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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003594-26 | EudraCT Number |
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The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of erenumab after multiple subcutaneous (SC) doses in healthy adults and migraine patients, as well as to characterize the effect of erenumab on the capsaicin induced increase in dermal blood flow after multiple SC doses in healthy adults and migraine patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erenumab | Experimental | Healthy participants and participants with migraine received subcutaneous doses of erenumab on days 1, 29 and 57. |
|
| Placebo | Placebo Comparator | Healthy participants and participants with migraine received subcutaneous doses of placebo on days 1, 29 and 57. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erenumab | Drug | Administered by subcutaneous injection once a month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events. Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:
| From first dose of study drug until a maximum of 168 days after last dose (225 days) |
| Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a measure of suicidal ideation and behavior. Ideation includes a wish to be dead or nonspecific thoughts about wanting to end life. Suicidal behavior includes actual attempts, interrupted or aborted attempts, and any preparatory acts. | From first dose of study drug until a maximum of 168 days after last dose (225 days) |
| Number of Participants Who Developed Anti-erenumab Antibodies | Participants who had a negative or no result at baseline and were antibody positive postbaseline. Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies. | From first dose of study drug until a maximum of 168 days after last dose (225 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of Erenumab | Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA). | Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225) |
| Time to Maximum Observed Concentration (Tmax) of Erenumab |
Not provided
Inclusion Criteria:
Healthy male and female subjects, as well as male or female subjects with migraines between 18 and 55 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician;
Exclusion Criteria:
- History or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28736918 | Background | de Hoon J, Van Hecken A, Vandermeulen C, Yan L, Smith B, Chen JS, Bautista E, Hamilton L, Waksman J, Vu T, Vargas G. Phase I, Randomized, Double-blind, Placebo-controlled, Single-dose, and Multiple-dose Studies of Erenumab in Healthy Subjects and Patients With Migraine. Clin Pharmacol Ther. 2018 May;103(5):815-825. doi: 10.1002/cpt.799. Epub 2017 Oct 24. | |
| 31852816 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Healthy participants were randomized to 1 of 4 cohorts and migraine patients were randomized to 1 of 2 cohorts. Within each cohort participants were assigned to erenumab or placebo in a 3:1 ratio.
This study enrolled healthy participants (Part A) and participants with onset of migraines before the age of 50 years, with or without aura for at least 6 months and 3 migraine attacks per month in the last 3 months (Part B). The study was conducted at a single center in Belgium.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy: Placebo | Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57. |
| FG001 | Healthy: Erenumab 21 mg | Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57. |
| FG002 | Healthy: Erenumab 70 mg | Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57. |
| FG003 | Healthy: Erenumab 140 mg | Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57. |
| FG004 | Healthy: Erenumab 280/210 mg | Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57. |
| FG005 | Migraine: Placebo | Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57. |
| FG006 | Migraine: Erenumab 21 mg | Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57. |
| FG007 | Migraine: Erenumab 140 mg | Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy: Placebo | Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57. |
| BG001 | Healthy: Erenumab 21 mg | Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data are reported separately for each part of the study. |
| 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 | Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events. Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:
| All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From first dose of study drug until a maximum of 168 days after last dose (225 days) |
|
From first dose of study drug until a maximum of 168 days after last dose (225 days).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy: Placebo | Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000605816 | erenumab |
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| Placebo | Drug | Administered by subcutaneous injection once a month |
|
Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA). |
| Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225) |
| Area Under the Serum Concentration-Time Curve From 0 to 28 Days (AUC0-28day) | Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA). | Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225) |
| Area Under the Serum Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) | Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA). | Day 57 (assessed from predose to day 225)) |
| Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow | Inhibition of capsaicin-induced dermal blood flow (DBF) by erenumab was used to measure calcitonin gene-related peptide (CGRP) receptor antagonism. Capsaicin was applied at 2 sites on the volar surface of the participants' left or right forearms and a control mixture was applied to 1 site on the volar surface of either the participants' left or right forearm. Dermal blood flow was assessed by laser Doppler perfusion imaging and was done immediately before ('baseline') and 0.5 hours post-capsaicin on the surface of these 3 sites. Data reported are the least square geometric mean ratios for the post-capsaicin dermal blood flow to pre-capsaicin dermal blood flow. According to the protocol, not all cohorts had dermal blood flow measurements at all time points. | Baseline, Days 8, 57, 85, 113, 169 and 197 |
| Kudrow D, Pascual J, Winner PK, Dodick DW, Tepper SJ, Reuter U, Hong F, Klatt J, Zhang F, Cheng S, Picard H, Eisele O, Wang J, Latham JN, Mikol DD. Vascular safety of erenumab for migraine prevention. Neurology. 2020 Feb 4;94(5):e497-e510. doi: 10.1212/WNL.0000000000008743. Epub 2019 Dec 18. |
| BG002 | Healthy: Erenumab 70 mg | Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57. |
| BG003 | Healthy: Erenumab 140 mg | Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57. |
| BG004 | Healthy: Erenumab 280/210 mg | Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57. |
| BG005 | Migraine: Placebo | Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57. |
| BG006 | Migraine: Erenumab 21 mg | Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57. |
| BG007 | Migraine: Erenumab 140 mg | Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57. |
| BG008 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Healthy: Placebo | Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57. |
| OG001 | Healthy: Erenumab 21 mg | Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57. |
| OG002 | Healthy: Erenumab 70 mg | Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57. |
| OG003 | Healthy: Erenumab 140 mg | Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57. |
| OG004 | Healthy: Erenumab 280/210 mg | Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57. |
| OG005 | Migraine: Placebo | Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57. |
| OG006 | Migraine: Erenumab 21 mg | Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57. |
| OG007 | Migraine: Erenumab 140 mg | Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57. |
|
|
| Primary | Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a measure of suicidal ideation and behavior. Ideation includes a wish to be dead or nonspecific thoughts about wanting to end life. Suicidal behavior includes actual attempts, interrupted or aborted attempts, and any preparatory acts. | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From first dose of study drug until a maximum of 168 days after last dose (225 days) |
|
|
|
| Primary | Number of Participants Who Developed Anti-erenumab Antibodies | Participants who had a negative or no result at baseline and were antibody positive postbaseline. Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies. | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From first dose of study drug until a maximum of 168 days after last dose (225 days) |
|
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) of Erenumab | Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA). | All participants for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point. | Posted | Mean | Standard Deviation | μg/mL | Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225) |
|
|
|
| Secondary | Time to Maximum Observed Concentration (Tmax) of Erenumab | Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA). | All participants for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point. | Posted | Median | Full Range | days | Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225) |
|
|
|
| Secondary | Area Under the Serum Concentration-Time Curve From 0 to 28 Days (AUC0-28day) | Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA). | All participants for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point. | Posted | Mean | Standard Deviation | day*μg/mL | Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225) |
|
|
|
| Secondary | Area Under the Serum Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) | Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA). | All participants who received erenumab and for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point. | Posted | Mean | Standard Deviation | day*μg/mL | Day 57 (assessed from predose to day 225)) |
|
|
|
| Secondary | Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow | Inhibition of capsaicin-induced dermal blood flow (DBF) by erenumab was used to measure calcitonin gene-related peptide (CGRP) receptor antagonism. Capsaicin was applied at 2 sites on the volar surface of the participants' left or right forearms and a control mixture was applied to 1 site on the volar surface of either the participants' left or right forearm. Dermal blood flow was assessed by laser Doppler perfusion imaging and was done immediately before ('baseline') and 0.5 hours post-capsaicin on the surface of these 3 sites. Data reported are the least square geometric mean ratios for the post-capsaicin dermal blood flow to pre-capsaicin dermal blood flow. According to the protocol, not all cohorts had dermal blood flow measurements at all time points. | All participants for whom at least 1 postdose capsaicin response measure was recorded. Measurement and analysis of dermal blood flow were not performed in the 280/210 cohort. | Posted | Geometric Least Squares Mean | Standard Error | ratio | Baseline, Days 8, 57, 85, 113, 169 and 197 |
|
|
|
|
| 0 |
| 8 |
| 5 |
| 8 |
| EG001 | Healthy: Erenumab 21 mg | Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57. | 0 | 6 | 6 | 6 |
| EG002 | Healthy: Erenumab 70 mg | Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57. | 1 | 6 | 6 | 6 |
| EG003 | Healthy: Erenumab 140 mg | Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57. | 0 | 6 | 6 | 6 |
| EG004 | Healthy: Erenumab 280/210 mg | Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57. | 0 | 6 | 4 | 6 |
| EG005 | Migraine: Placebo | Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57. | 0 | 4 | 4 | 4 |
| EG006 | Migraine: Erenumab 21 mg | Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57. | 0 | 6 | 6 | 6 |
| EG007 | Migraine: Erenumab 140 mg | Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57. | 1 | 6 | 6 | 6 |
| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Tongue discolouration | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood immunoglobulin E increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
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.
| D009422 | Nervous System Diseases |
|
| Male |
|
| Suicidal Behavior |
|
| Neutralizing antibodies |
|
|
| Day 57 |
|
|
|
| Day 57 |
|
|
|
| Day 57 |
|
|
|
| Day 8 |
|
|
| Day 57 |
|
|
| Day 85 |
|
|
| Day 113 |
|
|
| Day 169 |
|
|
| Day 197 |
|
|
| Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | < 0.001 | LS Geometric Mean Ratio | -71.16 | 2-Sided | 95 | -82.67 | -52.00 | Superiority |
| Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | < 0.001 | LS Geometric Mean Ratio | -79.52 | 2-Sided | 95 | -88.29 | -64.17 | Superiority |
| Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | < 0.001 | LS Geometric Mean Ratio | -72.34 | 2-Sided | 95 | -83.32 | -54.13 | Superiority |
| Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | < 0.001 | LS Geometric Mean Ratio | -73.03 | 2-Sided | 95 | -83.79 | -55.11 | Superiority |
| Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | < 0.001 | LS Geometric Mean Ratio | -71.88 | 2-Sided | 95 | -83.93 | -50.82 | Superiority |
| Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | < 0.001 | LS Geometric Mean Ratio | -68.51 | 2-Sided | 95 | -81.01 | -47.78 | Superiority |
| Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | < 0.001 | LS Geometric Mean Ratio | -81.06 | 2-Sided | 95 | -88.62 | -68.49 | Superiority |
| Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | < 0.001 | LS Geometric Mean Ratio | -79.04 | 2-Sided | 95 | -88.02 | -63.34 | Superiority |
| Day 113: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | 0.25 | LS Geometric Mean Ratio | -32.70 | 2-Sided | 95 | -65.71 | 32.10 | Superiority |
| Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | 0.90 | LS Geometric Mean Ratio | 3.44 | 2-Sided | 95 | -40.78 | 80.66 | Superiority |
| Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | 0.091 | LS Geometric Mean Ratio | -40.53 | 2-Sided | 95 | -67.50 | 8.82 | Superiority |
| Day 197: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | 0.73 | LS Geometric Mean Ratio | 13.33 | 2-Sided | 95 | -44.39 | 130.94 | Superiority |
| Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | 0.001 | LS Geometric Mean Ratio | -80.02 | 2-Sided | 95 | -91.53 | -52.87 | Superiority |
| Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | < 0.001 | LS Geometric Mean Ratio | -87.60 | 2-Sided | 95 | -94.53 | -71.88 | Superiority |
| Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | 0.001 | LS Geometric Mean Rratio | -79.81 | 2-Sided | 95 | -91.44 | -52.37 | Superiority |
| Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | < 0.001 | LS Geometric Mean Ratio | -83.66 | 2-Sided | 95 | -92.79 | -62.95 | Superiority |
| Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | < 0.001 | LS Geometric Mean Ratio | -81.97 | 2-Sided | 95 | -92.35 | -57.46 | Superiority |
| Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | < 0.001 | LS Geometric Mean Ratio | -84.39 | 2-Sided | 95 | -93.12 | -64.60 | Superiority |
| Day 113: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | 0.47 | LS Geometric Mean Ratio | 43.10 | 2-Sided | 95 | -47.06 | 286.83 | Superiority |
| Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | 0.020 | LS Geometric Mean Ratio | -68.58 | 2-Sided | 95 | -88.02 | -17.63 | Superiority |
| Day 197: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 . | Repeated Measures ANCOVA | 0.11 | LS Geometric Mean Ratio | -54.32 | 2-Sided | 95 | -82.58 | 19.75 | Superiority |