Vasomotor Symptoms; Hot Flashes Clinical Trial
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
| Verified date | January 2019 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 103 |
| Est. completion date | March 11, 2014 |
| Est. primary completion date | March 11, 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 45 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Miami | Florida |
| United States | Research Site | Mount Pleasant | South Carolina |
| United States | Eugene Andruczyk | Philadelphia | Pennsylvania |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | San Diego | California |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Ratio of Week 4 to Baseline Average Number of Daily Moderate to Severe Hot Flashes | The severity of hot flashes was assessed by participants based on the following categories: Mild: sensation of heat without sweating, mild flushing; Moderate: sensation of heat, face flushed, slightly clammy, some sweating, able to continue activity, may want to remove layers of clothing or covers at night; Severe: sensation of heat with more severe sweating, have to stop current activity, may have to change clothing. Baseline (BL) number of hot flashes is the average number of moderate or severe hot flashes per 24 hours from day -7 to day 1 predose based on geometric mean, and the week 4 number of hot flashes is the average number of moderate or severe hot flashes per 24 hours from day 21 to day 27 based on geometric mean. The ratio of week 4 to BL was used to assess change from BL to week 4 via a log transformation (log[week4/BL] = log[week4] - log[BL]), which was estimated using a repeated measures analysis. The ratio was obtained via an exponential back-transformation. |
Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27) | |
| Secondary | Ratio of Week 4 to Baseline Daily Hot Flash Severity Score | The daily severity score was calculated according to the following: (Number of mild hot flashes * 1) + (number of moderate hot flashes * 2) + (number of severe hot flashes * 3). The baseline daily hot flash severity score is the geometric mean daily hot flash severity score from day -7 to day 1 predose, and the week 4 daily hot flash severity score is the geometric mean daily hot flash severity score from day 21 to day 27. The ratio of week 4 to baseline (week 4 / baseline) was used to assess change from baseline to week 4 via a log transformation (log[week4/BL] = log[week4] - log[baseline]), which was estimated using a repeated measures analysis. The ratio was obtained via an exponential back-transformation. |
Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27) | |
| Secondary | Number of Participants With Treatment-emergent Adverse Events | A treatment-emergent adverse event is any adverse event that began or worsened after the initial dose of study drug and before the end of study. A serious adverse event is an adverse event that met at least 1 of the following serious criteria: fatal life threatening required inpatient hospitalization or prolongation of existing hospitalization resulted in persistent or significant disability/incapacity congenital anomaly/birth defect. other medically important serious event A treatment-related adverse event (TRAE) is any treatment-emergent adverse event that per investigator review had a reasonable possibility of being caused by the study drug. |
16 weeks | |
| Secondary | Maximum Observed Concentration (Cmax) of Erenumab After a Single Dose | Blood samples were analyzed using an enzyme-linked immunosorbent assay (ELISA) following a validated analytical procedure. | Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose | |
| Secondary | Time to Maximum Observed Concentration (Tmax) of Erunumab After a Single Dose | Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose | ||
| Secondary | Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) for Erenumab | Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose | ||
| Secondary | Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Erenumab | Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose | ||
| Secondary | Terminal Half-life (T1/2) of Erenumab | Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose | ||
| Secondary | Number of Participants With Treatment-emergent Suicidal Ideation | The Columbia Suicide Severity Rating Scale (C-SSRS) was used to assess suicidal ideation during the study based on the following Yes/No questions: Have you wished you were dead or wished you could go to sleep and not wake up? Have you actually had any thoughts of killing yourself? |
16 weeks | |
| Secondary | Number of Participants Who Developed Anti-erenumab Antibodies After a Single Dose | Two validated assays were used to detect the presence of anti-erenumab antibodies. First, an electrochemiluminescent (ECL) bridging immunoassay was used to detect antibodies capable of binding erenumab. Second, a cell based bioassay was used to test positive binding antibody samples for neutralizing activity against erenumab. A participant was defined as positive for developing anti-erenumab antibodies if they were binding antibody positive postbaseline with a negative or no result at baseline. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the participant was defined as positive for neutralizing antibodies. |
16 weeks |