Vasomotor Symptoms; Hot FlashesPhase 1NCT01890109
Study of Erenumab (AMG 334) in Women With Hot Flashes
A Phase 1 study testing Erenumab in people with Vasomotor Symptoms; Hot Flashes, run by Amgen at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Vasomotor Symptoms; Hot Flashes
- What is being tested?
- Erenumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 May 2013to 11 Mar 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Research Site
Miami, Florida, 33186
Research Site
Mt. Pleasant, South Carolina, 29464
Eugene Andruczyk
Philadelphia, Pennsylvania, 19114
Research Site
Philadelphia, Pennsylvania, 19114
Research Site
San Diego, California, 92108
Research Site
Seattle, Washington, 98105
Research Site
Winston-Salem, North Carolina, 27103
About this study
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
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.
Read the 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.
- Conditions
- Vasomotor Symptoms; Hot Flashes
- Being tested
- Erenumab, Placebo
- Keywords
- Vasomotor symptoms; Hot Flashes; Menopause
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErenumabBiological
Also called AMG 334, Aimovig™
Administered via subcutaneous injection.
PlaceboDrug
Administered via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received a single dose of placebo administered by subcutaneous injection. Receives: Drug: Placebo |
| Erenumab | Experimental | Participants received a single dose of 70 mg erenumab administered by subcutaneous injection. Receives: Biological: Erenumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27)
Secondary outcomes (9)
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.
Measured: Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27)
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.
Measured: 16 weeks
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.
Measured: Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
Time to Maximum Observed Concentration (Tmax) of Erunumab After a Single Dose
Measured: Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) for Erenumab
Measured: Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Erenumab
Measured: Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
Terminal Half-life (T1/2) of Erenumab
Measured: Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
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?
Measured: 16 weeks
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study start13 May 2013
- Primary completion11 Mar 2014
- Study completion11 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vasomotor Symptoms; Hot FlashesStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890109
- Sponsor's protocol ID
- 20120180
- Status last verified
- Jan 2019
- First submitted
- 13 May 2013
- Last updated
- 14 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01890109
- Acronym / sponsor ID
- 20120180
- Conditions
- Vasomotor Symptoms; Hot Flashes
- Keywords
- Vasomotor symptoms; Hot Flashes; Menopause
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 13 May 2013 (actual)
- Primary completion
- 11 Mar 2014 (actual)
- Study completion
- 11 Mar 2014 (actual)
- First posted
- 1 Jul 2013 (estimated)
- Results
- Posted 14 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received a single dose of placebo administered by subcutaneous injection. |
| Erenumab | Experimental | Biological: ErenumabParticipants received a single dose of 70 mg erenumab administered by subcutaneous injection. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErenumabAlso: AMG 334, Aimovig™Administered via subcutaneous injection. | Biological | Erenumab |
| PlaceboAdministered via subcutaneous injection | Drug | Placebo |
Primary outcome
Ratio of Week 4 to Baseline Average Number of Daily Moderate to Severe Hot Flashes
Time frame: Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27)
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.
9 secondary outcomes
Ratio of Week 4 to Baseline Daily Hot Flash Severity Score
Time frame: Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27)
Number of Participants With Treatment-emergent Adverse Events
Time frame: 16 weeks
Maximum Observed Concentration (Cmax) of Erenumab After a Single Dose
Time frame: Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
Time to Maximum Observed Concentration (Tmax) of Erunumab After a Single Dose
Time frame: Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) for Erenumab
Time frame: Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Erenumab
Time frame: Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
Terminal Half-life (T1/2) of Erenumab
Time frame: Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
Number of Participants With Treatment-emergent Suicidal Ideation
Time frame: 16 weeks
Number of Participants Who Developed Anti-erenumab Antibodies After a Single Dose
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Erenumab in people with Vasomotor Symptoms; Hot Flashes, run by Amgen at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of Week 4 to Baseline Average Number of Daily Moderate to Severe Hot Flashes (time frame: Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.