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Study Complete
Sponsor ID
20170609

A Controlled Trial of Erenumab in Migraine Prevention

Sponsor ID
20170609
Clinicaltrials.gov ID
NCT03812224
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study was to assess the efficacy and safety of erenumab for prevention of migraine in Japanese adults with episodic migraine (EM) and chronic migraine (CM).

Additional Study Details

Phase
Phase 3
Product
AMG 334
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
261
Additional Study Details

Protocol Summary

Primary Outcome Measures

Mean Monthly Migraine Days

Timeframe: 67 weeks

Secondary Outcome Measures

50% reduction in MMD

Timeframe: 67 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Hofu-shi, Yamaguchi, Japan, 747-0802
Status
Recruiting
Location
Research Site
Yamaguchi-shi, Yamaguchi, Japan, 754-0002
Status
Recruiting
Location
Research Site
Kyoto-shi, Kyoto, Japan, 600-8811
Status
Recruiting
Location
Research Site
Sendai-shi, Miyagi, Japan, 982-0014
Status
Recruiting
Location
Research Site
Shibuya-ku, Tokyo, Japan, 151-0051
Status
Recruiting
Location
Research Site
Kagoshima-shi, Kagoshima, Japan, 892-0844
Status
Recruiting
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Study Info
Age
20 - 65 Years
Condition
  • Migraine
    • Sex
    All
    Trial Dates
    Apr 2019 - Mar 2020
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures. • Japanese subjects greater than or equal to 20 to less than or equal to 65 years of age upon entry into screening. • History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the International Headache Society Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report • Migraine frequency: Chronic Migraine (CM) or Episodic Migraine (EM) over the 3 months before screening based on the following criteria: (a) CM is defined as greater than or equal to 15 headache days per month of which greater than or equal to 8 headache days on average across the 3 months meet criteria as migraine days (b) EM is defined as less than 15 headache days per month of which at least 4 or more headache days on average across the 3 months meet criteria as migraine days
    Exclusion Criteria:
    • Subjects greater than 50 years of age at migraine onset. • History of cluster headache or hemiplegic migraine headache. • Unable to differentiate migraine from other headaches. • Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period. • Malignancy, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years. Other exclusion criteria may apply