Not provided
Not provided
Not provided
Not provided
Not provided
Terminated [Study would not complete enrollment target until 2026 with results available in 2027. The information will not be useful at that time.]
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
To evaluate the effect of erenumab compared to placebo on disability in employed subjects with episodic migraine (EM) who have previously failed 1 or more migraine preventive treatments.
Migraine prevention continues to be an area of large, unmet medical need, with existing therapies often having modest efficacy and poor tolerability. Calcitonin gene-related peptide (CGRP) has an important role in the pathophysiology of migraine. Erenumab-aooe is a fully human monoclonal antibody that targets the CGRP receptor, and interrupts its downstream effects. Erenumab has been approved for the preventive treatment of migraine in adults. The present study is a Phase IV trial that will assess the effect of erenumab on disability and work productivity in employed subjects with episodic migraine (EM) who have previously failed 1 or more migraine preventive treatments.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | After subjects complete baseline and are found eligible, they will be enrolled and randomized in a 1:1 ratio to either erenumab or placebo. |
|
| Erenumab | Experimental | After subjects complete baseline and are found eligible, they will be enrolled and randomized in a 1:1 ratio to either erenumab or placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo once every 4 weeks. SC injection. |
| |
| Erenumab |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Monthly Changes From Baseline in Modified MIDAS Total Score Over the 6-month DBTP | The modified MIDAS Questionnaire is a 5-item questionnaire that measures headache-related disability as lost time from paid work or school, housework, and non-work (family, social, and leisure) activities. Participants provided the number of productive days lost or productivity reduced by half or more over the past month due to headache (item score range from 0 to 31). Productive days lost counted in items 1 and 3 were not included for items 2 and 4, respectively. The 5 item scores were summed to calculate the MIDAS total score (range from 0 to 93). The change from baseline was calculated by subtracting the baseline total score from the total score calculated each month. The change from baseline values for Months 1 to 6 were then summed to calculate the sum of monthly changes from baseline (range from -558 to 558). A negative sum of changes from baseline indicated a better outcome. | Baseline and Months 1 to 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean MMD Over Months 4, 5, and 6 of the 6-month DBTP | A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache) or received migraine-specific medication during aura. A qualified migraine headache was defined either as a migraine (≥30 minutes) with or without aura. The change from baseline in monthly migraine days was calculated as the average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase subtract the number of migraine days during the 4-week baseline phase. A negative change from baseline indicates a better outcome. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35235 | United States | ||
| Research Site |
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Eligible participants were randomized in a 1:1 ratio to either erenumab 140 milligrams (mg) or placebo once monthly (QM).
This study was conducted at 13 centers in the United States of America. The study consisted of a 4-week baseline period and a 6-month double-blind treatment period (DBTP).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo QM | Participants randomized to receive placebo QM for 6 months during the DBTP. |
| FG001 | Erenumab 140 mg QM | Participants randomized to receive erenumab 140 mg QM for 6 months during the DBTP. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2020 | May 27, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Erenumab once every 4 weeks. SC injection. |
|
|
| Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP |
| Change From Baseline in Mean Monthly Percent Work Impairment Over Months 4, 5, and 6 of the 6-month DBTP | Percent work impairment was calculated based on questions 2, 4 and 5 of the Work Productivity and Activity Impairment (WPAI) Migraine-Questionnaire and could range from 0% to 100%. The questionnaire was collected weekly. The monthly percent work impairment was equal to the arithmetic mean of the observed weekly percent work impairment over the monthly interval. Higher scores indicate greater impairment. Change from baseline in mean monthly percent work impairment was calculated as the average of monthly percent work impairment over the last 3 months (month 4, 5, and 6) of the 24-week double-blind treatment phase minus the baseline score. A negative change from baseline indicates a better outcome. | Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP |
| Change From Baseline in Mean MFIQ Physical Functioning Domain Score Over Months 4, 5, and 6 of the 6-month DBTP | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning. Participants responded to 5 items on the impact on physical functioning domain using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. The scores were calculated as the sum of the item responses rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden. The MFIQ physical functioning domain score was calculated per month for months 4, 5, and 6 and the mean over this period was calculated. The MFIQ physical functioning domain score during the 4-week baseline period was then subtracted to calculate the change from baseline in mean MFIQ physical functioning domain score over months 4, 5,and 6 of the 6-month DBTP. A negative change from baseline indicates a better outcome. | Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP |
| Change From Baseline in Mean MFIQ Usual Activities Domain Score Over Months 4, 5, and 6 of the 6-month DBTP | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning. Participants responded to 10 items on the impact on usual activities domain using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. The scores were calculated as the sum of the item responses rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden. The MFIQ usual activities domain score was calculated per month for months 4, 5, and 6 and the mean over this period was calculated. The MFIQ usual activities domain score during the 4-week baseline period was then subtracted to calculate the change from baseline in mean MFIQ usual activities domain score over months 4, 5,and 6 of the 6-month DBTP. A negative change from baseline indicates a better outcome. | Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP |
| Change From Baseline in Mean MFIQ Social Functioning Domain Score Over Months 4, 5, and 6 of the 6-month DBTP | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning. Participants responded to 5 items on the impact on social functioning domain using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. The scores were calculated as the sum of the item responses rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden. The MFIQ social functioning domain score was calculated per month for months 4, 5, and 6 and the mean over this period was calculated. The MFIQ social functioning domain score during the 4-week baseline period was then subtracted to calculate the change from baseline in mean MFIQ social functioning domain score over months 4, 5,and 6 of the 6-month DBTP. A negative change from baseline indicates a better outcome. | Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP |
| Huntsville |
| Alabama |
| 35805 |
| United States |
| Research Site | Los Angeles | California | 90094 | United States |
| Research Site | Pasadena | California | 91105 | United States |
| Research Site | Basalt | Colorado | 81621 | United States |
| Research Site | East Hartford | Connecticut | 06118 | United States |
| Research Site | New London | Connecticut | 06320 | United States |
| Research Site | Stamford | Connecticut | 06905 | United States |
| Research Site | Jacksonville | Florida | 32216 | United States |
| Research Site | Orlando | Florida | 32806 | United States |
| Research Site | Chalmette | Louisiana | 70043 | United States |
| Research Site | Hagerstown | Maryland | 21742 | United States |
| Research Site | Worcester | Massachusetts | 01605 | United States |
| Research Site | Ann Arbor | Michigan | 48104 | United States |
| Research Site | Minneapolis | Minnesota | 55402 | United States |
| Research Site | Bolivar | Missouri | 65613 | United States |
| Research Site | City of Saint Peters | Missouri | 63303 | United States |
| Research Site | Springfield | Missouri | 65810 | United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Toms River | New Jersey | 08755 | United States |
| Research Site | Durham | North Carolina | 27713 | United States |
| Research Site | Greensboro | North Carolina | 27405 | United States |
| Research Site | Centerville | Ohio | 45459 | United States |
| Research Site | Philadelphia | Pennsylvania | 19107 | United States |
| Research Site | Nashville | Tennessee | 37203 | United States |
| Research Site | Austin | Texas | 78731 | United States |
| Research Site | Frisco | Texas | 75034 | United States |
| Research Site | Salt Lake City | Utah | 84109 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The respective full analysis set consisted of all participants who were randomized in the study through traditional study sites or decentralized clinical trial sites (DCTS).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo QM | Participants randomized to receive placebo QM for 6 months during the DBTP. |
| BG001 | Erenumab 140 mg QM | Participants randomized to receive erenumab 140 mg QM for 6 months during the DBTP. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Modified Migraine Disability Assessment (MIDAS) Total Score | The modified MIDAS Questionnaire is a 5-item questionnaire that measures headache-related disability as lost time from paid work or school, housework, and non-work (family, social, and leisure) activities. Participants provided the number of productive days lost or productivity reduced by half or more over the past month due to headache (item score range from 0 to 31). Productive days lost counted in items 1 and 3 were not included for items 2 and 4, respectively. The 5 item scores were summed to calculate the MIDAS total score (range from 0 to 93). Higher scores indicated a worse outcome. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||
| Monthly Migraine Days (MMD) | A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache) or received migraine-specific medication during aura. A qualified migraine headache was defined either as a migraine (≥30 minutes) with or without aura. MMD were calculated as the number of migraine days in the 4-week baseline period. | Mean | Standard Deviation | migraine days per month |
| ||||||||||||||
| Monthly Percent Work Impairment | Percent work impairment was calculated based on questions 2, 4 and 5 of the Work Productivity and Activity Impairment (WPAI) Migraine-Questionnaire and could range from 0% to 100%. The questionnaire was collected weekly. The monthly percent work impairment was equal to the arithmetic mean of the observed weekly percent work impairment over the monthly interval (4-week baseline period). Higher scores indicate greater impairment. | Mean | Standard Deviation | percentage of monthly workdays impaired |
| ||||||||||||||
| Migraine Functional Impact Questionnaire (MFIQ) - Impact on Physical Functioning Domain Score | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning. Participants responded to 5 items in the impact on physical functioning domain using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. The scores were calculated as the sum of the item responses rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||
| MFIQ - Impact on Usual Activities Domain Score | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning. Participants responded to 10 items in the impact on usual activities domain using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. The scores were calculated as the sum of the item responses rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||
| MFIQ - Impact on Social Functioning Domain Score | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning. Participants responded to 5 items in the impact on social functioning domain using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. The scores were calculated as the sum of the item responses rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden. | Mean | Standard Deviation | score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sum of Monthly Changes From Baseline in Modified MIDAS Total Score Over the 6-month DBTP | The modified MIDAS Questionnaire is a 5-item questionnaire that measures headache-related disability as lost time from paid work or school, housework, and non-work (family, social, and leisure) activities. Participants provided the number of productive days lost or productivity reduced by half or more over the past month due to headache (item score range from 0 to 31). Productive days lost counted in items 1 and 3 were not included for items 2 and 4, respectively. The 5 item scores were summed to calculate the MIDAS total score (range from 0 to 93). The change from baseline was calculated by subtracting the baseline total score from the total score calculated each month. The change from baseline values for Months 1 to 6 were then summed to calculate the sum of monthly changes from baseline (range from -558 to 558). A negative sum of changes from baseline indicated a better outcome. | The respective efficacy analysis set (EAS) consisted of a subset of participants from traditional study sites or DCTS who received at least 1 dose of investigational product (IP) and had a baseline value and at least 1 post baseline value for the endpoint of interest. Participants were analyzed according to their randomized treatment, regardless of the treatment received. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Months 1 to 6 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean MMD Over Months 4, 5, and 6 of the 6-month DBTP | A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache) or received migraine-specific medication during aura. A qualified migraine headache was defined either as a migraine (≥30 minutes) with or without aura. The change from baseline in monthly migraine days was calculated as the average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase subtract the number of migraine days during the 4-week baseline phase. A negative change from baseline indicates a better outcome. | The respective EAS including only participants with observed MMD data. | Posted | Mean | Standard Deviation | migraine days per month | Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Monthly Percent Work Impairment Over Months 4, 5, and 6 of the 6-month DBTP | Percent work impairment was calculated based on questions 2, 4 and 5 of the Work Productivity and Activity Impairment (WPAI) Migraine-Questionnaire and could range from 0% to 100%. The questionnaire was collected weekly. The monthly percent work impairment was equal to the arithmetic mean of the observed weekly percent work impairment over the monthly interval. Higher scores indicate greater impairment. Change from baseline in mean monthly percent work impairment was calculated as the average of monthly percent work impairment over the last 3 months (month 4, 5, and 6) of the 24-week double-blind treatment phase minus the baseline score. A negative change from baseline indicates a better outcome. | The respective EAS including only participants with observed WPAI data. | Posted | Mean | Standard Deviation | percentage of monthly workdays impaired | Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean MFIQ Physical Functioning Domain Score Over Months 4, 5, and 6 of the 6-month DBTP | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning. Participants responded to 5 items on the impact on physical functioning domain using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. The scores were calculated as the sum of the item responses rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden. The MFIQ physical functioning domain score was calculated per month for months 4, 5, and 6 and the mean over this period was calculated. The MFIQ physical functioning domain score during the 4-week baseline period was then subtracted to calculate the change from baseline in mean MFIQ physical functioning domain score over months 4, 5,and 6 of the 6-month DBTP. A negative change from baseline indicates a better outcome. | The respective EAS including only participants with observed MFIQ data. | Posted | Mean | Standard Deviation | score on a scale | Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean MFIQ Usual Activities Domain Score Over Months 4, 5, and 6 of the 6-month DBTP | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning. Participants responded to 10 items on the impact on usual activities domain using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. The scores were calculated as the sum of the item responses rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden. The MFIQ usual activities domain score was calculated per month for months 4, 5, and 6 and the mean over this period was calculated. The MFIQ usual activities domain score during the 4-week baseline period was then subtracted to calculate the change from baseline in mean MFIQ usual activities domain score over months 4, 5,and 6 of the 6-month DBTP. A negative change from baseline indicates a better outcome. | The respective EAS including only participants with observed MFIQ data. | Posted | Mean | Standard Deviation | score on a scale | Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean MFIQ Social Functioning Domain Score Over Months 4, 5, and 6 of the 6-month DBTP | The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning. Participants responded to 5 items on the impact on social functioning domain using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. The scores were calculated as the sum of the item responses rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden. The MFIQ social functioning domain score was calculated per month for months 4, 5, and 6 and the mean over this period was calculated. The MFIQ social functioning domain score during the 4-week baseline period was then subtracted to calculate the change from baseline in mean MFIQ social functioning domain score over months 4, 5,and 6 of the 6-month DBTP. A negative change from baseline indicates a better outcome. | The respective EAS including only participants with observed MFIQ data. | Posted | Mean | Standard Deviation | score on a scale | Baseline and the last 3 months (months 4, 5, and 6) of the 6-month DBTP |
|
Baseline up to Month 6
The respective safety analysis set consisted of all randomized participants from traditional study sites or DCTS who received at least 1 dose of IP.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo QM | Participants randomized to receive placebo QM for 6 months during the DBTP. | 0 | 15 | 0 | 15 | 7 | 15 |
| EG001 | Erenumab 140 mg QM | Participants randomized to receive erenumab 140 mg QM for 6 months during the DBTP. | 0 | 14 | 0 | 14 | 9 | 14 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 24 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
| |
| Generalised anxiety disorder | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
| |
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
| |
| Polymenorrhoea | Reproductive system and breast disorders | MedDRA 24 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
|
The study was terminated early due to slow enrollment and the impact of COVID-19 on the work productivity study endpoints, beyond normal operational disruptions.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 20, 2020 | May 27, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000605816 | erenumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|