We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Multicenter Assessment of ALD403 in Chronic Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02275117
Recruitment Status : Completed
First Posted : October 27, 2014
Results First Posted : March 30, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Migraine Disorders
Interventions Biological: ALD403
Biological: Placebo
Enrollment 665
Recruitment Details  
Pre-assignment Details A total of 1552 participants signed the ICF, of which 665 participants met the entry criteria and were randomized into the trial.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description Participants were randomized to receive a single 300 mg IV infusion of ALD403 on Day 0 Participants were randomized to receive a single 100 mg IV infusion of ALD403 on Day 0 Participants were randomized to receive a single 30 mg IV infusion of ALD403 on Day 0 Participants were randomized to receive a single 10 mg IV infusion of ALD403 on Day 0 Participants were randomized to receive a single placebo IV infusion on Day 0
Period Title: Overall Study
Started 131 133 134 133 134
Randomized and Treated [1] 120 123 122 130 121
Completed 97 96 92 100 98
Not Completed 34 37 42 33 36
Reason Not Completed
Adverse Event             0             0             0             0             1
Lack of Efficacy             6             7             5             2             10
Lost to Follow-up             11             16             15             16             8
Physician Decision             0             1             1             0             1
Protocol Violation             1             0             1             1             0
Withdrawal by Subject             6             4             7             3             3
Terminated by Sponsor             4             4             4             6             4
Worsening of Study Indication             0             1             2             0             0
Study Burden             5             4             7             5             7
Other             1             0             0             0             2
[1]
3 participants received duplicate randomization, participants are summarized in first group assigned
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo Total
Hide Arm/Group Description Participants received a single 300 mg IV infusion of ALD403 on Day 0 Participants received a single 100 mg IV infusion of ALD403 on Day 0 Participants received a single 30 mg IV infusion of ALD403 on Day 0 Participants received a single 10 mg IV infusion of ALD403 on Day 0 Participants received a single placebo IV infusion on Day 0 Total of all reporting groups
Overall Number of Baseline Participants 121 122 122 130 121 616
Hide Baseline Analysis Population Description
Safety population includes all subjects who received investigational product or placebo. 3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants 122 participants 122 participants 130 participants 121 participants 616 participants
37.2  (10.0) 36.7  (9.4) 35.7  (9.4) 36.4  (10.3) 37.2  (9.2) 36.6  (19.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 122 participants 122 participants 130 participants 121 participants 616 participants
Female
98
  81.0%
104
  85.2%
111
  91.0%
113
  86.9%
109
  90.1%
535
  86.9%
Male
23
  19.0%
18
  14.8%
11
   9.0%
17
  13.1%
12
   9.9%
81
  13.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 122 participants 122 participants 130 participants 121 participants 616 participants
Hispanic or Latino
18
  14.9%
23
  18.9%
17
  13.9%
27
  20.8%
16
  13.2%
101
  16.4%
Not Hispanic or Latino
103
  85.1%
99
  81.1%
105
  86.1%
103
  79.2%
105
  86.8%
515
  83.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 122 participants 122 participants 130 participants 121 participants 616 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   0.8%
2
   1.5%
1
   0.8%
4
   0.6%
Asian
1
   0.8%
0
   0.0%
0
   0.0%
1
   0.8%
1
   0.8%
3
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   0.8%
0
   0.0%
0
   0.0%
1
   0.2%
Black or African American
4
   3.3%
12
   9.8%
14
  11.5%
12
   9.2%
7
   5.8%
49
   8.0%
White
114
  94.2%
108
  88.5%
103
  84.4%
113
  86.9%
109
  90.1%
547
  88.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   1.7%
2
   1.6%
3
   2.5%
2
   1.5%
3
   2.5%
12
   1.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 121 participants 122 participants 122 participants 130 participants 121 participants 616 participants
New Zealand 7 1 0 1 2 11
United States 101 106 107 115 99 528
Georgia 11 9 14 9 15 58
Australia 2 6 1 5 5 19
Baseline Migraine Days   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 122 participants 122 participants 130 participants 121 participants 616 participants
< 20 days
84
  69.4%
85
  69.7%
87
  71.3%
90
  69.2%
84
  69.4%
430
  69.8%
≥ 20 days
37
  30.6%
37
  30.3%
35
  28.7%
40
  30.8%
37
  30.6%
186
  30.2%
[1]
Measure Description: Number of migraine days per month
Medication Overuse Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 122 participants 122 participants 130 participants 121 participants 616 participants
No
56
  46.3%
62
  50.8%
57
  46.7%
64
  49.2%
57
  47.1%
296
  48.1%
Yes
65
  53.7%
60
  49.2%
65
  53.3%
66
  50.8%
64
  52.9%
320
  51.9%
[1]
Measure Description: Investigator judgement of medication overuse status.
1.Primary Outcome
Title 75% Migraine Responder Rate
Hide Description Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Measure Type: Count of Participants
Unit of Measure: Participants
38
  33.3%
37
  31.4%
33
  28.2%
33
  26.8%
24
  20.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 300 mg ALD403, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments 75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)
Statistical Test of Hypothesis P-Value 0.0330
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.6
Confidence Interval (2-Sided) 95%
1.3 to 24.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 100 mg ALD403, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments 75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)
Statistical Test of Hypothesis P-Value 0.0715
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.7
Confidence Interval (2-Sided) 95%
-0.5 to 21.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 30 mg ALD403, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments 75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)
Statistical Test of Hypothesis P-Value 0.2013
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.5
Confidence Interval (2-Sided) 95%
-3.5 to 18.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 10 mg ALD403, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments 75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)
Statistical Test of Hypothesis P-Value 0.2938
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.1
Confidence Interval (2-Sided) 95%
-4.6 to 16.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 50% Migraine Responder Rate
Hide Description Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Measure Type: Count of Participants
Unit of Measure: Participants
65
  57.0%
65
  55.1%
65
  55.6%
54
  43.9%
47
  40.5%
3.Secondary Outcome
Title 50% Headache Responder Rate
Hide Description Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Measure Type: Count of Participants
Unit of Measure: Participants
59
  51.8%
55
  46.6%
55
  47.0%
48
  39.0%
39
  33.6%
4.Secondary Outcome
Title 100% Headache Responder Rate
Hide Description Participants with an average reduction in headache days of at least 100% over Weeks 1 to 12, as compared with baseline
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Measure Type: Count of Participants
Unit of Measure: Participants
4
   3.5%
0
   0.0%
0
   0.0%
1
   0.8%
1
   0.9%
5.Secondary Outcome
Title 100% Migraine Responder Rate
Hide Description Participants with an average reduction in migraine days of at least 100% over Weeks 1 to 12, as compared with baseline
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Measure Type: Count of Participants
Unit of Measure: Participants
9
   7.9%
6
   5.1%
5
   4.3%
10
   8.1%
3
   2.6%
6.Secondary Outcome
Title The Change From Baseline in Monthly Headache Days, Weeks 1-12
Hide Description Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Mean (Standard Deviation)
Unit of Measure: days
-9.6  (6.94) -8.9  (6.79) -9.2  (6.33) -7.5  (6.93) -6.9  (6.37)
7.Secondary Outcome
Title The Change From Baseline in Monthly Migraine Days, Weeks 1-12
Hide Description Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Mean (Standard Deviation)
Unit of Measure: days
-8.2  (7.00) -7.7  (6.87) -7.9  (6.38) -6.7  (6.80) -5.6  (6.56)
8.Secondary Outcome
Title Change From Baseline in Percentage of Severe Migraines
Hide Description The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Mean (Standard Deviation)
Unit of Measure: percentage of severe migraines
-20.7  (29.47) -15.9  (27.38) -17.2  (26.98) -16.1  (29.80) -9.7  (27.32)
9.Secondary Outcome
Title Change From Baseline in Percentage of Severe Headaches
Hide Description The change from baseline in percentage of headaches that are classified as severe over Weeks 9-12
Time Frame Weeks 9-12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Mean (Standard Deviation)
Unit of Measure: percentage of severe headaches
-19.91  (25.800) -10.36  (28.004) -12.17  (30.197) -11.42  (30.517) -6.48  (27.211)
10.Secondary Outcome
Title The Change From Baseline to Week 12 in HIT-6 Total Score
Hide Description 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".
Time Frame Baseline to 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Measure Type: Number
Unit of Measure: percentage of HIT-6 total score
-60.4 -43.4 -34.9 -34.8 -28.4
11.Secondary Outcome
Title Percent Change From Baseline in Headache Days
Hide Description Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Mean (Standard Deviation)
Unit of Measure: percentage of headache days
-46.12  (31.481) -43.09  (33.912) -44.37  (28.620) -37.20  (34.112) -34.02  (30.970)
12.Secondary Outcome
Title Percent Change From Baseline in Migraine Days
Hide Description Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Mean (Standard Deviation)
Unit of Measure: percentage of migraine days
-48.88  (41.243) -46.79  (40.983) -46.74  (36.588) -40.80  (40.133) -35.37  (41.100)
13.Secondary Outcome
Title Time to First Migraine After Dosing
Hide Description The median number of days after dosing a participant had the next migraine using the eDiary as the recall method
Time Frame Baseline to Week 49 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Days
4.0
(3.0 to 5.0)
4.0
(3.0 to 5.0)
3.0
(2.0 to 5.0)
4.0
(3.0 to 5.0)
2.0
(1.0 to 3.0)
14.Secondary Outcome
Title Change From Baseline in Monthly Migraine Attacks, Weeks 1-12
Hide Description 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
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Mean (Standard Deviation)
Unit of Measure: Migraine Attacks
-6.8  (5.4) -6.5  (4.9) -6.9  (5.0) -6.2  (5.2) -5.5  (5.0)
15.Secondary Outcome
Title Change From Baseline in Monthly Headache Episodes, Weeks 1-12
Hide Description 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
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Mean (Standard Deviation)
Unit of Measure: Headache Episodes
-8.2  (5.54) -8.0  (5.37) -8.3  (5.55) -7.3  (5.37) -7.0  (5.13)
16.Secondary Outcome
Title Change From Baseline in Monthly Migraine Hours, Weeks 1-12
Hide Description Migraine hours are the sum of the duration of migraines within 4 week intervals, and the average 4 week duration within 12 week intervals.
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Mean (Standard Deviation)
Unit of Measure: Migraine Hours
-70.9  (100.34) -64.2  (114.58) -63.1  (84.56) -49.2  (103.83) -34.9  (100.87)
17.Secondary Outcome
Title Change From Baseline in Monthly Headache Hours, Weeks 1-12
Hide Description Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals.
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Mean (Standard Deviation)
Unit of Measure: Headache Hours
-73.9  (101.53) -60.9  (114.77) -62.9  (81.89) -47.5  (102.84) -38.7  (99.26)
18.Secondary Outcome
Title Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication
Hide Description The percent of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.
Time Frame Weeks 9-12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Mean (Standard Deviation)
Unit of Measure: percentage of acute medication migraines
-15.43  (39.121) -10.36  (43.890) -4.44  (37.746) -10.03  (40.460) -9.60  (37.451)
19.Secondary Outcome
Title Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication
Hide Description The percent of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.
Time Frame Weeks 9-12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Mean (Standard Deviation)
Unit of Measure: percentage of acute medication headaches
-5.98  (34.144) -3.27  (34.419) 1.52  (30.013) -3.14  (32.853) -3.42  (32.890)
20.Secondary Outcome
Title Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description:
Participants received a single 300 mg IV infusion of ALD403 on Day 0
Participants received a single 100 mg IV infusion of ALD403 on Day 0
Participants received a single 30 mg IV infusion of ALD403 on Day 0
Participants received a single 10 mg IV infusion of ALD403 on Day 0
Participants received a single placebo IV infusion on Day 0
Overall Number of Participants Analyzed 114 118 117 123 116
Mean (Standard Deviation)
Unit of Measure: SF-36 Score
Physical Functioning - Baseline 50.5  (8.7) 50.6  (7.8) 51.1  (7.6) 50.3  (8.4) 50.2  (6.5)
Physical Functioning - Week 12 53.6  (5.0) 51.2  (8.3) 52.5  (7.2) 51.3  (7.9) 51.9  (6.1)
Role Physical - Baseline 43.9  (9.5) 45.2  (9.3) 45.6  (9.3) 44.9  (9.9) 44.3  (9.6)
Role Physical - Week 12 50.9  (7.2) 48.9  (9.3) 49.9  (7.7) 47.9  (9.9) 48.5  (8.3)
Bodily Pain -Baseline 42.7  (9.5) 42.7  (9.6) 44.5  (9.9) 43.0  (9.6) 42.5  (9.4)
Bodily Pain - Week 12 48.9  (8.4) 46.5  (9.9) 48.1  (9.2) 46.6  (9.3) 46.0  (9.5)
General Health - Baseline 50.4  (9.2) 50.7  (9.8) 50.9  (8.7) 51.1  (9.5) 50.7  (9.8)
General Health - Week 12 51.8  (8.7) 50.7  (10.2) 50.7  (9.2) 52.7  (9.8) 50.6  (10.0)
Vitality - Baseline 48.3  (8.9) 50.1  (10.6) 49.6  (9.8) 49.4  (10.1) 48.1  (10.9)
Vitality - Week 12 51.3  (7.8) 50.9  (10.5) 50.6  (11.3) 50.7  (10.6) 51.1  (10.2)
Social Functioning - Baseline 45.0  (10.8) 46.3  (10.1) 46.8  (10.7) 45.5  (10.4) 45.4  (10.3)
Social Functioning - Week 12 50.5  (8.1) 48.7  (10.1) 49.5  (9.0) 47.7  (9.8) 48.1  (8.7)
Role Emotional - Baseline 50.2  (9.1) 49.4  (9.6) 49.4  (9.7) 49.8  (10.3) 50.9  (8.1)
Role Emotional - Week 12 51.4  (8.2) 50.2  (9.0) 51.2  (7.2) 50.9  (8.4) 51.0  (8.3)
Mental Health - Baseline 51.4  (8.4) 52.0  (9.3) 51.8  (9.5) 51.4  (9.5) 50.8  (9.8)
Mental Health - Week 12 52.1  (8.8) 50.8  (10.1) 51.2  (9.5) 52.2  (9.5) 52.4  (8.8)
Mental Component Score - Baseline 50.4  (9.4) 50.9  (9.7) 50.5  (9.6) 50.4  (9.9) 50.5  (9.0)
Mental Component Score - Week 12 51.2  (9.0) 50.5  (9.7) 50.7  (9.4) 51.3  (9.3) 51.5  (8.9)
Physical Component Score - Baseline 45.5  (8.4) 46.1  (8.4) 47.1  (7.7) 46.1  (8.3) 45.5  (7.9)
Physical Component Score - Week 12 51.2  (6.8) 49.0  (8.6) 50.1  (7.0) 48.8  (8.5) 48.4  (8.1)
Time Frame Baseline to Week 49 (end of study)
Adverse Event Reporting Description 3 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
 
Arm/Group Title 300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Hide Arm/Group Description Participants received a single 300 mg IV infusion of ALD403 on Day 0 Participants received a single 100 mg IV infusion of ALD403 on Day 0 Participants received a single 30 mg IV infusion of ALD403 on Day 0 Participants received a single 10 mg IV infusion of ALD403 on Day 0 Participants received a single placebo IV infusion on Day 0
All-Cause Mortality
300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/121 (0.00%)   0/122 (0.00%)   0/122 (0.00%)   0/130 (0.00%)   0/121 (0.00%) 
Hide Serious Adverse Events
300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/121 (5.79%)   4/122 (3.28%)   0/122 (0.00%)   1/130 (0.77%)   1/121 (0.83%) 
Hepatobiliary disorders           
Cholelithiasis † 1  0/121 (0.00%)  1/122 (0.82%)  0/122 (0.00%)  0/130 (0.00%)  0/121 (0.00%) 
Infections and infestations           
Gastroenteritis viral † 1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/130 (0.00%)  0/121 (0.00%) 
Vaginal abscess † 1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/130 (0.00%)  0/121 (0.00%) 
Injury, poisoning and procedural complications           
Concussion † 1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/130 (0.00%)  0/121 (0.00%) 
Head injury † 1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/130 (0.00%)  0/121 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Uterine leiomyoma † 1  1/121 (0.83%)  1/122 (0.82%)  0/122 (0.00%)  0/130 (0.00%)  0/121 (0.00%) 
Nervous system disorders           
Convulsion † 1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/130 (0.00%)  0/121 (0.00%) 
Headache † 1  0/121 (0.00%)  1/122 (0.82%)  0/122 (0.00%)  0/130 (0.00%)  0/121 (0.00%) 
Serotonin syndrome † 1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/130 (0.00%)  0/121 (0.00%) 
Psychiatric disorders           
Substance-induced mood disorders † 1  0/121 (0.00%)  1/122 (0.82%)  0/122 (0.00%)  0/130 (0.00%)  0/121 (0.00%) 
Suicidal ideation † 1  0/121 (0.00%)  0/122 (0.00%)  0/122 (0.00%)  1/130 (0.77%)  1/121 (0.83%) 
Menorrhagia † 1  0/121 (0.00%)  1/122 (0.82%)  0/122 (0.00%)  0/130 (0.00%)  0/121 (0.00%) 
Renal and urinary disorders           
Pelvic pain † 1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/130 (0.00%)  0/121 (0.00%) 
Reproductive system and breast disorders           
Respiratory distress † 1  1/121 (0.83%)  0/122 (0.00%)  0/122 (0.00%)  0/130 (0.00%)  0/121 (0.00%) 
1
Term from vocabulary, MedDRA 15.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
300 mg ALD403 100 mg ALD403 30 mg ALD403 10 mg ALD403 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   40/121 (33.06%)   38/122 (31.15%)   26/122 (21.31%)   35/130 (26.92%)   37/122 (30.33%) 
Gastrointestinal disorders           
Nausea † 1  8/121 (6.61%)  9/122 (7.38%)  4/122 (3.28%)  6/130 (4.62%)  9/122 (7.38%) 
Infections and infestations           
Bronchitis † 1  4/121 (3.31%)  4/122 (3.28%)  4/122 (3.28%)  4/130 (3.08%)  9/122 (7.38%) 
Nasopharyngitis † 1  9/121 (7.44%)  8/122 (6.56%)  3/122 (2.46%)  6/130 (4.62%)  6/122 (4.92%) 
Sinusitis † 1  8/121 (6.61%)  3/122 (2.46%)  6/122 (4.92%)  8/130 (6.15%)  6/122 (4.92%) 
Upper respiratory tract infection † 1  13/121 (10.74%)  8/122 (6.56%)  7/122 (5.74%)  9/130 (6.92%)  6/122 (4.92%) 
Urinary tract infection † 1  6/121 (4.96%)  3/122 (2.46%)  1/122 (0.82%)  4/130 (3.08%)  5/122 (4.10%) 
Nervous system disorders           
Dizziness † 1  2/121 (1.65%)  12/122 (9.84%)  3/122 (2.46%)  11/130 (8.46%)  9/122 (7.38%) 
Migraine † 1  1/121 (0.83%)  7/122 (5.74%)  3/122 (2.46%)  2/130 (1.54%)  2/122 (1.64%) 
1
Term from vocabulary, MedDRA 15.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Email contact via
Organization: H. Lundbeck A/S
Phone: +4536301311
EMail: LundbeckClinicalTrials@Lundbeck.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02275117    
Other Study ID Numbers: ALD403-CLIN-005
First Submitted: October 20, 2014
First Posted: October 27, 2014
Results First Submitted: March 16, 2020
Results First Posted: March 30, 2020
Last Update Posted: April 8, 2020