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An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine (PREVAIL)

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ClinicalTrials.gov Identifier: NCT02985398
Recruitment Status : Completed
First Posted : December 7, 2016
Results First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Migraine Disorder
Intervention Biological: ALD403 (Eptinezumab)
Enrollment 128
Recruitment Details  
Pre-assignment Details A total of 158 participants signed the ICF, of which 128 participants met the entry criteria and were randomized into the trial.
Arm/Group Title 300 mg ALD403
Hide Arm/Group Description Participants were enrolled and scheduled to receive 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Period Title: Overall Study
Started 128
Participants Treated 128
Completed 106
Not Completed 22
Reason Not Completed
Adverse Event             1
Lost to Follow-up             4
Withdrawal by Subject             8
Study Burden             9
Arm/Group Title 300 mg ALD403
Hide Arm/Group Description Participants were randomized to receive 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Overall Number of Baseline Participants 128
Hide Baseline Analysis Population Description
Safety Population includes all participants who received study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants
41.5  (11.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants
Female
109
  85.2%
Male
19
  14.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants
Hispanic or Latino
26
  20.3%
Not Hispanic or Latino
102
  79.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   3.1%
White
122
  95.3%
More than one race
1
   0.8%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 128 participants
128
Duration of migraine diagnosis at baseline  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants
21.2  (11.65)
1.Primary Outcome
Title Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)
Hide Description Treatment emergent adverse events were defined as adverse events with start date and time on or after the date and time of the initial study drug infusion.
Time Frame 104 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all participants who received study drug.
Arm/Group Title 300 mg ALD403
Hide Arm/Group Description:
Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Overall Number of Participants Analyzed 128
Measure Type: Count of Participants
Unit of Measure: Participants
91
  71.1%
2.Primary Outcome
Title Number of Participants With a Clinically Significant Electrocardiogram
Hide Description Overall investigator interpretation of participant electrocardiogram
Time Frame Baseline, Day 0 Postdose, Week 12, 24, 36, 48 60, 72 and 84 (Predose and Postdose), and Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all participants who received study drug.
Arm/Group Title 300 mg ALD403
Hide Arm/Group Description:
Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Overall Number of Participants Analyzed 128
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline
0
   0.0%
Day 0 Postdose
1
   0.8%
Week 12 Predose
0
   0.0%
Week 12 Postdose
0
   0.0%
Week 24 Predose
0
   0.0%
Week 24 Postdose
0
   0.0%
Week 36 Predose
0
   0.0%
Week 36 Postdose
0
   0.0%
Week 48 Predose
0
   0.0%
Week 48 Postdose
0
   0.0%
Week 60 Predose
1
   0.8%
Week 60 Postdose
1
   0.8%
Week 72 Predose
1
   0.8%
Week 72 Postdose
1
   0.8%
Week 84 Predose
1
   0.8%
Week 84 Postdose
0
   0.0%
Week 104
1
   0.8%
3.Primary Outcome
Title Number of Participants With Any Clinically Significant Laboratory Values
Hide Description Each of the laboratory values that were reported as abnormal and clinically significant and entered as adverse events in the database.
Time Frame 104 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all participants who received study drug.
Arm/Group Title 300 mg ALD403
Hide Arm/Group Description:
Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Overall Number of Participants Analyzed 128
Measure Type: Count of Participants
Unit of Measure: Participants
Hematocrit Decreased
1
   0.8%
Hemoglobin Decreased
1
   0.8%
Blood Glucose Increased
1
   0.8%
Hypertriglyceridemia
1
   0.8%
Blood Potassium Decreased
1
   0.8%
Hypokalemia
1
   0.8%
Blood Mercury Abnormal
1
   0.8%
Hypercholesterolemia
1
   0.8%
Hyperlipidemia
1
   0.8%
4.Primary Outcome
Title Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description Baseline responses are collected at screening and assess suicidal ideation in the past 6 months. Post baseline reports the worst assessment of suicidal ideation since the last visit for all post baseline visits.
Time Frame 104 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all participants who received study drug.
Arm/Group Title 300 mg ALD403
Hide Arm/Group Description:
Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Overall Number of Participants Analyzed 128
Measure Type: Count of Participants
Unit of Measure: Participants
Participants Experiencing Suicidal Ideation
0
   0.0%
Participants Experiencing Suicidal Behavior
0
   0.0%
5.Primary Outcome
Title Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs
Hide Description Changes in vital signs that were considered clinically meaningful or clinically significant (CS) by the Investigator
Time Frame 104 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all participants who received study drug.
Arm/Group Title 300 mg ALD403
Hide Arm/Group Description:
Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Overall Number of Participants Analyzed 128
Measure Type: Count of Participants
Unit of Measure: Participants
Number of CS changes in diastolic blood pressure
0
   0.0%
Number of CS changes in systolic blood pressure
0
   0.0%
Number of CS changes in heart rate value
0
   0.0%
6.Secondary Outcome
Title Patient Global Impression of Change (PGIC) at Week 104
Hide Description The PGIC includes a single question concerning the participant's impression of the change in their disease status since the start of the study. Seven responses are possible: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.
Time Frame Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all participants who received study drug. Only participants who completed the Week 104 Visit are included
Arm/Group Title 300 mg ALD403
Hide Arm/Group Description:
Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Overall Number of Participants Analyzed 96
Measure Type: Count of Participants
Unit of Measure: Participants
Very Much Improved
47
  49.0%
Much Improved
33
  34.4%
Minimally Improved
11
  11.5%
No Change
5
   5.2%
Minimally Worse
0
   0.0%
Much Worse
0
   0.0%
Very Much Worse
0
   0.0%
7.Secondary Outcome
Title Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores
Hide Description The SF-36 is a health survey consisting of 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks (scale 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
Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included
Arm/Group Title 300 mg ALD403
Hide Arm/Group Description:
Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: score on a scale
Bodily Pain 5.8  (10.06)
General Health 1.6  (6.46)
Mental Component 1.9  (7.89)
Mental Health 1.4  (7.86)
Physical Component 4.5  (7.08)
Physical Functioning 2.9  (6.15)
Role Emotional 2.3  (9.09)
Role Physical 4.8  (8.34)
Social Functioning 4.9  (9.13)
Vitality 3.0  (7.90)
8.Secondary Outcome
Title Health Related Quality of Life (EQ-5D-5L) at Week 12
Hide Description The EQ-5D-5L is a descriptive health-related quality of life states consisting of 5 dimensions/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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included
Arm/Group Title 300 mg ALD403
Hide Arm/Group Description:
Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Overall Number of Participants Analyzed 124
Measure Type: Count of Participants
Unit of Measure: Participants
Mobility No problems
110
  88.7%
Slight problems
11
   8.9%
Moderate problems
3
   2.4%
Severe problems
0
   0.0%
Extreme problems
0
   0.0%
Self-care No problems
121
  97.6%
Slight problems
3
   2.4%
Moderate problems
0
   0.0%
Severe problems
0
   0.0%
Extreme problems
0
   0.0%
Usual Activities No problems
95
  76.6%
Slight problems
18
  14.5%
Moderate problems
11
   8.9%
Severe problems
0
   0.0%
Extreme problems
0
   0.0%
Pain/Discomfort No problems
55
  44.4%
Slight problems
42
  33.9%
Moderate problems
22
  17.7%
Severe problems
5
   4.0%
Extreme problems
0
   0.0%
Anxiety/Depression No problems
96
  77.4%
Slight problems
22
  17.7%
Moderate problems
6
   4.8%
Severe problems
0
   0.0%
Extreme problems
0
   0.0%
9.Secondary Outcome
Title Change in Baseline of Headache Impact Test (HIT-6) 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 assess over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact). The change in baseline will be calculated from the average scores.
Time Frame Baseline, Week 1-4, Week 9-12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included
Arm/Group Title 300 mg ALD403
Hide Arm/Group Description:
Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Overall Number of Participants Analyzed 128
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 1-4 Number Analyzed 126 participants
-8.0  (8.06)
Week 9-12 Number Analyzed 124 participants
-7.9  (7.96)
10.Secondary Outcome
Title Change in Most Bothersome Symptom at Week 48
Hide Description The Investigator verbally obtained the most bothersome symptom associated with the participant's migraine during the screening visit. The most bothersome symptom may include nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, or other migraine related symptoms. Participants were asked to rate the improvement in this symptom from screening on a seven-point scale.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all participants who received study drug. Only participants who completed the Week 48 Visit are included
Arm/Group Title 300 mg ALD403
Hide Arm/Group Description:
Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Overall Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
Very Much Improved
40
  35.7%
Much Improved
44
  39.3%
Minimally Improved
17
  15.2%
No Change
11
   9.8%
Minimally Worse
0
   0.0%
Much Worse
0
   0.0%
Very Much Worse
0
   0.0%
11.Secondary Outcome
Title Change From Baseline of Migraine Disability Assessment (MIDAS) Total Score
Hide Description

The MIDAS questionnaire measures the effect headaches have on the participant's daily functioning. MIDAS is composed of five questions that ask about the participant's performance over the past 3 months. The response to each question is provided in number of days which are summed to determine the MIDAS total score and level of disability:

0-5, MIDAS Grade I, little or no disability; 6-10, MIDAS Grade II, mild disability; 11-20, MIDAS Grade III, moderate disability; 21+, MIDAS Grade IV, severe disability;

A higher value represents a worse outcome.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included
Arm/Group Title 300 mg ALD403
Hide Arm/Group Description:
Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Overall Number of Participants Analyzed 123
Mean (Standard Deviation)
Unit of Measure: score on a scale
-36.3  (51.85)
12.Secondary Outcome
Title Development of Anti-ALD403 Antibody by Visit
Hide Description Serum blood samples were taken at visits to test for the development of antibodies to ALD403, or anti-drug antibodies (ADA). Participants who tested positive for anti-ALD403 antibodies at the time of the last study visit were asked to provide up to 2 additional blood samples for immunogenicity testing at approximately 3 month intervals for up to 6 months.
Time Frame Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all participants who received study drug.
Arm/Group Title 300 mg ALD403
Hide Arm/Group Description:
Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Overall Number of Participants Analyzed 128
Measure Type: Count of Participants
Unit of Measure: Participants
Day 0: ADA Results Number Analyzed 128 participants
ADA Positive
0
   0.0%
ADA Negative
128
 100.0%
Week 2 : ADA Results Number Analyzed 127 participants
ADA Positive
1
   0.8%
ADA Negative
126
  99.2%
Week 4 : ADA Results Number Analyzed 126 participants
ADA Positive
0
   0.0%
ADA Negative
126
 100.0%
Week 8 : ADA Results Number Analyzed 125 participants
ADA Positive
7
   5.6%
ADA Negative
118
  94.4%
Week 12 : ADA Results Number Analyzed 123 participants
ADA Positive
11
   8.9%
ADA Negative
112
  91.1%
Week 24 : ADA Results Number Analyzed 120 participants
ADA Positive
21
  17.5%
ADA Negative
99
  82.5%
Week 36 : ADA Results Number Analyzed 118 participants
ADA Positive
9
   7.6%
ADA Negative
109
  92.4%
Week 48 : ADA Results Number Analyzed 113 participants
ADA Positive
6
   5.3%
ADA Negative
107
  94.7%
Week 72 : ADA Results Number Analyzed 101 participants
ADA Positive
4
   4.0%
ADA Negative
97
  96.0%
Week 104 : ADA Results Number Analyzed 96 participants
ADA Positive
0
   0.0%
ADA Negative
96
 100.0%
13.Secondary Outcome
Title Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit
Hide Description Any samples that were positive for anti-ALD403 antibody, there was additional testing to characterize the anti-ALD403 antibody for the potential to neutralize (NAb) ALD403 activity.
Time Frame Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all participants who received study drug.
Arm/Group Title 300 mg ALD403
Hide Arm/Group Description:
Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Overall Number of Participants Analyzed 128
Measure Type: Count of Participants
Unit of Measure: Participants
Day 0: NAb Results Number Analyzed 0 participants
NAb Positive 0
NAb Negative 0
Week 2 : NAb Results Number Analyzed 1 participants
NAb Positive
0
   0.0%
NAb Negative
1
 100.0%
Week 4 : NAb Results Number Analyzed 0 participants
NAb Positive 0
NAb Negative 0
Week 8 : NAb Results Number Analyzed 7 participants
NAb Positive
3
  42.9%
NAb Negative
4
  57.1%
Week 12 : NAb Results Number Analyzed 11 participants
NAb Positive
8
  72.7%
NAb Negative
3
  27.3%
Week 24 : NAb Results Number Analyzed 21 participants
NAb Positive
5
  23.8%
NAb Negative
16
  76.2%
Week 36 : NAb Results Number Analyzed 9 participants
NAb Positive
1
  11.1%
NAb Negative
8
  88.9%
Week 48 : NAb Results Number Analyzed 6 participants
NAb Positive
1
  16.7%
NAb Negative
5
  83.3%
Week 72 : NAb Results Number Analyzed 4 participants
NAb Positive
0
   0.0%
NAb Negative
4
 100.0%
Week 104 : NAb Results Number Analyzed 0 participants
NAb Positive 0
NAb Negative 0
Time Frame Baseline to Week 104 (end of study)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 300 mg ALD403
Hide Arm/Group Description Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
All-Cause Mortality
300 mg ALD403
Affected / at Risk (%)
Total   0/128 (0.00%) 
Hide Serious Adverse Events
300 mg ALD403
Affected / at Risk (%)
Total   5/128 (3.91%) 
Immune system disorders   
Anaphylactic Reaction † 1  1/128 (0.78%) 
Infections and infestations   
Pneumonia † 1  1/128 (0.78%) 
Metabolism and nutrition disorders   
Diabetes Mellitus Inadequate Control † 1  1/128 (0.78%) 
Musculoskeletal and connective tissue disorders   
Osteoarthritis † 1  1/128 (0.78%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Uterine Leiomyoma † 1  1/128 (0.78%) 
Psychiatric disorders   
Conversion Disorder † 1  1/128 (0.78%) 
1
Term from vocabulary, MedDRA (20.1)
†
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
Affected / at Risk (%)
Total   49/128 (38.28%) 
Infections and infestations   
Bronchitis † 1  7/128 (5.47%) 
Influenza † 1  8/128 (6.25%) 
Nasopharyngitis † 1  18/128 (14.06%) 
Sinusitis † 1  10/128 (7.81%) 
Upper respiratory tract infection † 1  10/128 (7.81%) 
Nervous system disorders   
Migraine † 1  7/128 (5.47%) 
1
Term from vocabulary, MedDRA (20.1)
†
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
Layout table for additonal information
Responsible Party: Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02985398    
Other Study ID Numbers: ALD403-CLIN-013
First Submitted: December 5, 2016
First Posted: December 7, 2016
Results First Submitted: March 20, 2020
Results First Posted: April 21, 2020
Last Update Posted: April 21, 2020