Clinical trial NCT01890109: Study of Erenumab (AMG 334) in Women With Hot Flashes
Official title: Randomized, Stratified, Parallel-group, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 334 in Women With Hot Flashes Associated With Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vasomotor Symptoms; Hot Flashes
Keywords: Vasomotor symptoms; Hot Flashes; Menopause
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-07-01
Enrollment: 103
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study was to evaluate the frequency of moderate to severe daily hot flashes 4 weeks after a single dose of erenumab (AMG 334) in women with hot flashes associated with menopause.

Detailed description: This study will test the hypothesis that the vasodilation associated with capsaicin-induced dermal blood flow (DBF) provides a good model for the vasodilation associated with hot flashes; therefore erenumab doses that cause DBF inhibition will be safe and well tolerated, and will be effective in the reduction of the frequency and/or severity of HFs.

Eligibility criteria: Inclusion Criteria:

* female subjects with hot flashes associated with menopause between 45 and 65 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.

Primary outcomes:
measure: Ratio of Week 4 to Baseline Average Number of Daily Moderate to Severe Hot Flashes
timeFrame: Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27)
Secondary outcomes:
measure: Ratio of Week 4 to Baseline Daily Hot Flash Severity Score
timeFrame: Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27)
measure: Number of Participants With Treatment-emergent Adverse Events
timeFrame: 16 weeks
measure: Maximum Observed Concentration (Cmax) of Erenumab After a Single Dose
timeFrame: Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
measure: Time to Maximum Observed Concentration (Tmax) of Erunumab After a Single Dose
timeFrame: Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
measure: Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) for Erenumab
timeFrame: Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
measure: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Erenumab
timeFrame: Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
measure: Terminal Half-life (T1/2) of Erenumab
timeFrame: Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
measure: Number of Participants With Treatment-emergent Suicidal Ideation
timeFrame: 16 weeks
measure: Number of Participants Who Developed Anti-erenumab Antibodies After a Single Dose
timeFrame: 16 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Research Site
state: California
city: Miami
country: United States
facility: Research Site
state: Florida
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Philadelphia
country: United States
facility: Eugene Andruczyk
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Research Site
state: South Carolina
city: Seattle
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: