Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
NCT ID: NCT03333109
Last Updated: 2021-10-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
900 participants
INTERVENTIONAL
2018-02-08
2020-01-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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AMG334 70 mg
AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
Erenumab
70 mg/mL pre-filled syringe administered subcutaneously
AMG334 140 mg
AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
Erenumab
70 mg/mL pre-filled syringe administered subcutaneously
Placebo
Two pre-filled syringes containing placebo identical in appearance to erenumab
Placebo
Matching placebo in pre-filled syringe administered subcutaneously
Interventions
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Erenumab
70 mg/mL pre-filled syringe administered subcutaneously
Placebo
Matching placebo in pre-filled syringe administered subcutaneously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 4-14 days per month of migraine symptoms
3. \>=80% diary compliance during the Baseline period
Exclusion Criteria
2. Pregnant or nursing
3. History of cluster or hemiplegic headache
4. Evidence of seizure or major psychiatric disorder
5. Score of 19 or higher on the BDI
6. Active chronic pain syndrome
7. Cardiac or hepatic disease
18 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
CABA, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Ciudad Autonoma de Bs As, , Argentina
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Córdoba, , Argentina
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Guntur, Andhra Pradesh, India
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Ahmedabad, Gujarat, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Mysore, Karnataka, India
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Kochi, Kerala, India
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Kochi, Kerala, India
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Kozhikode, Kerala, India
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Thiruvananthapuram, Kerala, India
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Mumbai, Maharashtra, India
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Mumbai, Maharashtra, India
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Nagpur, Maharashtra, India
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Nashik, Maharashtra, India
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Nashik, Maharashtra, India
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Pune, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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New Delhi, National Capital Territory of Delhi, India
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Ludhiana, Punjab, India
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Chennai, Tamil Nadu, India
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Hyderabad, Telangana, India
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Lucknow, Uttar Pradesh, India
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Dehradun, Uttarakhand, India
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Kolkata, West Bengal, India
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Kolkata, West Bengal, India
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Belagavi, , India
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Mumbai, , India
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New Delhi, , India
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El Chouf, LBN, Lebanon
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Beirut, , Lebanon
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Beirut, , Lebanon
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Beirut, , Lebanon
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Beirut, , Lebanon
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Kuala Lumpur, Kuala Lumpur, Malaysia
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Kuala Lumpur, MYS, Malaysia
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Seberang Jaya, Pulau Pinang, Malaysia
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Sungai Buloh, Selangor, Malaysia
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Kuala Lumpur, , Malaysia
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Monterrey, Nuevo León, Mexico
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Chihuahua City, , Mexico
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Manila, National Capital Region, Philippines
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Manila, National Capital Region, Philippines
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Pasig, , Philippines
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Quezon City, , Philippines
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Singapore, , Singapore
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Singapore, , Singapore
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Hwaseong-si, Gyeonggi-do, South Korea
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Daejeon, Korea, South Korea
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Seoul, Korea, South Korea
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Seoul, KOR, South Korea
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Seoul, KOR, South Korea
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Busan, , South Korea
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Gwangju, , South Korea
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Gyeonggi-do, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Chiayi City, , Taiwan
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Taichung, , Taiwan
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Taichung County, , Taiwan
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Tainan City, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, THA, Thailand
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Khon Kaen, THA, Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Ho Chi Minh City, VNM, Vietnam
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Hanoi, , Vietnam
Countries
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References
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Lampl C, Kraus V, Lehner K, Loop B, Chehrenama M, Maczynska Z, Ritter S, Klatt J, Snellman J. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4.
Wang SJ, Roxas AA Jr, Saravia B, Kim BK, Chowdhury D, Riachi N, Tai MS, Tanprawate S, Ngoc TT, Zhao YJ, Mikol DD, Pandhi S, Wen S, Mondal S, Tenenbaum N, Hours-Zesiger P. Randomised, controlled trial of erenumab for the prevention of episodic migraine in patients from Asia, the Middle East, and Latin America: The EMPOwER study. Cephalalgia. 2021 Nov;41(13):1285-1297. doi: 10.1177/03331024211024160. Epub 2021 Jun 25.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on novartisclinicaltrials.com
Other Identifiers
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CAMG334A2302
Identifier Type: -
Identifier Source: org_study_id
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