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The purpose of this study was to evaluate the efficacy and safety of erenumab in patients with chronic migraine in Asian population.
This study used a single-cohort, 2-treatment arms, randomized (1:1 (70 mg:placebo)), double-blind study design in adult subjects with chronic migraine. A screening period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline period to assess diary compliance and headache frequency.
Eligible patients were then randomized to either erenumab 70 mg or placebo for 12 weeks, followed by an open-label treatment period to last until end of PTA determined by the product launch in the country or the country's decision not to launch. A safety follow-up visit occurred 12 weeks after the last treatment for subjects who discontinue the double-blind treatment or who completed the double-blind treatment period without continuing in the open-label treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erenumab | Experimental | Administered by pre-filled syringe |
|
| Placebo | Placebo Comparator | Administered by pre-filled syringe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erenumab | Biological | Administered by pre-filled syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period | A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥4 continuous hours, and meeting at least one of the following criteria:
| baseline (4 weeks period prior to start of study drug), week 9 to 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Migraine-related Disability and Productivity as Measured by the mMIDAS During the Last 4 Weeks of the 12-week Treatment Period | The modified MIDAS is a 5-item self-administered questionnaire that sums the number of productive days lost over the past month in two settings: the workplace and the home. The MIDAS also assesses disability in family, social, and leisure activities. The MIDAS score is the sum of missed days due to a headache from paid work, housework, and non-work (family, social, leisure) activities; and days at paid work or housework where productivity was reduced by at least half. |
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key inclusion Criteria:
Key exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Beijing | Beijing Municipality | 100000 | China | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42310529 | Derived | Yu S, Kim BK, Wang H, Zhou J, Banerjee P, Lincy J, Reshetnyak E, Li Z, Leclair D, Wang SJ. Long-term safety and continued clinical benefit of erenumab 70 mg in Asian patients with chronic migraine: an open-label extension of the phase 3 DRAGON study. J Headache Pain. 2026 Jun 17. doi: 10.1186/s10194-026-02406-y. Online ahead of print. | |
| 36404301 |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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A screening period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline period to assess diary compliance and headache frequency.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erenumab 70 mg | Administered by pre-filled syringe every 4 weeks starting at Day 1 |
| FG001 | Placebo | Placebo administered by pre-filled syringe at Day 1 and Weeks 4 and 8. Erenumab 70 mg administered by pre-filled syringe every 4 weeks starting at Week 12 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Period Until Week 12 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 26, 2021 | Jul 18, 2024 |
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| Placebo | Other | Administered by pre-filled syringe |
|
| baseline (4 weeks period prior to start of study drug), week 9 to 12 |
| Number of Participants With at Least 50% Reduction From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period | A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥4 continuous hours, and meeting at least one of the following criteria:
| baseline (4 weeks period prior to start of study drug), week 9 to 12 |
| Change From Baseline in Monthly Acute Headache Medication Days During the Last 4 Weeks of the 12-week Treatment Period | An acute headache medication day was defined as a day when medication was taken to treat acute headache. | baseline (4 weeks period prior to start of study drug), week 9 to 12 |
| Number of Subjects With Adverse Events as a Measure of Safety | Number of subjects with adverse events was assessed separately in the double-blind treatment period (DBTP) and the open-label treatment period (OLTP). | DBTP: 12 weeks for participants entering the OLTP. 20 weeks for participants NOT entering the OLTP. OLTP: From week 12 until up to approximately 4 years. |
| Number of Subjects With Anti-AMG 334 Antibodies | anti-AMG 334 antibodies assessed for binding and neutralizing) | baseline, 20 weeks |
| Beijing |
| Beijing Municipality |
| 100039 |
| China |
| Novartis Investigative Site | Xiamen | Fujian | 361001 | China |
| Novartis Investigative Site | Guangzhou | Guangdong | 510000 | China |
| Novartis Investigative Site | Shijiazhuang | Hebei | 500051 | China |
| Novartis Investigative Site | Zhengzhou | Henan | 450052 | China |
| Novartis Investigative Site | Jingzhou | Hubei | 434020 | China |
| Novartis Investigative Site | Wuhan | Hubei | 430060 | China |
| Novartis Investigative Site | Changsha | Hunan | 410003 | China |
| Novartis Investigative Site | Changsha | Hunan | 410008 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210008 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210029 | China |
| Novartis Investigative Site | Suzhou | Jiangsu | 215004 | China |
| Novartis Investigative Site | Wuxi | Jiangsu | 214002 | China |
| Novartis Investigative Site | Changchun | Jilin | 130021 | China |
| Novartis Investigative Site | Changchun | Jilin | 130041 | China |
| Novartis Investigative Site | Shenyang | Liaoning | 100016 | China |
| Novartis Investigative Site | Yinchuan | Ningxia | 100039 | China |
| Novartis Investigative Site | Jinan | Shandong | 250013 | China |
| Novartis Investigative Site | Xian | Shanxi | 710061 | China |
| Novartis Investigative Site | Chengdu | Sichuan | 610041 | China |
| Novartis Investigative Site | Kunming | Yunnan | 650000 | China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310006 | China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310016 | China |
| Novartis Investigative Site | Beijing | 065001 | China |
| Novartis Investigative Site | Beijing | 100050 | China |
| Novartis Investigative Site | Chongqing | 400016 | China |
| Novartis Investigative Site | Qingdao | 266000 | China |
| Novartis Investigative Site | Shanghai | 200040 | China |
| Novartis Investigative Site | Shanghai | 200080 | China |
| Novartis Investigative Site | Nashik | Maharashtra | 422005 | India |
| Novartis Investigative Site | Lucknow | Uttar Pradesh | 226014 | India |
| Novartis Investigative Site | Dehradun | Uttarakhand | 248001 | India |
| Novartis Investigative Site | Seberang Jaya | Pulau Pinang | 13700 | Malaysia |
| Novartis Investigative Site | Sungai Buloh | Selangor | 47000 | Malaysia |
| Novartis Investigative Site | Kuala Terengganu | Terengganu | 20400 | Malaysia |
| Novartis Investigative Site | Kuala Lumpur | 59100 | Malaysia |
| Novartis Investigative Site | Manila | National Capital Region | 1000 | Philippines |
| Novartis Investigative Site | Pasig | 1605 | Philippines |
| Novartis Investigative Site | Singapore | 169608 | Singapore |
| Novartis Investigative Site | Hwaseong-si | Gyeonggi-do | 18450 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 08308 | South Korea |
| Novartis Investigative Site | Gyeonggi-do | 11765 | South Korea |
| Novartis Investigative Site | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Seoul | 03181 | South Korea |
| Novartis Investigative Site | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Seoul | 139-711 | South Korea |
| Novartis Investigative Site | Chiayi City | 60002 | Taiwan |
| Novartis Investigative Site | Taichung | 40447 | Taiwan |
| Novartis Investigative Site | Taichung County | 411743 | Taiwan |
| Novartis Investigative Site | Tainan | 701 | Taiwan |
| Novartis Investigative Site | Tainan | 71004 | Taiwan |
| Novartis Investigative Site | Taipei | 10449 | Taiwan |
| Novartis Investigative Site | Taipei | 11217 | Taiwan |
| Novartis Investigative Site | Taipei | 114 | Taiwan |
| Novartis Investigative Site | Taoyuan | 33305 | Taiwan |
| Novartis Investigative Site | Bangkok | THA | 10400 | Thailand |
| Novartis Investigative Site | Khon Kaen | THA | 40002 | Thailand |
| Novartis Investigative Site | Bangkok | 10330 | Thailand |
| Novartis Investigative Site | Bangkok | 10400 | Thailand |
| Novartis Investigative Site | Chiang Mai | 50200 | Thailand |
| Novartis Investigative Site | Ho Chi Minh City | VNM | 700000 | Vietnam |
| Novartis Investigative Site | Hanoi | 100000 | Vietnam |
| Yu S, Kim BK, Wang H, Zhou J, Wan Q, Yu T, Lian Y, Arkuszewski M, Ecochard L, Wen S, Yin F, Li Z, Su W, Wang SJ. A phase 3, randomised, placebo-controlled study of erenumab for the prevention of chronic migraine in patients from Asia: the DRAGON study. J Headache Pain. 2022 Nov 21;23(1):146. doi: 10.1186/s10194-022-01514-9. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-Label Period From Week 12 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Erenumab 70 mg | Administered by pre-filled syringe at Day 1 and Weeks 4 and 8 |
| BG001 | Placebo | Administered by pre-filled syringe at Day 1 and Weeks 4 and 8 |
| 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 |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Change From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period | A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥4 continuous hours, and meeting at least one of the following criteria:
| Full Analysis Set. All randomized participants with evaluable measurements at the respective timepoint. | Posted | Least Squares Mean | Standard Error | days | baseline (4 weeks period prior to start of study drug), week 9 to 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Migraine-related Disability and Productivity as Measured by the mMIDAS During the Last 4 Weeks of the 12-week Treatment Period | The modified MIDAS is a 5-item self-administered questionnaire that sums the number of productive days lost over the past month in two settings: the workplace and the home. The MIDAS also assesses disability in family, social, and leisure activities. The MIDAS score is the sum of missed days due to a headache from paid work, housework, and non-work (family, social, leisure) activities; and days at paid work or housework where productivity was reduced by at least half. | Full Analysis Set. All randomized participants with evaluable measurements at the respective timepoint. | Posted | Least Squares Mean | Standard Error | days | baseline (4 weeks period prior to start of study drug), week 9 to 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With at Least 50% Reduction From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period | A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥4 continuous hours, and meeting at least one of the following criteria:
| Full Analysis Set. All randomized participants. | Posted | Count of Participants | Participants | baseline (4 weeks period prior to start of study drug), week 9 to 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Monthly Acute Headache Medication Days During the Last 4 Weeks of the 12-week Treatment Period | An acute headache medication day was defined as a day when medication was taken to treat acute headache. | Full Analysis Set. All randomized participants with evaluable measurements at the respective timepoint. | Posted | Least Squares Mean | Standard Error | days | baseline (4 weeks period prior to start of study drug), week 9 to 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Adverse Events as a Measure of Safety | Number of subjects with adverse events was assessed separately in the double-blind treatment period (DBTP) and the open-label treatment period (OLTP). | Safety Set (for DBTP). Number of participants entering the OLTP (for OLTP). | Posted | Count of Participants | Participants | DBTP: 12 weeks for participants entering the OLTP. 20 weeks for participants NOT entering the OLTP. OLTP: From week 12 until up to approximately 4 years. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Anti-AMG 334 Antibodies | anti-AMG 334 antibodies assessed for binding and neutralizing) | FAS including participants with a valid assessment | Posted | Count of Participants | Participants | baseline, 20 weeks |
|
|
Double-Blind Treatment Period: 12 weeks for participants entering the open-label treatment period. 20 weeks for participants NOT entering the open-label treatment period. Open-Label Treatment Period: From week 12 until up to approximately 4 years.
Not provided
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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 | Erenumab 70mg DBTP | double-blind treatment period (DBTP). Administered by pre-filled syringe at Day 1 and Weeks 4 and 8. | 0 | 279 | 7 | 279 | 58 | 279 |
| EG001 | Placebo DBTP | double-blind treatment period (DBTP). Administered by pre-filled syringe at Day 1 and Weeks 4 and 8. | 0 | 278 | 7 | 278 | 59 | 278 |
| EG002 | Erenumab 70mg OLTP (Erenumab 70mg in DBTP) | open-label treatment period (OLTP). Administered by pre-filled syringe every 4 weeks starting at week 12. | 0 | 224 | 21 | 224 | 92 | 224 |
| EG003 | Erenumab 70mg OLTP (Placebo in DBTP) | open-label treatment period (OLTP). Administered by pre-filled syringe every 4 weeks starting at week 12. | 0 | 232 | 24 | 232 | 120 | 232 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hyperplasia adrenal | Endocrine disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cataract cortical | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Gastrointestinal polyp | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Salivary gland calculus | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Chronic hepatitis B | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Joint capsule rupture | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Tooth injury | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Axial spondyloarthritis | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Endometrial stromal sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Intraductal papillary breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Myelitis transverse | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Occipital neuralgia | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Cystitis glandularis | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Abnormal uterine bleeding | Reproductive system and breast disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cervical polyp | Reproductive system and breast disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Uterine adhesions | Reproductive system and breast disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 20, 2021 | Jul 18, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000605816 | erenumab |
Not provided
Not provided
Not provided
| Physician Decision |
|
| Pregnancy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| No longer clinically benefiting |
|
| New Therapy for Study Indication |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|