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A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)

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: NCT02945046
Recruitment Status : Terminated (Study was terminated as a result of a pre-specified futility analysis at the interim of 150 participants completing the efficacy analysis of the study.)
First Posted : October 26, 2016
Results First Posted : April 13, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products R&D, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Episodic Cluster Headache
Interventions Drug: Fremanezumab
Drug: Placebo
Enrollment 169
Recruitment Details  
Pre-assignment Details A total of 169 participants were randomized in a 1:1:1 ratio to placebo, fremanezumab 675 milligrams (mg)/placebo/placebo, or fremanezumab 900/225/225 mg groups.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively. Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 milligrams (mg) administered as 3 subcutaneous injections (225 mg/1.5 milliliters [mL]) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively. Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Period Title: Overall Study
Started [1] 59 55 55
Safety Analysis Set [2] 59 55 55
Full Analysis Set [3] 57 53 55
Completed 46 42 40
Not Completed 13 13 15
Reason Not Completed
Adverse Event             1             0             2
Withdrawal by Subject             3             3             3
Protocol Violation             2             3             2
Lost to Follow-up             1             1             0
Lack of Efficacy             1             2             1
Other than specified             5             4             7
[1]
Intent-to-treat (ITT) analysis set: all randomized participants.
[2]
All randomized participants who received at least 1 dose of investigational medicinal product (IMP).
[3]
Received ≥1 dose of IMP; had ≥10 days of postbaseline efficacy assessment on primary endpoint.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg Total
Hide Arm/Group Description Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively. Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively. Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively. Total of all reporting groups
Overall Number of Baseline Participants 59 55 55 169
Hide Baseline Analysis Population Description
ITT analysis set included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 55 participants 55 participants 169 participants
43.1  (10.39) 45.4  (11.23) 43.5  (11.48) 43.9  (11.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 55 participants 55 participants 169 participants
Female
16
  27.1%
17
  30.9%
17
  30.9%
50
  29.6%
Male
43
  72.9%
38
  69.1%
38
  69.1%
119
  70.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 55 participants 55 participants 169 participants
Hispanic or Latino
2
   3.4%
3
   5.5%
5
   9.1%
10
   5.9%
Not Hispanic or Latino
56
  94.9%
52
  94.5%
49
  89.1%
157
  92.9%
Unknown or Not Reported
1
   1.7%
0
   0.0%
1
   1.8%
2
   1.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 55 participants 55 participants 169 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.7%
0
   0.0%
1
   1.8%
2
   1.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   5.1%
0
   0.0%
2
   3.6%
5
   3.0%
White
54
  91.5%
55
 100.0%
51
  92.7%
160
  94.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.7%
0
   0.0%
1
   1.8%
2
   1.2%
Number of CH Attacks   [1] 
Mean (Standard Deviation)
Unit of measure:  CH attacks
Number Analyzed 59 participants 55 participants 55 participants 169 participants
14.8  (10.50) 15.9  (9.18) 14.5  (7.55) 15.1  (9.15)
[1]
Measure Description: A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) at least 1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restlessness or agitation.
1.Primary Outcome
Title Mean Change From Baseline in the Weekly Average Number of Cluster Headache (CH) Attacks During the 4-Week Period After Administration of the First Dose of the IMP
Hide Description A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) at least 1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restlessness or agitation. Least Squares (LS) mean calculated using analysis of covariance (ANCOVA) model with baseline preventive medication use (yes or no), sex, region (United States [US]/Canada or other), and treatment as fixed effects and the baseline number of CH attacks as a covariate. Change from baseline in the overall weekly average number of CH attacks during the 4-week period after administration of the first dose of study drug (based on Week 0 to 4 data) is reported.
Time Frame Baseline (Week 0), up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of IMP and had at least 10 days of postbaseline efficacy assessment in the first 4 weeks on the primary endpoint.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description:
Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Overall Number of Participants Analyzed 57 53 55
Least Squares Mean (Standard Error)
Unit of Measure: CH attacks/week
-5.7  (1.00) -5.8  (1.02) -7.6  (1.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fremanezumab 675 mg/Placebo/Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9093
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-2.72 to 2.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fremanezumab 900/225/225 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1345
Comments Threshold for significance at 0.05 level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-4.49 to 0.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.29
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With a ≥50% Reduction From Baseline in the Weekly Average Number of CH Attacks During the 4-Week Period After the First Dose of the IMP
Hide Description A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) at least 1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restlessness or agitation.
Time Frame Baseline (Week 0), up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of IMP and had at least 10 days of postbaseline efficacy assessment in the first 4 weeks on the primary endpoint.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description:
Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Overall Number of Participants Analyzed 57 53 55
Measure Type: Number
Unit of Measure: percentage of participants
60 55 75
3.Secondary Outcome
Title Mean Change From Baseline in Weekly Average Number of CH Attacks During the 12-Week Period After Administration of the First Dose of the IMP
Hide Description A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) at least 1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restlessness or agitation. LS mean calculated using mixed model for repeated measures (MMRM) with baseline preventive medication use (yes or no), gender, region (US/Canada or other), treatment, month, and month-by-treatment interaction as fixed effects and baseline number of CH attacks as a covariate. Change from baseline in the overall weekly average number of CH attacks during the 12-week period after administration of the first dose of study drug (based on Week 0 to 12 data) is reported.
Time Frame Baseline (Week 0), up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of IMP and had at least 10 days of postbaseline efficacy assessment in the first 4 weeks on the primary endpoint.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description:
Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Overall Number of Participants Analyzed 57 53 55
Least Squares Mean (Standard Error)
Unit of Measure: CH attacks/week
-8.4  (0.66) -8.9  (0.68) -9.6  (0.67)
4.Secondary Outcome
Title Mean Change From Baseline in Weekly Average Number of CH Attacks During the 4-Week Period After Administration of the Third Dose of the IMP
Hide Description A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) at least 1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restlessness or agitation. LS mean calculated using MMRM with baseline preventive medication use (yes or no), gender, region (US/Canada or other), treatment, month, and month-by-treatment interaction as fixed effects and baseline number of CH attacks as a covariate. Change from baseline in the overall weekly average number of CH attacks during the 4-week period after administration of the first dose of study drug (based on Week 8 to 12 data) is reported.
Time Frame Baseline (Week 0), Week 8 up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of IMP and had at least 10 days of postbaseline efficacy assessment in the first 4 weeks on the primary endpoint. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description:
Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Overall Number of Participants Analyzed 46 42 40
Least Squares Mean (Standard Error)
Unit of Measure: CH attacks/week
-10.8  (0.75) -10.8  (0.78) -10.9  (0.78)
5.Secondary Outcome
Title Mean Change From Baseline in the Weekly Average Number of Days With Use of Cluster-Specific Acute Headache Medications (Triptans and Ergot Compounds) During the 12-Week Period After the First Dose of the IMP
Hide Description A maximum of 2 concomitant preventive medications for CH were allowed during the study. Participants must have been on a stable dose and regimen of the concomitant medication for at least 2 weeks before screening and throughout the study. LS mean calculated using ANCOVA model with baseline preventive medication use (yes or no), gender, region (US/Canada or other), and treatment as fixed effects and the baseline number of cluster headache attacks as a covariate. Baseline data and the mean change from baseline in the overall weekly average number of days with the use of cluster-specific acute headache medications (triptans and ergot compounds) during the 12-week period after administration of the first dose of study drug (based on Week 0 to 12 data) is reported.
Time Frame Baseline (Week 0), up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of IMP and had at least 10 days of postbaseline efficacy assessment in the first 4 weeks on the primary endpoint.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description:
Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Overall Number of Participants Analyzed 57 53 55
Least Squares Mean (Standard Error)
Unit of Measure: days of use/week
-1.6  (0.36) -2.4  (0.36) -2.8  (0.36)
6.Secondary Outcome
Title Mean Change From Baseline in the Weekly Average Number of Days Oxygen Was Used to Treat Episodic Cluster Headache (ECH) During the 12-Week Period After the First Dose of the IMP
Hide Description LS mean calculated using ANCOVA model with baseline preventive medication use (yes or no), gender, region (US/Canada or other), and treatment as fixed effects and the baseline number of cluster headache attacks as a covariate. Baseline data and the mean change from baseline in the overall weekly average number of days oxygen was used to treat ECH during the 12-week period after administration of the first dose of IMP (based on Week 0 to 12 data) is reported.
Time Frame Baseline (Week 0), up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of IMP and had at least 10 days of postbaseline efficacy assessment in the first 4 weeks on the primary endpoint.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description:
Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Overall Number of Participants Analyzed 57 53 55
Least Squares Mean (Standard Error)
Unit of Measure: days of use/week
-1.1  (0.30) -1.5  (0.31) -1.0  (0.30)
7.Secondary Outcome
Title Number of Participants Who Perceived Improvement of CH-Associated Pain From Baseline as Measured by the Patient-Perceived Satisfactory Improvement (PPSI) Scale at Weeks 1, 4, 8, and 12
Hide Description The PPSI assessment was developed to measure pain intensity and was adjusted for CH symptoms improvement. Participants marked the level of CH-associated pain and indicated if pain is "1=much worse," "2=moderately worse," "3=slightly worse," "4=unchanged," "5=slightly improved," "6=moderately improved," or "7=much improved" compared with 4 weeks prior. PPSI was defined as the change in pain that corresponds with a minimal rating of "5=slightly improved." Data at Week 1 was recorded on Day 7 in the electronic diary device at home. Week 12 data also included assessment at the early withdrawal visit for participants who discontinued the study early.
Time Frame Baseline, Weeks 1, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of IMP and had at least 10 days of postbaseline efficacy assessment in the first 4 weeks on the primary endpoint.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description:
Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Overall Number of Participants Analyzed 57 53 55
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Much worse
10
  17.5%
14
  26.4%
7
  12.7%
Moderately worse
3
   5.3%
5
   9.4%
8
  14.5%
Slightly worse
3
   5.3%
3
   5.7%
3
   5.5%
Unchanged
37
  64.9%
31
  58.5%
28
  50.9%
Slightly improved
3
   5.3%
0
   0.0%
6
  10.9%
Moderately improved
1
   1.8%
0
   0.0%
1
   1.8%
Much improved
0
   0.0%
0
   0.0%
2
   3.6%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
Week 1 Much worse
2
   3.5%
4
   7.5%
1
   1.8%
Moderately worse
2
   3.5%
2
   3.8%
1
   1.8%
Slightly worse
5
   8.8%
3
   5.7%
2
   3.6%
Unchanged
19
  33.3%
11
  20.8%
9
  16.4%
Slightly improved
11
  19.3%
8
  15.1%
14
  25.5%
Moderately improved
5
   8.8%
3
   5.7%
6
  10.9%
Much improved
6
  10.5%
12
  22.6%
12
  21.8%
Missing
7
  12.3%
10
  18.9%
10
  18.2%
Week 4 Much worse
1
   1.8%
1
   1.9%
2
   3.6%
Moderately worse
3
   5.3%
0
   0.0%
1
   1.8%
Slightly worse
4
   7.0%
2
   3.8%
0
   0.0%
Unchanged
8
  14.0%
11
  20.8%
5
   9.1%
Slightly improved
9
  15.8%
9
  17.0%
8
  14.5%
Moderately improved
5
   8.8%
7
  13.2%
8
  14.5%
Much improved
23
  40.4%
19
  35.8%
27
  49.1%
Missing
4
   7.0%
4
   7.5%
4
   7.3%
Week 8 Much worse
1
   1.8%
1
   1.9%
0
   0.0%
Moderately worse
3
   5.3%
0
   0.0%
1
   1.8%
Slightly worse
0
   0.0%
1
   1.9%
1
   1.8%
Unchanged
13
  22.8%
8
  15.1%
12
  21.8%
Slightly improved
1
   1.8%
6
  11.3%
5
   9.1%
Moderately improved
7
  12.3%
6
  11.3%
7
  12.7%
Much improved
20
  35.1%
20
  37.7%
17
  30.9%
Missing
12
  21.1%
11
  20.8%
12
  21.8%
Week 12 Much worse
3
   5.3%
2
   3.8%
2
   3.6%
Moderately worse
0
   0.0%
0
   0.0%
1
   1.8%
Slightly worse
2
   3.5%
1
   1.9%
0
   0.0%
Unchanged
16
  28.1%
16
  30.2%
16
  29.1%
Slightly improved
5
   8.8%
5
   9.4%
4
   7.3%
Moderately improved
8
  14.0%
7
  13.2%
5
   9.1%
Much improved
17
  29.8%
19
  35.8%
24
  43.6%
Missing
6
  10.5%
3
   5.7%
3
   5.5%
8.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relationship of AE to treatment was determined by the Investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description:
Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Overall Number of Participants Analyzed 59 55 55
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
28
  47.5%
26
  47.3%
28
  50.9%
Treatment-related AEs
8
  13.6%
11
  20.0%
13
  23.6%
Serious AEs
5
   8.5%
0
   0.0%
1
   1.8%
AEs leading to discontinuation
1
   1.7%
0
   0.0%
2
   3.6%
9.Secondary Outcome
Title Number of Participants With Potentially Clinically Significant Laboratory (Serum Chemistry, Hematology, and Urinalysis) Abnormal Results
Hide Description Serum chemistry, hematology, urinalysis laboratory tests with potentially clinically significant abnormal findings included: alanine aminotransferase (ALP), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), lactate dehydrogenase (LDH) each ≥3*upper limit of normal (ULN); blood urea nitrogen (BUN) ≥10.71 millimole (mmol)/L; Bilirubin (Total) ≥34.2 micromole/liter (umol/L); Blood Urea Nitrogen ≥10.71 millimoles (mmol)/L; creatinine ≥177 umol/L; hemoglobin less than or equal to (≤)115 grams (g)/L (males) or ≤95 g/L (females); leukocytes ≥20*10^9/L or ≤3*10^9/L; eosinophils ≥10%; hematocrit <0.37 L/L (males) and <0.32 L/L (females); platelets ≥700*10^9/L or ≤75*10^9/L; haemoglobin, urine glucose, ketones, urine total protein each ≥2 unit (U) increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of the IMP. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description:
Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Overall Number of Participants Analyzed 56 54 54
Measure Type: Count of Participants
Unit of Measure: Participants
With at least 1 serum chemistry abnormality
1
   1.8%
1
   1.9%
0
   0.0%
With at least 1 hematology abnormality
4
   7.1%
1
   1.9%
4
   7.4%
With at least 1 urinalysis abnormality
0
   0.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
Hide Description Coagulation parameters included: prothrombin time (PT) (seconds) and prothrombin international normalized ratio (INR). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Shifts from baseline to endpoint were summarized using participant counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range). Missing PT and prothrombin INR shift data are also presented. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description:
Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Overall Number of Participants Analyzed 59 55 55
Measure Type: Count of Participants
Unit of Measure: Participants
PT Low-Low
0
   0.0%
0
   0.0%
0
   0.0%
Low-Normal
0
   0.0%
0
   0.0%
0
   0.0%
Low-High
0
   0.0%
0
   0.0%
0
   0.0%
Normal-Low
0
   0.0%
0
   0.0%
0
   0.0%
Normal-Normal
47
  79.7%
46
  83.6%
44
  80.0%
Normal-High
2
   3.4%
2
   3.6%
3
   5.5%
High-Low
0
   0.0%
0
   0.0%
0
   0.0%
High-Normal
4
   6.8%
4
   7.3%
4
   7.3%
High-High
1
   1.7%
1
   1.8%
2
   3.6%
Missing
5
   8.5%
2
   3.6%
2
   3.6%
Prothrombin INR Low-Low
0
   0.0%
0
   0.0%
0
   0.0%
Low-Normal
0
   0.0%
0
   0.0%
0
   0.0%
Low-High
0
   0.0%
0
   0.0%
0
   0.0%
Normal-Low
0
   0.0%
0
   0.0%
0
   0.0%
Normal-Normal
48
  81.4%
48
  87.3%
47
  85.5%
Normal-High
2
   3.4%
2
   3.6%
1
   1.8%
High-Low
0
   0.0%
0
   0.0%
0
   0.0%
High-Normal
3
   5.1%
3
   5.5%
3
   5.5%
High-High
1
   1.7%
0
   0.0%
2
   3.6%
Missing
5
   8.5%
2
   3.6%
2
   3.6%
11.Secondary Outcome
Title Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Hide Description Potentially clinically significant abnormal vital signs findings included: pulse rate ≥120 beats per minute (bpm) and increase of 15 bpm; systolic blood pressure ≤90 millimeters of mercury (mmHg) and decrease of 20 mmHg; diastolic blood pressure ≤50 mmHg and decrease of 15 mmHg, or ≥105 mmHg and increase of 15 mmHg. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of the IMP. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description:
Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Overall Number of Participants Analyzed 56 54 54
Measure Type: Count of Participants
Unit of Measure: Participants
3
   5.4%
0
   0.0%
1
   1.9%
12.Secondary Outcome
Title Number of Participants With Shift From Baseline to Endpoint (Last Assessment) in Electrocardiogram (ECG) Parameters
Hide Description ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. Missing ECG shift data are also presented. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description:
Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Overall Number of Participants Analyzed 59 55 55
Measure Type: Count of Participants
Unit of Measure: Participants
Normal / Normal
35
  59.3%
33
  60.0%
23
  41.8%
Normal / Abnormal NCS
6
  10.2%
1
   1.8%
5
   9.1%
Normal / Abnormal CS
0
   0.0%
0
   0.0%
0
   0.0%
Abnormal NCS / Normal
4
   6.8%
9
  16.4%
4
   7.3%
Abnormal NCS / Abnormal NCS
7
  11.9%
9
  16.4%
18
  32.7%
Abnormal NCS / Abnormal CS
0
   0.0%
0
   0.0%
0
   0.0%
Abnormal CS / Normal
0
   0.0%
0
   0.0%
0
   0.0%
Abnormal CS / Abnormal NCS
0
   0.0%
0
   0.0%
0
   0.0%
Abnormal CS / Abnormal CS
0
   0.0%
0
   0.0%
0
   0.0%
Missing
7
  11.9%
3
   5.5%
5
   9.1%
13.Secondary Outcome
Title Number of Participants Who Received Concomitant Medications
Hide Description Concomitant medications included: agents acting on the renin-angiotensin system, all other therapeutic products (for example: homeopathic preparation), allergens, analgesics, anesthetics, anti-parkinson drugs, antianemic preparations, antibacterials for systemic use, antibiotics and chemotherapeutics for dermatological use, antidiarrheals, intestinal antiinflammatory/antiinfective agents, antiemetic, antiepileptics, antifungals for dermatologiocal use, antigout preparations, antihemorrhagics, antihistamines for systemic use, antihypertensives, antiinflammatory and antirheumatic products, antimycotics for systemic use, antipruritics, antipsoriatics, antivirals for systemic use, beta blocking agents, blood substitutes and perfusion solutions, cardiac therapy, corticosteroids, cough and cold preparations, diagnostic radiopharmaceuticals, diuretics, thyroid therapy, urologicals, vaccines, psycoleptics, psycoanaleptics, ophthalmologicals, muscle relaxants, drugs used in diabetes etc.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description:
Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Overall Number of Participants Analyzed 59 55 55
Measure Type: Count of Participants
Unit of Measure: Participants
57
  96.6%
52
  94.5%
52
  94.5%
14.Secondary Outcome
Title Number of Participants With Injection Site Reactions
Hide Description Number of participants who reported treatment-emergent injection site reactions are summarized. Preferred terms from Medical Dictionary for Regulatory Activities (MedDRA) version 18.1 were offered without a threshold applied. Injection site reactions included injection site erythema, induration, pain, haemorrhage, swelling, and pruritus. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description:
Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Overall Number of Participants Analyzed 59 55 55
Measure Type: Count of Participants
Unit of Measure: Participants
Injection site induration
1
   1.7%
3
   5.5%
6
  10.9%
Injection site pain
4
   6.8%
2
   3.6%
6
  10.9%
Injection site erythema
2
   3.4%
0
   0.0%
2
   3.6%
Injection site haemorrhage
0
   0.0%
0
   0.0%
1
   1.8%
Injection site pruritus
1
   1.7%
0
   0.0%
1
   1.8%
Injection site swelling
0
   0.0%
1
   1.8%
0
   0.0%
15.Secondary Outcome
Title Number of Participants With Hypersensitivity/Anaphylaxis Reactions
Hide Description A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description:
Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Overall Number of Participants Analyzed 59 55 55
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
Hide Description eC-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of the IMP.
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description:
Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.
Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
Overall Number of Participants Analyzed 59 55 55
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   1.8%
4
   7.3%
Time Frame Baseline up to Week 12
Adverse Event Reporting Description Safety analysis set included all randomized participants who received at least 1 dose of the IMP.
 
Arm/Group Title Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Hide Arm/Group Description Participants received placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively. Participants received placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 mg administered as 3 subcutaneous injections (225 mg/1.5 mL) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively. Participants received fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.
All-Cause Mortality
Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)      0/55 (0.00%)      0/55 (0.00%)    
Hide Serious Adverse Events
Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/59 (8.47%)      0/55 (0.00%)      1/55 (1.82%)    
Ear and labyrinth disorders       
Vertigo  1  1/59 (1.69%)  1 0/55 (0.00%)  0 0/55 (0.00%)  0
Gastrointestinal disorders       
Duodenitis  1  1/59 (1.69%)  1 0/55 (0.00%)  0 0/55 (0.00%)  0
General disorders       
Chest pain  1  1/59 (1.69%)  2 0/55 (0.00%)  0 0/55 (0.00%)  0
Injury, poisoning and procedural complications       
Lumbar vertebral fracture  1  1/59 (1.69%)  1 0/55 (0.00%)  0 0/55 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer  1  0/59 (0.00%)  0 0/55 (0.00%)  0 1/55 (1.82%)  1
Nervous system disorders       
Cluster headache  1  2/59 (3.39%)  3 0/55 (0.00%)  0 0/55 (0.00%)  0
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Fremanezumab 675 mg/Placebo/Placebo Fremanezumab 900/225/225 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/59 (11.86%)      9/55 (16.36%)      16/55 (29.09%)    
General disorders       
Injection site induration  1  1/59 (1.69%)  1 3/55 (5.45%)  7 6/55 (10.91%)  10
Injection site pain  1  4/59 (6.78%)  6 2/55 (3.64%)  5 6/55 (10.91%)  17
Infections and infestations       
Influenza  1  2/59 (3.39%)  2 0/55 (0.00%)  0 3/55 (5.45%)  3
Nasopharyngitis  1  1/59 (1.69%)  1 4/55 (7.27%)  5 4/55 (7.27%)  4
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Study was terminated as a result of a pre-specified futility analysis at the interim of 150 participants completing the efficacy analysis of the study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 1-888-483-8279
EMail: USMedInfo@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products R&D, Inc. )
ClinicalTrials.gov Identifier: NCT02945046    
Other Study ID Numbers: TV48125-CNS-30056
2016-003278-42 ( EudraCT Number )
First Submitted: October 25, 2016
First Posted: October 26, 2016
Results First Submitted: March 27, 2020
Results First Posted: April 13, 2020
Last Update Posted: July 7, 2020