Clinical Trial Results:
A Single-Dose, Open-Label Study to Characterize the Pharmacokinetics, Safety and Tolerability of Subcutaneous Administration of Fremanezumab in Pediatric Migraine Patients (6 to 11 Years of Age Inclusive)
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Summary
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EudraCT number |
2018-000734-35 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
07 Jun 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Dec 2019
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First version publication date |
19 Dec 2019
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Other versions |
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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 |
TV48125-CNS-10141
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Teva Branded Pharmaceutical Products, R&D Inc.
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Sponsor organisation address |
41 Moores Road, Frazer, United States, 19355
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Public contact |
Director, Clinical Research, Teva Branded Pharmaceutical Products, R&D Inc, 001 8884838279, info.eraclinical@teva.de
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Scientific contact |
Director, Clinical Research, Teva Branded Pharmaceutical Products, R&D Inc., 001 8884838279, info.eraclinical@teva.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-001877-PIP01-15 | ||
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? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Jul 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
07 Jun 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
07 Jun 2019
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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 primary objective of this study was to characterize the pharmacokinetic profile of fremanezumab following administration of a single subcutaneous (SC) dose in pediatric participants with migraine (6 to 11 years of age inclusive).
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Protection of trial subjects |
This study was conducted in full accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Consolidated Guideline (E6) and any applicable national and local laws and regulations (for example; Code of Federal Regulations Title 21, Parts 11, 50, 54, 56, 312, and 314; European Union (EU) Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of GCP in the conduct of clinical studies on medicinal products for human use).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Jun 2018
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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 |
United States: 15
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Worldwide total number of subjects |
15
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EEA total number of subjects |
0
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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) |
15
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
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Pre-assignment
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Screening details |
A total of 17 pediatric participants with migraine were screened for enrollment into this study. Of the 17 participants screened, 15 participants who met entry criteria were enrolled into the study. | ||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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Fremanezumab | ||||||
Arm description |
Participants received a single 75 milligrams (mg) dose of fremanezumab administered SC in the abdomen on Day 1. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Fremanezumab
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Investigational medicinal product code |
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Other name |
AJOVY
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Fremanezumab was administered per dose and schedule specified in the arm description.
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Baseline characteristics reporting groups
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Reporting group title |
Fremanezumab
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Reporting group description |
Participants received a single 75 milligrams (mg) dose of fremanezumab administered SC in the abdomen on Day 1. | ||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Fremanezumab
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Reporting group description |
Participants received a single 75 milligrams (mg) dose of fremanezumab administered SC in the abdomen on Day 1. | ||
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End point title |
Maximum Observed Plasma Drug Concentration (Cmax) [1] | ||||||||
End point description |
Observed peak plasma concentration was obtained directly from the experimental data without interpolation. Pharmacokinetic (PK) analysis set included all participants who received fremanezumab and had sufficient data to calculate at least 1 PK parameter for fremanezumab and participants who had no significant leakage at the injection site, other events, or deviations that could affect the calculation of PK parameters.
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End point type |
Primary
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End point timeframe |
Day 1 (pre-dose), Day 2 (24 hours [hrs] post-dose), Day 11 (240 hrs post-dose), Day 29 (672 hrs post-dose), Day 85 (2016 hrs post-dose), and Day 113 (2688 hrs post-dose)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: PK analyses were descriptive in nature. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Study Drug Concentration (AUC0-t) [2] | ||||||||
End point description |
AUC0-t was calculated by linear trapezoidal summation. PK analysis set included all participants who received fremanezumab and had sufficient data to calculate at least 1 PK parameter for fremanezumab and participants who had no significant leakage at the injection site, other events, or deviations that could affect the calculation of PK parameters.
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End point type |
Primary
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End point timeframe |
Day 1 (pre-dose), Day 2 (24 hrs post-dose), Day 11 (240 hrs post-dose), Day 29 (672 hrs post-dose), Day 85 (2016 hrs post-dose), and Day 113 (2688 hrs post-dose)
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: PK analyses were descriptive in nature. |
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| No statistical analyses for this end point | |||||||||
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End point title |
AUC From Time 0 to 28 Days After Study Drug Administration (AUC0-28d) [3] | ||||||||
End point description |
AUC0-28d was calculated by linear trapezoidal summation. PK analysis set included all participants who received fremanezumab and had sufficient data to calculate at least 1 PK parameter for fremanezumab and participants who had no significant leakage at the injection site, other events, or deviations that could affect the calculation of PK parameters.
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End point type |
Primary
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End point timeframe |
Day 1 (pre-dose), Day 2 (24 hrs post-dose), Day 11 (240 hrs post-dose), Day 29 (672 hrs post-dose), Day 85 (2016 hrs post-dose), and Day 113 (2688 hrs post-dose)
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: PK analyses were descriptive in nature. |
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| No statistical analyses for this end point | |||||||||
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End point title |
AUC From Time 0 to 84 Days After Study Drug Administration (AUC0-84d) [4] | ||||||||
End point description |
AUC084d was calculated by linear trapezoidal summation. PK analysis set included all participants who received fremanezumab and had sufficient data to calculate at least 1 PK parameter for fremanezumab and participants who had no significant leakage at the injection site, other events, or deviations that could affect the calculation of PK parameters.
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End point type |
Primary
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End point timeframe |
Day 1 (pre-dose), Day 2 (24 hrs post-dose), Day 11 (240 hrs post-dose), Day 29 (672 hrs post-dose), Day 85 (2016 hrs post-dose), and Day 113 (2688 hrs post-dose)
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: PK analyses were descriptive in nature. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to Reach Cmax (Tmax) [5] | ||||||||
End point description |
Time corresponding to Cmax was obtained directly from the experimental data. PK analysis set included all participants who received fremanezumab and had sufficient data to calculate at least 1 PK parameter for fremanezumab and participants who had no significant leakage at the injection site, other events, or deviations that could affect the calculation of PK parameters.
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End point type |
Primary
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End point timeframe |
Day 1 (pre-dose), Day 2 (24 hrs post-dose), Day 11 (240 hrs post-dose), Day 29 (672 hrs post-dose), Day 85 (2016 hrs post-dose), and Day 113 (2688 hrs post-dose)
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: PK analyses were descriptive in nature. |
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| No statistical analyses for this end point | |||||||||
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End point title |
AUC From Time 0 to Infinity (AUC0-∞) [6] | ||||||||
End point description |
AUC0-∞ was calculated as AUC0-t + the area extrapolated from the time of the last quantifiable concentration to infinity (Clast/λz). PK analysis set included all participants who received fremanezumab and had sufficient data to calculate at least 1 PK parameter for fremanezumab and participants who had no significant leakage at the injection site, other events, or deviations that could affect the calculation of PK parameters.
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End point type |
Primary
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End point timeframe |
Day 1 (pre-dose), Day 2 (24 hrs post-dose), Day 11 (240 hrs post-dose), Day 29 (672 hrs post-dose), Day 85 (2016 hrs post-dose), and Day 113 (2688 hrs post-dose)
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: PK analyses were descriptive in nature. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage Extrapolated AUC (%AUCext) [7] | ||||||||
End point description |
%AUCext was calculated as: ([AUC0-∞ –AUC0-t]/AUC0-∞) * 100. PK analysis set included all participants who received fremanezumab and had sufficient data to calculate at least 1 PK parameter for fremanezumab and participants who had no significant leakage at the injection site, other events, or deviations that could affect the calculation of PK parameters.
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End point type |
Primary
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End point timeframe |
Day 1 (pre-dose), Day 2 (24 hrs post-dose), Day 11 (240 hrs post-dose), Day 29 (672 hrs post-dose), Day 85 (2016 hrs post-dose), and Day 113 (2688 hrs post-dose)
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: PK analyses were descriptive in nature. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Apparent Plasma Terminal Elimination Rate Constant (λz) [8] | ||||||||
End point description |
λz was calculated by linear regression of the terminal semi-log portion of the concentration-time curve. PK analysis set included all participants who received fremanezumab and had sufficient data to calculate at least 1 PK parameter for fremanezumab and participants who had no significant leakage at the injection site, other events, or deviations that could affect the calculation of PK parameters.
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End point type |
Primary
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End point timeframe |
Day 1 (pre-dose), Day 2 (24 hrs post-dose), Day 11 (240 hrs post-dose), Day 29 (672 hrs post-dose), Day 85 (2016 hrs post-dose), and Day 113 (2688 hrs post-dose)
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| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: PK analyses were descriptive in nature. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Apparent Terminal Elimination Half-Life (t1/2) [9] | ||||||||
End point description |
t1/2 was calculated as: ln(2)/λz. PK analysis set included all participants who received fremanezumab and had sufficient data to calculate at least 1 PK parameter for fremanezumab and participants who had no significant leakage at the injection site, other events, or deviations that could affect the calculation of PK parameters.
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End point type |
Primary
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End point timeframe |
Day 1 (pre-dose), Day 2 (24 hrs post-dose), Day 11 (240 hrs post-dose), Day 29 (672 hrs post-dose), Day 85 (2016 hrs post-dose), and Day 113 (2688 hrs post-dose)
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| Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: PK analyses were descriptive in nature. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Apparent Volume of Distribution (Vz/F) [10] | ||||||||
End point description |
Apparent volume of distribution during the terminal phase was calculated as: Vz/F=Dose/λz*AUCinf. PK analysis set included all participants who received fremanezumab and had sufficient data to calculate at least 1 PK parameter for fremanezumab and participants who had no significant leakage at the injection site, other events, or deviations that could affect the calculation of PK parameters.
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End point type |
Primary
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End point timeframe |
Day 1 (pre-dose), Day 2 (24 hrs post-dose), Day 11 (240 hrs post-dose), Day 29 (672 hrs post-dose), Day 85 (2016 hrs post-dose), and Day 113 (2688 hrs post-dose)
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| Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: PK analyses were descriptive in nature. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Apparent Clearance (CL/F) [11] | ||||||||
End point description |
CL/F was calculated as: Dose/AUC0-∞. PK analysis set included all participants who received fremanezumab and had sufficient data to calculate at least 1 PK parameter for fremanezumab and participants who had no significant leakage at the injection site, other events, or deviations that could affect the calculation of PK parameters.
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End point type |
Primary
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End point timeframe |
Day 1 (pre-dose), Day 2 (24 hrs post-dose), Day 11 (240 hrs post-dose), Day 29 (672 hrs post-dose), Day 85 (2016 hrs post-dose), and Day 113 (2688 hrs post-dose)
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| Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: PK analyses were descriptive in nature. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Participants With Adverse Events (AEs) | ||||||
End point description |
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE was defined as inability to carry out usual activities. Treatment-related AEs were defined as AEs with possible, probable, definite, or missing relationship to study drug. Serious AEs were defined as death, a life-threatening AE, 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 participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Safety analysis set included all participants who received fremanezumab.
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End point type |
Secondary
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End point timeframe |
Baseline up to end of study (Week 17)
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| No statistical analyses for this end point | |||||||
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End point title |
Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values | ||||||
End point description |
Criteria for potentially clinically significant abnormal vital signs values included: pulse: greater than (>)130 millimeters of mercury (mmHg) and less than (<)60 mmHg (in participants of age greater than or equal to [≥] 6 to less than or equal to [≤] 8 years), >110 mmHg and <60 mmHg (in participants of age ≥9 to <12 years), and change of ≥20 mmHg; systolic blood pressure: >120 mmHg and <80 mmHg (in participants of age ≥6 to ≤8 years), >130 mmHg and <80 mmHg (in participants of age ≥9 to <12 years), and change of ≥20 mmHg; diastolic blood pressure: >80 mmHg and <50 mmHg (in participants of age ≥6 to <12 years), and and change of ≥15 mmHg; and body temperature >38.2 degrees Celsius and <35.5 degrees celsius and change of ≥1.1 degrees celsius. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Safety analysis set included all participants who received fremanezumab.
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End point type |
Secondary
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End point timeframe |
Baseline up to end of study (Week 17)
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| No statistical analyses for this end point | |||||||
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End point title |
Number of Participants With Potentially Clinically Significant Abnormal Electrocardiogram (ECG) Values | ||||||
End point description |
Criteria for potentially clinically significant abnormal ECG values included: heart rate: <60 beats/min and >100 beats/min (in participants of age ≥6 to <12 years); PR interval: <90 millisecond (msec) and >170 msec (in participants of age ≥6 to <12 years); QRS interval: <40 msec and >80 msec (in participants of age ≥6 to ≤7 years), <40 msec and >90 msec (in participants of age ≥8 to <12 years); QT interval: <268 msec and >356 msec (in participants of age ≥6 to ≤7 years), <297 msec and >397 msec (in participants of age ≥8 to <12 years); and RR interval <600 msec and >1000 msec (in participants of age ≥6 to <12 years). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Safety analysis set included all participants who received fremanezumab.
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End point type |
Secondary
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End point timeframe |
Baseline up to end of study (Week 17)
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| No statistical analyses for this end point | |||||||
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End point title |
Number of Participants With Potentially Clinically Significant Abnormal Physical Examination Findings | ||||||
End point description |
Physical examination included assessments of the lungs, cardiovascular system, abdomen, and any system or organ that was of interest and/or indicated by symptoms. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Safety analysis set included all participants who received fremanezumab.
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End point type |
Secondary
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End point timeframe |
Baseline up to end of study (Week 17)
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| No statistical analyses for this end point | |||||||
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End point title |
Number of Participants With Potentially Clinically Significant Abnormal Clinical Laboratory Values | ||||||||||||
End point description |
Criteria for clinically significant abnormal clinical laboratory values: serum chemistry (albumin: ≤0.9*lower limit of normal[LLN];alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma-glutamyl transpeptidase, lactate dehydrogenase: ≥3*upper limit of normal[ULN]; international normalized ratio: ≥1.5*ULN; creatine phosphokinase: ≥3.1*ULN; blood urea nitrogen: ≥10.71 millimoles/liter[mmol/L]; creatinine: ≥2*ULN; uric acid: ≥625 micromoles/L[µmol/L] [men], ≥506 µmol/L[women]; bilirubin: ≥34.2 µmol/L), hematology (hematocrit: <0.37 L/L[men], <0.32 L/L[women]; haemoglobin[Hb]: ≤115 grams/L [g/L] [men], ≤95 g/L[women]; leukocytes: ≤3*10^9/L, ≥20*10^9/L; eosinophils: ≥10%; absolute neutrophil counts: ≤1*10^9/L; platelets: ≤75*10^9/L, ≥700*10^9/L), and urinalysis (Hb,glucose,ketones,total proteins: ≥2 unit increase from baseline). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Safety analysis set.
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End point type |
Secondary
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End point timeframe |
Baseline up to end of study (Week 17)
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Participants Who Received Concomitant Medications | ||||||
End point description |
Concomitant medications included all medications taken during study participation. Concomitant medications included: analgesics; antiemetics and antinauseants; antihistamines for systemic use; antiinflammatory and antirheumatic products; antipruritics including antihistamines, anesthetics, etc.; drugs for obstructive airway diseases; psychoanaleptics; psycholeptics; and vitamins. Safety analysis set included all participants who received fremanezumab.
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End point type |
Secondary
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End point timeframe |
Baseline up to end of study (Week 17)
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| No statistical analyses for this end point | |||||||
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End point title |
Number of Participants who Failed to Complete the Study Due to any Reason and Due to AEs | ||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Baseline up to end of study (Week 17)
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| No statistical analyses for this end point | |||||||||||
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End point title |
Number of Participants With Injection Site Reactions and Pain | ||||||||||||||
End point description |
Injection site reactions included erythema, induration, and ecchymosis. Injection site erythema, injection site ecchymosis, and injection site induration were considered only if they reached a diameter of at least 5 millimeters (mm). Induration was assessed by careful superficial palpation, avoiding pressuring or squeezing the injection site. Safety analysis set included all participants who received fremanezumab.
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End point type |
Secondary
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End point timeframe |
Day 1 (20 minutes and 1, 2, and 4 hrs post-dose) and on Day 2 (24 hrs after study drug administration)
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| No statistical analyses for this end point | |||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Baseline up to end of study (Week 17)
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Adverse event reporting additional description |
Safety analysis set included all participants who received fremanezumab.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21.0
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Reporting groups
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Reporting group title |
Fremanezumab
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Reporting group description |
Participants received a single 75 mg dose of fremanezumab administered SC in the abdomen on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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27 Sep 2018 |
The following major procedural changes (not all-inclusive) were made to the protocol:
- Shortened the screening period which allowed the use of the screening visit procedures to determine initial eligibility for the study; - Changed the general study design to provide participants the option to remain overnight at the investigational center for 2 nights (Day −1 to Day 2) so as to facilitate the conduct of multiple intensive and time sensitive study procedures; - Changes to the visit, week, or day due to the new timing of procedures and assessments; - Removed cotinine testing at screening or check-in for exclusion criteria; -
Changed where the clinical laboratory test will be performed from site local laboratory to the central laboratory; - Changed the storage temperature range of the plasma samples. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
