Clinical Trial Results:
Interventional, randomized, double-blind, parallel-group, placebo-controlled delayed-start study to evaluate the efficacy and safety of eptinezumab in patients with episodic Cluster Headache
Summary
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EudraCT number |
2020-001969-37 |
Trial protocol |
NO DK DE SE CZ PT FR BE NL FI GR IT |
Global end of trial date |
05 Oct 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Sep 2024
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First version publication date |
29 Sep 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
19386A
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04688775 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
H. Lundbeck A/S
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Sponsor organisation address |
Ottiliavej 9, Valby, Denmark, 2500
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Public contact |
Email contact via H. Lundbeck A/S, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@Lundbeck.com
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Scientific contact |
Email contact via H. Lundbeck A/S, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@Lundbeck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
05 Oct 2023
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Oct 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH).
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Protection of trial subjects |
This trial was conducted in compliance with Good Clinical Practice and in accordance with
the ethical principles described in the Declaration of Helsinki.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Dec 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 4
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Country: Number of subjects enrolled |
Czechia: 29
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Country: Number of subjects enrolled |
Germany: 6
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Country: Number of subjects enrolled |
Denmark: 18
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Country: Number of subjects enrolled |
Spain: 19
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Country: Number of subjects enrolled |
Finland: 6
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Country: Number of subjects enrolled |
France: 17
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Country: Number of subjects enrolled |
United Kingdom: 2
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Country: Number of subjects enrolled |
Georgia: 27
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Country: Number of subjects enrolled |
Greece: 10
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Country: Number of subjects enrolled |
Italy: 48
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Country: Number of subjects enrolled |
Japan: 5
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Country: Number of subjects enrolled |
Netherlands: 1
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Country: Number of subjects enrolled |
Norway: 2
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Country: Number of subjects enrolled |
Portugal: 13
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Country: Number of subjects enrolled |
Russian Federation: 6
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Country: Number of subjects enrolled |
Sweden: 4
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Country: Number of subjects enrolled |
United States: 14
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Worldwide total number of subjects |
231
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EEA total number of subjects |
177
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
223
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From 65 to 84 years |
8
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 231 participants were enrolled in 18 countries. | |||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Placebo-controlled period
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||||||||
Roles blinded |
Investigator, Subject | |||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Eptinezumab | |||||||||||||||||||||||||||||||||
Arm description |
Participants received a single intravenous (IV) infusion of eptinezumab 400 milligrams (mg) in 100 milliliters (mL) 0.9% saline solution. | |||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Eptinezumab
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Investigational medicinal product code |
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Other name |
Vyepti
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Pharmaceutical forms |
Solution for infusion, Solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Eptinezumab was administered per schedule specified in the arm description.
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Arm title
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Placebo | |||||||||||||||||||||||||||||||||
Arm description |
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab. | |||||||||||||||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Placebo was administered per schedule specified in the arm description.
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Period 2
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Period 2 title |
Delayed start period
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Is this the baseline period? |
No | |||||||||||||||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Delayed Start Period: Placebo to Eptinezumab | |||||||||||||||||||||||||||||||||
Arm description |
Participants who received placebo in the placebo-controlled period received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution. | |||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Eptinezumab
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Investigational medicinal product code |
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Other name |
Vyepti
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Pharmaceutical forms |
Solution for infusion, Solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Eptinezumab was administered per schedule specified in the arm description.
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Arm title
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Delayed Start Period: Eptinezumab to Placebo | |||||||||||||||||||||||||||||||||
Arm description |
Participants who received eptinezumab in the placebo-controlled period received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab. | |||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Placebo was administered per schedule specified in the arm description.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo-controlled period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Eptinezumab
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Reporting group description |
Participants received a single intravenous (IV) infusion of eptinezumab 400 milligrams (mg) in 100 milliliters (mL) 0.9% saline solution. | ||
Reporting group title |
Placebo
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Reporting group description |
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab. | ||
Reporting group title |
Delayed Start Period: Placebo to Eptinezumab
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Reporting group description |
Participants who received placebo in the placebo-controlled period received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution. | ||
Reporting group title |
Delayed Start Period: Eptinezumab to Placebo
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Reporting group description |
Participants who received eptinezumab in the placebo-controlled period received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab. |
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End point title |
Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2 | ||||||||||||
End point description |
The participant completed a CH eDiary, daily, and recorded for each day/week whether he/she had any CH attacks. For each CH attack, the start date and time was collected. The participant recorded further daily information regarding CH characteristics and intake of acute medication for CH. CH items were assessed with a yes/no response.
The APRS included all randomized participants.
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End point type |
Primary
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End point timeframe |
Baseline (Week 0), Weeks 1-2
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Statistical analysis title |
Number of Weekly Attacks: Eptinezumab vs. Placebo | ||||||||||||
Comparison groups |
Eptinezumab v Placebo
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Number of subjects included in analysis |
231
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Analysis specification |
Pre-specified
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Analysis type |
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P-value |
= 0.5048 | ||||||||||||
Method |
Mixed Models Repeated Measures | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.7
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-1.3 | ||||||||||||
upper limit |
2.6 |
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End point title |
Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2 | ||||||||||||
End point description |
Abortive medications included the use of triptans or oxygen (O2).
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Weeks 1-2
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No statistical analyses for this end point |
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End point title |
Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2 | |||||||||
End point description |
The APRS included all randomized participants.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Weeks 1-2
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No statistical analyses for this end point |
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End point title |
Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3 | ||||||||||||
End point description |
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Days 1-3
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No statistical analyses for this end point |
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End point title |
Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2 | ||||||||||||
End point description |
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Weeks 1-2
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No statistical analyses for this end point |
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End point title |
Time From First Infusion of IMP to Resolution of Cluster Headache Bout Within the First 4 Weeks | ||||||||||||
End point description |
Presented here is the result of the analysis of time from first infusion of IMP to resolution of cluster headache bout. The hazard ratio estimate is an estimate from the Cox model of time to resolution.
The APRS included all randomized participants.
"99999" = Data Not Reported. Median and 95% CI could not be calculated due to insufficient number of events.
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End point type |
Secondary
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End point timeframe |
From first infusion (Baseline, Day 0) to 4 weeks
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Statistical analysis title |
Time From First Infusion to Resolution | ||||||||||||
Comparison groups |
Eptinezumab v Placebo
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Number of subjects included in analysis |
229
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Analysis specification |
Pre-specified
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Analysis type |
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P-value |
= 0.0772 | ||||||||||||
Method |
Regression, Cox | ||||||||||||
Parameter type |
Hazard ratio (HR) | ||||||||||||
Point estimate |
1.45
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
0.96 | ||||||||||||
upper limit |
2.17 |
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End point title |
Change from Baseline in Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP | ||||||||||||
End point description |
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure.
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End point type |
Secondary
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End point timeframe |
From first infusion in the placebo-controlled period (Baseline, Day 0) to 24-hours after the first infusion in the placebo-controlled period
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No statistical analyses for this end point |
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End point title |
Change From Baseline in the Daily Mean Score on 5-Point Self-Rating Pain Severity Scale, Averaged Over Days 1-3 | ||||||||||||
End point description |
The severity of pain was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (headache pain ratings: 0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating).
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Days 1-3
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No statistical analyses for this end point |
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End point title |
Change From Baseline to Week 1 in the Number of Weekly Attacks | ||||||||||||
End point description |
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Week 1
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No statistical analyses for this end point |
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End point title |
Change From Baseline to Week 2 in the Number of Weekly Attacks | ||||||||||||
End point description |
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Week 2
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No statistical analyses for this end point |
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End point title |
Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 1 | |||||||||
End point description |
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Week 1
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No statistical analyses for this end point |
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End point title |
Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 1 | |||||||||
End point description |
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Week 1
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No statistical analyses for this end point |
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End point title |
Change From Baseline to Week 1 in Weekly Integrated Measure of Frequency and Intensity of Pain | ||||||||||||
End point description |
The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes.
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Week 1
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of pain, Averaged Over Weeks 1-2 | ||||||||||||
End point description |
The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes.
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Weeks 1-2
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No statistical analyses for this end point |
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End point title |
Number of Participants With ≥30% Reduction from Baseline in Number of Weekly Attacks Over Weeks 1-2 | |||||||||
End point description |
The APRS included all randomized participants.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Weeks 1-2
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No statistical analyses for this end point |
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End point title |
Change From Baseline to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain | ||||||||||||
End point description |
The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes.
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Week 2
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No statistical analyses for this end point |
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End point title |
Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4 | ||||||||||||
End point description |
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Weeks 1-4
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-4 | ||||||||||||
End point description |
The weekly integrated measure of frequency and intensity of pain score calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes.
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Weeks 1-4
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|
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No statistical analyses for this end point |
|
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End point title |
Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4 | ||||||||||||||||||||||||
End point description |
The severity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (headache pain ratings: 0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating).
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure and "Number Analyzed" is the number of participants evaluable at the specified time point.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Baseline (Week 0), Weeks 1, 2, 3, and 4
|
||||||||||||||||||||||||
|
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No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Change from Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4 | ||||||||||||||||||
End point description |
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure and "Number Analyzed" is the number of participants evaluable at the specified time point.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Baseline (Week 0), Weeks 3-4
|
||||||||||||||||||
|
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No statistical analyses for this end point |
|
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End point title |
Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4 | |||||||||||||||||||||
End point description |
The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). Lower scores indicate better health status.
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure and "Number Analyzed" is the number of participants evaluable at the specified time point.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Weeks 1, 2, and 4
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
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End point title |
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The SIS is a patient-reported clinical outcome assessment used to assess quality of life resulting from sleep disturbance. The SIS questionnaire includes 35 items belonging to 7 domains to assess sleep impact on: daily activities; emotional well-being; emotional impact; energy/fatigue; social well-being; mental fatigue; and satisfaction with sleep. Each item, for 6 out of the 7 domains, is rated on a 5-point scale ranging from 1 (always or all of the time) to 5 (never or none of the time), whereas satisfaction with sleep is rated on a 5-point scale ranging from 1 (very satisfied) to 5 (very dissatisfied). Each domain yields a score ranging from 0 to 100, which is presented here. A higher score for Daily Activities, Emotional Well-being, Emotional Impact, Energy/Fatigue, Social Well-being, and Mental Fatigue indicates better quality of life. A lower score for Satisfaction with Sleep indicates a higher quality of life.
|
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End point type |
Secondary
|
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End point timeframe |
Baseline (Week 0), Weeks 2 and 4
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Change From Baseline in Euroqol 5-Dimension 5-Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Weeks 2 and 4 | ||||||||||||||||||
End point description |
The EQ-5D-5L VAS is a participant-reported assessment designed to measure the participant's well-being and ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure and "Number Analyzed" is the number of participants evaluable at the specified time point.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Baseline (Week 0), Weeks 2 and 4
|
||||||||||||||||||
|
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No statistical analyses for this end point |
|
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End point title |
Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner | |||||||||||||||||||||||||||
End point description |
Number of participants who visited a family doctor/general practitioner has been reported.
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure at the specified time point.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Week 4
|
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|
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No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
HCRU Score: Number of Visits to a Specialist | ||||||||||||||||||||||||
End point description |
Number of participants who visited a specialist has been reported.
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure at the specified time point.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||||||||||
|
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No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
HCRU Score: Number of Emergency Department Visits Due to Cluster Headache | |||||||||||||||||||||
End point description |
Number of participants who visited an emergency department due to CH was reported.
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure at the specified time point.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Week 4
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
HCRU Score: Number of Hospital Admissions Due to Cluster Headache | |||||||||||||||||||||
End point description |
Number of participants who were admitted to a hospital due to CH was reported.
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure at the specified time point.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Week 4
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
HCRU Score: Number of Overnight Hospital Stays Due to Cluster Headache | |||||||||||||||
End point description |
Number of participants who stayed overnight in a hospital due to CH was reported.
The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome
measure at the specified time point.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Week 4
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4 | ||||||||||||||||||||||||
End point description |
The WPAI:GH2.0 is a patient self-rated clinical outcome assessment designed to provide a quantitative measure of the work productivity and activity impairment due to a health condition. The WPAI:GH2.0 assesses activities over the preceding 7 days and consists of 6 items: 1 item assesses employment (yes/no); 3 items assess the number of hours worked, the number of hours missed from work due to the participant’s condition, or due to other reasons; and 2 visual numerical scales assess how much the participant’s condition affects his/her productivity at work and his/her ability to complete normal daily activities. Each item (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) was calculated into an impairment percentage ranging from 0 to 100%, with higher numbers indicating greater impairment and less productivity (i.e. worse outcomes). Change from baseline for each item is shown here.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Baseline (Week 0), Week 4
|
||||||||||||||||||||||||
|
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No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
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Timeframe for reporting adverse events |
From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
|
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Adverse event reporting additional description |
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.0
|
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Reporting groups
|
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Reporting group title |
Placebo-controlled Period: Eptinezumab
|
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Reporting group description |
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Delayed Start Period: Placebo to Eptinezumab
|
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Reporting group description |
Participants who received placebo in the placebo-controlled period received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Delayed Start Period: Eptinezumab to Placebo
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants who received eptinezumab in the placebo-controlled period received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo-controlled Period: Placebo
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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Frequency threshold for reporting non-serious adverse events: 2% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |