MigrainePhase 1NCT02542605
To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients
A Phase 1 study testing Erenumab and PACAP-38 Challenge Agent in people with Migraine, run by Amgen at 3 sites in 3 countries.
Trial summary
Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced Migraine-like Attacks in Migraine Patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Migraine
- What is being tested?
- Erenumab and PACAP-38 Challenge Agent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 11 Nov 2015to 8 Nov 2017
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults ≥ 18 to ≤ 45 years of age upon entry into screening
- History of migraine headaches without aura for ≥ 6 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-II) (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report
- Migraine frequency: ≥ 1 and ≤ 5 migraine days per month in each of the 3 months prior to screening
Who cannot join
- History of migraine with aura, cluster headache or hemiplegic migraine headache according to the IHS Classification ICHD-II (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report
- ≥ 6 migraine days per month in the last 3 months prior to study enrollment and during screening period
- Other headache disorders (except for episodic tension-type headache <5 days/month)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced Migraine-like Attacks in Migraine Patients
Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced Migraine-like Attacks in Migraine Patients.
- Conditions
- Migraine
- Being tested
- Erenumab, Placebo, PACAP-38 Challenge Agent
- Keywords
- Migraine, Headache, Migraine Headache, Headache, Migraine, Amgen
- Medical subject headings
- Migraine Disorders, Headache
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 once on day 1 of Part B of the study by intravenous infusion.
PlaceboDrug
Administered once on day 1 of Part B of the study by intravenous infusion.
PACAP-38 Challenge AgentDrug
Also called Pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38)
Administered by intravenous infusion during Part A of the study for dose selection for Part B.
Administered by intravenous infusion on day 8 in Part B as a challenge agent to induce a migraine-like attack.
| Study group | Role | What they receive |
|---|---|---|
| PACAP-38 Challenge Agent | Other | In Part A, 4 cohorts of 2 to 5 participants sequentially received an intravenous infusion of 10 picomol/kilogram/minute (pmol/kg/minute) PACAP-38 for 2.5, 5, 7.5 and 10 minutes each in order to determine the dose for Part B. Receives: Drug: PACAP-38 Challenge Agent |
| Placebo | Placebo comparator | Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1. On day 8 participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks. Receives: Drug: Placebo; Drug: PACAP-38 Challenge Agent |
| Erenumab | Experimental | Participants were randomized to receive 140 milligrams (mg) erenumab by intravenous administration over 30 minutes on day 1 in Part B. On day 8 participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks. Receives: Drug: Erenumab; Drug: PACAP-38 Challenge Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a MLA Within 24 Hours of Challenge Agent Infusion
On day 1 of the double-blind randomization phase participants received 140 mg intravenous erenumab over 30 minutes or matching placebo. On day 8, participants received 10 mol/kg/minute PACAP-38 over 10 minutes and were observed for 24 hours after PACAP-38 infusion.
A MLA was defined as fulfilling 1 of the 2 criteria:
- Headache with at least 2 of the following characteristics: unilateral location, pulsating quality, moderate or severe pain intensity, aggravated by/causing avoidance of routine physical activity. Additionally, during the headache at least 1 of the following: nausea and/or vomiting, photophobia or phonophobia.
- Headache described as mimicking usual migraine attack treated with triptan.
Measured: Part B randomization phase day 8 plus 24 hours.
Secondary outcomes (21)
Number of Participants With a Headache Within 24 Hours of Challenge Agent Infusion
On day 1 of the double-blind randomization phase participants received 140 mg intravenous erenumab over 30 minutes or matching placebo. On day 8, participants received 10 mol/kg/minute PACAP-38 over 10 minutes and were observed for 24 hours after PACAP-38 infusion.
Measured: Part B randomization phase day 8 plus 24 hours.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs were summarised for days 1 to 7 after the participants received placebo or erenumab infusion on day 1 of the Part B randomization phase. TEAEs were also summarized from day 8 to end of study (EOS) after participants had received both investigational product (placebo or erenumab) and the second dose of PACAP-38 on day 8.
Measured: Part B randomization phase day 1 until EOS (up to 12 weeks).
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Day 1, Day 8 and EOS
Systolic and diastolic BP was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.
Measured: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).
Mean Change From Baseline in Heart Rate at Day 1, Day 8 and EOS
Heart rate was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.
Measured: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).
Mean Change From Baseline in Respiratory Rate at Day 1, Day 8 and EOS
Respiratory rate was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.
Measured: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).
Mean Change From Baseline in Temperature at Day 1, Day 8 and EOS
Temperature was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.
Measured: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS
ALP, ALT and AST were assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Measured: Part B randomization phase baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Total Bilirubin at Day 8, Day 9 and EOS
Total bilirubin was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Measured: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Blood Urea at Day 8, Day 9 and EOS
Blood urea was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Measured: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Creatine Kinase at Day 8, Day 9 and EOS
Creatine Kinase was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Measured: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Creatinine at Day 8, Day 9 and EOS
Creatinine was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Measured: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Direct Bilirubin at Day 8, Day 9 and EOS
Direct bilirubin was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Measured: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Eosinophil Count at Day 8, Day 9 and EOS
Eosinophil count was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Measured: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Blood Glucose at Day 8, Day 9 and EOS
Blood glucose was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Measured: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Hemoglobin A1C (Fraction of 1) at Day 8, Day 9 and EOS
Hemoglobin A1C was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.
Measured: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Pharmacokinetics (PK): Mean Erenumab Serum Concentration at 1 Hour (C1h)
The mean serum erenumab concentration at 1 hour post-dose on day 1 of Part B randomization phase is presented.
Measured: Part B randomization phase 1 hour post-dose day 1.
PK: Mean Area Under the Concentration-time Curve From Time 0 to 84 Days Post-dose (AUC84d)
The mean AUC84d for erenumab for the Part B randomization phase is presented.
Measured: Part B randomization phase baseline and 84 days post-dose.
Number of Participants With Anti-Erenumab Antibodies
Participants were tested for binding antibodies and neutralizing antibodies at baseline and following treatment with erenumab.
Measured: Part B randomization phase baseline and EOS.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
At baseline, 12-lead ECGs were performed in a standardized method, in triplicate, and approximately 30 seconds apart, prior to blood draws or other invasive procedures. Single ECGs were performed from Day 1 to EOS. ECG results were reviewed by the investigator and classified as: normal, abnormal not clinically significant or abnormal, clinically significant. The number of participants with abnormal, clinically significant changes in ECG results at EOS are presented.
Measured: Part B randomization phase baseline and EOS.
Number of Participants With Clinically Significant Changes in Physical Parameters
Physical examinations were performed by an investigator and any abnormal findings, judged to be clinically significant were recorded as an AE. The number of participants with clinically significant changes in physical parameters at EOS are presented.
Measured: Part B randomization phase baseline and EOS.
Number of Participants With Clinically Significant Changes in Neurological Assessments
Neurological examinations including assessment of cranial nerves, motor system, sensory system (including testing for pain sensation [pin prick], light touch sensation [brush], von Frey, and vibratory sense), reflexes, and cerebellar function were performed by the investigator and classified as normal or abnormal. Any abnormal findings, judged by the investigator to be clinically significant, were recorded as an AE. The number of participants with clinically significant changes in neurological assessments at EOS are presented.
Measured: Part B randomization phase baseline and EOS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study start11 Nov 2015
- Primary completion28 Sep 2017
- Study completion8 Nov 2017
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 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 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
- NCT02542605
- Sponsor's protocol ID
- 20140207
- Status last verified
- Feb 2019
- First submitted
- 3 Sep 2015
- Last updated
- 3 Jun 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 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced Migraine-like Attacks in Migraine Patients
- ClinicalTrials.gov ID
- NCT02542605
- Acronym / sponsor ID
- 20140207
- Conditions
- Migraine
- Keywords
- Migraine, Headache, Migraine Headache, Headache, Migraine, Amgen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2015 (actual)
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 8 Nov 2017 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced Migraine-like Attacks in Migraine Patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PACAP-38 Challenge Agent | Other | Drug: PACAP-38 Challenge AgentIn Part A, 4 cohorts of 2 to 5 participants sequentially received an intravenous infusion of 10 picomol/kilogram/minute (pmol/kg/minute) PACAP-38 for 2.5, 5, 7.5 and 10 minutes each in order to determine the dose for Part B. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: PACAP-38 Challenge AgentParticipants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1. On day 8 participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks. |
| Erenumab | Experimental | Drug: Erenumab, Drug: PACAP-38 Challenge AgentParticipants were randomized to receive 140 milligrams (mg) erenumab by intravenous administration over 30 minutes on day 1 in Part B. On day 8 participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults ≥ 18 to ≤ 45 years of age upon entry into screening
- History of migraine headaches without aura for ≥ 6 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-II) (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report
- Migraine frequency: ≥ 1 and ≤ 5 migraine days per month in each of the 3 months prior to screening
Key exclusion criteria (3 listed)
- History of migraine with aura, cluster headache or hemiplegic migraine headache according to the IHS Classification ICHD-II (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report
- ≥ 6 migraine days per month in the last 3 months prior to study enrollment and during screening period
- Other headache disorders (except for episodic tension-type headache <5 days/month)
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 once on day 1 of Part B of the study by intravenous infusion. | Drug | Erenumab |
| PlaceboAdministered once on day 1 of Part B of the study by intravenous infusion. | Drug | Placebo |
| PACAP-38 Challenge AgentAlso: Pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38)Administered by intravenous infusion during Part A of the study for dose selection for Part B. Administered by intravenous infusion on day 8 in Part B as a challenge agent to induce a migraine-like attack. | Drug | Erenumab, PACAP-38 Challenge Agent, Placebo |
Primary outcome
Number of Participants With a MLA Within 24 Hours of Challenge Agent Infusion
Time frame: Part B randomization phase day 8 plus 24 hours.
On day 1 of the double-blind randomization phase participants received 140 mg intravenous erenumab over 30 minutes or matching placebo. On day 8, participants received 10 mol/kg/minute PACAP-38 over 10 minutes and were observed for 24 hours after PACAP-38 infusion. A MLA was defined as fulfilling 1 of the 2 criteria: 1. Headache with at least 2 of the following characteristics: unilateral location, pulsating quality, moderate or severe pain intensity, aggravated by/causing avoidance of routine physical activity. Additionally, during the headache at least 1 of the following: nausea and/or vomiting, photophobia or phonophobia. 2. Headache described as mimicking usual migraine attack treated with triptan.
21 secondary outcomes
Number of Participants With a Headache Within 24 Hours of Challenge Agent Infusion
Time frame: Part B randomization phase day 8 plus 24 hours.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Part B randomization phase day 1 until EOS (up to 12 weeks).
Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Day 1, Day 8 and EOS
Time frame: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).
Mean Change From Baseline in Heart Rate at Day 1, Day 8 and EOS
Time frame: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).
Mean Change From Baseline in Respiratory Rate at Day 1, Day 8 and EOS
Time frame: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).
Mean Change From Baseline in Temperature at Day 1, Day 8 and EOS
Time frame: Part B randomization phase baseline and day 1, day 8 and EOS (week 12).
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS
Time frame: Part B randomization phase baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Total Bilirubin at Day 8, Day 9 and EOS
Time frame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Blood Urea at Day 8, Day 9 and EOS
Time frame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Creatine Kinase at Day 8, Day 9 and EOS
Time frame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Creatinine at Day 8, Day 9 and EOS
Time frame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Direct Bilirubin at Day 8, Day 9 and EOS
Time frame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Eosinophil Count at Day 8, Day 9 and EOS
Time frame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Blood Glucose at Day 8, Day 9 and EOS
Time frame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Mean Change From Baseline in Hemoglobin A1C (Fraction of 1) at Day 8, Day 9 and EOS
Time frame: Part B randomization baseline and day 8, day 9 and EOS (week 12).
Pharmacokinetics (PK): Mean Erenumab Serum Concentration at 1 Hour (C1h)
Time frame: Part B randomization phase 1 hour post-dose day 1.
PK: Mean Area Under the Concentration-time Curve From Time 0 to 84 Days Post-dose (AUC84d)
Time frame: Part B randomization phase baseline and 84 days post-dose.
Number of Participants With Anti-Erenumab Antibodies
Time frame: Part B randomization phase baseline and EOS.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Part B randomization phase baseline and EOS.
Number of Participants With Clinically Significant Changes in Physical Parameters
Time frame: Part B randomization phase baseline and EOS.
Number of Participants With Clinically Significant Changes in Neurological Assessments
Time frame: Part B randomization phase baseline and EOS.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Erenumab and PACAP-38 Challenge Agent in people with Migraine, run by Amgen at 3 sites in 3 countries.
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 3 inclusion and 3 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 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Belgium, Netherlands. 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 3 Jun 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 a MLA Within 24 Hours of Challenge Agent Infusion (time frame: Part B randomization phase day 8 plus 24 hours.). 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 3 Jun 2019.