MigrainePhase 1NCT01688739

Ascending Single Doses of Erenumab (AMG 334) in Healthy Adults and Migraine Patients

A Phase 1 study testing Erenumab in people with Migraine, run by Amgen at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Migraine
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: 61 participants
Where: 1 siteBelgium
Study dates: 13 Mar 2012to 27 Mar 2013
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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female subjects between 18 and 45 years of age, or male or female subjects with migraines between 18 and 55 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

1 site in 1 country.

Belgium1 site

Research Site
Leuven, 3000

Other trials in Belgium

About this study

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 334 in Healthy Subjects and Migraine Patients

The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of erenumab after single subcutaneous (SC) or intravenous (IV) doses in healthy participants and migraine patients as well as to characterize the effect of erenumab on the capsaicin-induced increase in dermal blood flow after single SC or IV doses in healthy participants and migraine patients.

Read the detailed description

This study was a single-dose, double-blind, placebo-controlled, sequential dose escalation study in which participants were to be enrolled into 8 cohorts.

In Part 1 healthy participants were randomized in a 3:1 ratio (erenumab:placebo) into 6 cohorts: 5 cohorts received the investigational product (IP) as an SC administration and 1 cohort received it as an IV administration. In Part 2 a total of 12 migraine patients were randomized in a 1:1 ratio (erenumab:placebo) in cohort 7. An additional 8 migraine patients could have been enrolled and randomized in a 3:1 ratio in the optional cohort 8, however this cohort was not enrolled.

Conditions: Migraine
Being tested: Erenumab, Placebo
Keywords: Migraine
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ErenumabDrug
Also called AMG 334, Aimovig™
Administered by subcutaneous injection or intravenous injection
PlaceboDrug
Administered by subcutaneous injection or intravenous injection

Study groups in NCT01688739
Study group	Role	What they receive
Erenumab	Experimental	Participants received a single dose of erenumab by subcutaneous injection at doses of 1 mg, 7 mg, 21 mg, 70 mg, 140 mg, and 210 mg or by IV injection at a dose of 140 mg. Receives: Drug: Erenumab
Placebo	Placebo comparator	Participants received a single dose of matching placebo administered by SC or IV injection. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events.
Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug.
A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:
- fatal
- life-threatening (places the subject at immediate risk of death)
- requires in-patient hospitalization or prolongation of existing hospitalization
- results in persistent or significant disability/incapacity
- congenital anomaly/birth defect
- other medically important serious event.
Measured: From the initial dose of study drug up to 155 days.
Number of Participants Who Developed Anti-erenumab Antibodies
Participants who had a negative or no result at baseline and were antibody positive postbaseline. Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies.
Measured: Baseline and up to 155 days postdose

Secondary outcomes (5)

Maximum Observed Concentration (Cmax) of Erenumab
Measured: Predose to 155 days postdose
Time to Maximum Observed Concentration (Tmax) of Erenumab
Measured: Predose to 155 days postdose
Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Erenumab
Measured: Predose to 155 days postdose
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Erenumab
Measured: Predose to 155 days postdose
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Inhibition of capsaicin-induced dermal blood flow (DBF) by erenumab was used to measure calcitonin gene-related peptide (CGRP) receptor antagonism. Capsaicin was applied at 2 sites on the volar surface of the participants' left or right forearms and a control mixture was applied to 1 site on the volar surface of either the participants' left or right forearm. Dermal blood flow was assessed by laser Doppler perfusion imaging and was done immediately before ('baseline') and 0.5 hours post-capsaicin on the surface of these 3 sites.
Data reported are the least square geometric mean ratios for the post-capsaicin dermal blood flow to pre-capsaicin dermal blood flow.
According to the protocol, not all cohorts had dermal blood flow measurements at all time points.
Measured: Days 4, 15, 29, 43, 64, 85, 99, 127, and end of study (defined as day 43 for the 1 mg, 7 mg and 21 mg erenumab cohorts, day 99 for the 70 mg erenumab cohort, day 127 for the 140 mg erenumab cohorts and day 155 for the 210 mg erenumab cohort).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 201227 Mar 2013

First posted20 Sep 2012 (estimated)
Study start13 Mar 2012
Primary completion27 Mar 2013
Study completion27 Mar 2013

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MigraineStudies 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: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01688739
Sponsor's protocol ID: 20101267
Other IDs: 2011-005600-15
Status last verified: Aug 2018
First submitted: 17 Sep 2012
Last updated: 18 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Vu T, Ma P, Chen JS, de Hoon J, Van Hecken A, Yan L, Wu LS, Hamilton L, Vargas G. Pharmacokinetic-Pharmacodynamic Relationship of Erenumab (AMG 334) and Capsaicin-Induced Dermal Blood Flow in Healthy and Migraine Subjects. Pharm Res. 2017 Sep;34(9):1784-1795. doi: 10.1007/s11095-017-2183-6. Epub 2017 Jun 7.
PubMed 28593473
de Hoon J, Van Hecken A, Vandermeulen C, Yan L, Smith B, Chen JS, Bautista E, Hamilton L, Waksman J, Vu T, Vargas G. Phase I, Randomized, Double-blind, Placebo-controlled, Single-dose, and Multiple-dose Studies of Erenumab in Healthy Subjects and Patients With Migraine. Clin Pharmacol Ther. 2018 May;103(5):815-825. doi: 10.1002/cpt.799. Epub 2017 Oct 24.
PubMed 28736918

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 334 in Healthy Subjects and Migraine Patients
ClinicalTrials.gov ID: NCT01688739
Acronym / sponsor ID: 20101267
Conditions: Migraine
Keywords: Migraine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 13 Mar 2012 (actual)
Primary completion: 27 Mar 2013 (actual)
Study completion: 27 Mar 2013 (actual)
First posted: 20 Sep 2012 (estimated)
Results: Posted 18 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study was a single-dose, double-blind, placebo-controlled, sequential dose escalation study in which participants were to be enrolled into 8 cohorts.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Erenumab	Experimental	Drug: ErenumabParticipants received a single dose of erenumab by subcutaneous injection at doses of 1 mg, 7 mg, 21 mg, 70 mg, 140 mg, and 210 mg or by IV injection at a dose of 140 mg.
Placebo	Placebo comparator	Drug: PlaceboParticipants received a single dose of matching placebo administered by SC or IV injection.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy male and female subjects between 18 and 45 years of age, or male or female subjects with migraines between 18 and 55 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 by subcutaneous injection or intravenous injection	Drug	Erenumab
PlaceboAdministered by subcutaneous injection or intravenous injection	Drug	Placebo

Primary outcome

Number of Participants With Adverse Events
Time frame: From the initial dose of study drug up to 155 days.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events. Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: * fatal * life-threatening (places the subject at immediate risk of death) * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.
Number of Participants Who Developed Anti-erenumab Antibodies
Time frame: Baseline and up to 155 days postdose
Participants who had a negative or no result at baseline and were antibody positive postbaseline. Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies.

5 secondary outcomes

Maximum Observed Concentration (Cmax) of Erenumab
Time frame: Predose to 155 days postdose
Time to Maximum Observed Concentration (Tmax) of Erenumab
Time frame: Predose to 155 days postdose
Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Erenumab
Time frame: Predose to 155 days postdose
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Erenumab
Time frame: Predose to 155 days postdose
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
Time frame: Days 4, 15, 29, 43, 64, 85, 99, 127, and end of study (defined as day 43 for the 1 mg, 7 mg and 21 mg erenumab cohorts, day 99 for the 70 mg erenumab cohort, day 127 for the 140 mg erenumab cohorts and day 155 for the 210 mg erenumab cohort).

Results and safety

Results posted to the registry on 18 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy: Placebo	13	12
Healthy: Erenumab 1 mg SC	3	3
Healthy: Erenumab 7 mg SC	3	3
Healthy: Erenumab 21 mg SC	6	6
Healthy: Erenumab 70 mg SC	6	6
Healthy: Erenumab 140 mg SC	6	6
Healthy: Erenumab 140 mg IV	6	6
Healthy: Erenumab 210 mg SC	6	6
Migraine: Placebo	6	6
Migraine: Erenumab 140 mg SC	6	6

Primary outcome: Number of Participants With Adverse Events

Time frame: From the initial dose of study drug up to 155 days.. Count of participants. Unit: Participants

Measure	Healthy: Placebo n = 12	Healthy: Erenumab 1 mg SC n = 3	Healthy: Erenumab 7 mg SC n = 3	Healthy: Erenumab 21 mg SC n = 6	Healthy: Erenumab 70 mg SC n = 6	Healthy: Erenumab 140 mg SC n = 6	Healthy: Erenumab 140 mg IV n = 6	Healthy: Erenumab 210 mg SC n = 6	Migraine: Placebo n = 6	Migraine: Erenumab 140 mg SC n = 6
Any adverse event	10	2	1	6	5	5	5	6	5	6
Serious adverse event	0	0	0	0	0	0	0	0	0	0
AE leading to discontinuation of study drug	0	0	0	0	0	0	0	0	0	0
AE leading to discontinuation from study	0	0	0	0	0	0	0	0	0	0
Fatal adverse events	0	0	0	0	0	0	0	0	0	0
Treatment-related adverse events	4	0	0	0	1	1	2	4	0	0

Population analysed: All participants who received study drug.

Primary outcome: Number of Participants Who Developed Anti-erenumab Antibodies

Time frame: Baseline and up to 155 days postdose. Count of participants. Unit: Participants

Measure	Healthy: Placebo n = 12	Healthy: Erenumab 1 mg SC n = 3	Healthy: Erenumab 7 mg SC n = 3	Healthy: Erenumab 21 mg SC n = 6	Healthy: Erenumab 70 mg SC n = 6	Healthy: Erenumab 140 mg SC n = 6	Healthy: Erenumab 140 mg IV n = 6	Healthy: Erenumab 210 mg SC n = 6	Migraine: Placebo n = 6	Migraine: Erenumab 140 mg SC n = 6
Binding antibody positive	0	0	0	0	1	0	0	0	0	0
Neutralizing antibody positive	0	0	0	0	0	0	0	0	0	0

Population analysed: All participants who received study drug

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the initial dose of study drug up to 155 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy: Placebo	0 of 12 (0%)	10 of 12 (83.3%)	Not reported
Healthy: Erenumab 1 mg SC	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
Healthy: Erenumab 7 mg SC	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
Healthy: Erenumab 21 mg SC	0 of 6 (0%)	6 of 6 (100%)	Not reported
Healthy: Erenumab 70 mg SC	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Healthy: Erenumab 140 mg SC	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Healthy: Erenumab 140 mg IV	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Healthy: Erenumab 210 mg SC	0 of 6 (0%)	6 of 6 (100%)	Not reported
Migraine: Placebo	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Migraine: Erenumab 140 mg SC	0 of 6 (0%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28593473Vu T, Ma P, Chen JS, de Hoon J, Van Hecken A, Yan L, Wu LS, Hamilton L, Vargas G. Pharmacokinetic-Pharmacodynamic Relationship of Erenumab (AMG 334) and Capsaicin-Induced Dermal Blood Flow in Healthy and Migraine Subjects. Pharm Res. 2017 Sep;34(9):1784-1795. doi: 10.1007/s11095-017-2183-6. Epub 2017 Jun 7.
Background: PubMed 28736918de Hoon J, Van Hecken A, Vandermeulen C, Yan L, Smith B, Chen JS, Bautista E, Hamilton L, Waksman J, Vu T, Vargas G. Phase I, Randomized, Double-blind, Placebo-controlled, Single-dose, and Multiple-dose Studies of Erenumab in Healthy Subjects and Patients With Migraine. Clin Pharmacol Ther. 2018 May;103(5):815-825. doi: 10.1002/cpt.799. Epub 2017 Oct 24.
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

1 site 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 Migraine, run by Amgen at 1 site in Belgium.

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 18 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 1 site in Belgium. 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 18 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?

Number of Participants With Adverse Events (time frame: From the initial dose of study drug up to 155 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01688739, which also lists 2 linked publications.

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 18 Jan 2019.