Deviation 5.78
|
1.2 score on a scale
Standard Deviation 6.88
|
0.9 score on a scale
Standard Deviation 6.74
|
0.3 score on a scale
Standard Deviation 6.43
|
|
Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores
Bodily Pain
|
4.5 score on a scale
Standard Deviation 8.27
|
4.3 score on a scale
Standard Deviation 8.37
|
3.5 score on a scale
Standard Deviation 9.12
|
2.3 score on a scale
Standard Deviation 8.70
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Population - all randomized participants who received investigational product or placebo. The Week 12 scores only include participants who completed the Week 12 visit.
The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of 5 dimension/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.
Outcome measures
| Measure |
300 mg ALD403
n=208 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=206 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=201 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=198 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Mobility · Extreme problems
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Mobility · Slight problems
|
21 Participants
|
18 Participants
|
16 Participants
|
15 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Mobility · Moderate problems
|
4 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Mobility · Severe problems
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Self-care · No problems
|
206 Participants
|
201 Participants
|
198 Participants
|
195 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Self-care · Severe problems
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Self-care · Extreme problems
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Usual Activities · No problems
|
177 Participants
|
173 Participants
|
176 Participants
|
172 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Usual Activities · Moderate problems
|
2 Participants
|
10 Participants
|
3 Participants
|
7 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Usual Activities · Severe problems
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Pain/Discomfort · No problems
|
113 Participants
|
116 Participants
|
123 Participants
|
110 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Pain/Discomfort · Slight problems
|
75 Participants
|
65 Participants
|
57 Participants
|
68 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Anxiety/Depression · Severe problems
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Anxiety/Depression · Extreme problems
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Mobility · No problems
|
183 Participants
|
181 Participants
|
181 Participants
|
179 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Self-care · Slight problems
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Self-care · Moderate problems
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Usual Activities · Slight problems
|
29 Participants
|
22 Participants
|
21 Participants
|
19 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Usual Activities · Extreme problems
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Pain/Discomfort · Moderate problems
|
19 Participants
|
24 Participants
|
18 Participants
|
18 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Pain/Discomfort · Severe problems
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Pain/Discomfort · Extreme problems
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Anxiety/Depression · No problems
|
158 Participants
|
156 Participants
|
168 Participants
|
151 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Anxiety/Depression · Slight problems
|
46 Participants
|
38 Participants
|
24 Participants
|
38 Participants
|
|
Health Related Quality of Life (EQ-5D-5L) at Week 12
Anxiety/Depression · Moderate problems
|
3 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full Analysis Population - all randomized participants who received investigational product or placebo. The Week 12 scores only include participants who completed the Week 12 visit.
The ASC-12 includes 12 questions about the frequency of various allodynia symptoms in association with headache attacks. For individuals with more than one type of headache, questions are directed to the "most severe type of headache." Each item is measured in a Likert type scale option with response categories: "Does not apply to me", "never", "rarely", "less than half the time", and "half the time or more". ASC items were scored as 0 (i.e., never, rarely or does not apply to me), 1 (less than half the time), and 2 (half the time or more), yielding scores that ranged from 0 to 24. If a single item is missing, it is scored as a 0. If more than one item is missing the total score will be missing. The interpretation of the total score is, 0-2: none; 3-5: mild; 6-8: moderate; greater than or equal to 9: severe.
Outcome measures
| Measure |
300 mg ALD403
n=208 Participants
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=206 Participants
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=200 Participants
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=198 Participants
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score
|
-1.6 score on a scale
Standard Deviation 4.22
|
-1.8 score on a scale
Standard Deviation 3.90
|
-1.6 score on a scale
Standard Deviation 3.95
|
-1.7 score on a scale
Standard Deviation 4.33
|
Adverse Events
300 mg ALD403
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
100 mg ALD403
Serious events: 4 serious events
Other events: 44 other events
Deaths: 0 deaths
30 mg ALD403
Serious events: 4 serious events
Other events: 44 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
300 mg ALD403
n=224 participants at risk
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=223 participants at risk
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=219 participants at risk
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 participants at risk
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.45%
1/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.45%
1/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Hepatobiliary disorders
Hepatic Cholestatic
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.46%
1/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.45%
1/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Injury, poisoning and procedural complications
Abdominal Wound Dehiscence
|
0.45%
1/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Injury, poisoning and procedural complications
Postprocedural Complication
|
0.45%
1/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.45%
1/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Injury, poisoning and procedural complications
Stomal Hernia
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.46%
1/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.45%
1/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.46%
1/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/222 • Baseline to Week 56 (end of study)
2 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)
Benign Breast Neoplasm
|
0.45%
1/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/222 • Baseline to Week 56 (end of study)
2 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)
Breast Cancer
|
0.45%
1/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/222 • Baseline to Week 56 (end of study)
2 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)
Breast Cancer Stage II
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.45%
1/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.45%
1/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.45%
1/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.45%
1/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.45%
1/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.45%
1/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.46%
1/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.46%
1/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.45%
1/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.45%
1/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.45%
1/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Injury, poisoning and procedural complications
Postprocedural Constipation
|
0.00%
0/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.45%
1/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
0.00%
0/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
Other adverse events
| Measure |
300 mg ALD403
n=224 participants at risk
Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
100 mg ALD403
n=223 participants at risk
Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
30 mg ALD403
n=219 participants at risk
Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
Placebo
n=222 participants at risk
Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36).
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.2%
14/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
7.6%
17/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
6.4%
14/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
5.4%
12/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Infections and infestations
Sinusitis
|
4.9%
11/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
2.7%
6/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
3.2%
7/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
6.3%
14/222 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.3%
23/224 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
9.9%
22/223 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
11.4%
25/219 • Baseline to Week 56 (end of study)
2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
|
7.2%
16/222 • Baseline to Week 56 (end of study)
2 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