Headache, MigraineNCT04111484
Adrenomedullin Effect on Migraine Without Patients
A study testing Adrenomedullin and Saline in people with Headache, Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial summary
AM is a naturally occurring peptide in the body and consists of 52 amino acids. AM belongs to the calcitonin gene-related peptide (CGRP) superfamily and has several structural, physiological and pharmacological similarities to CGRP, intermdine and amylin. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- Adrenomedullin and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Sep 2019to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years old
- 50-100 kg
- migraine without aura according International Headache Classification Disorders 3rd edition
Who cannot join
- Tension-type headaches more than 5 days a month on average over the past year.
- All other primary headache forms.-
- Headache later than 48 hours before the start of the trial.
- Daily intake of medicines of all kinds except oral contraception.
- Taking any medicine later than 4 times the plasma half-life of that drug (on the day of the trial), except oral contraception.
- Pregnant or breastfeeding women.
Show all 15Show fewer
- Headache on the day of the trial or later than 48 hours before the administration of the trial drug / placebo
- Migraines within 3 days before the trial date.
- Anamnestic information or clinical signs (on the day of inclusion):
- Hypertension (systolic blood pressure> 150 mmHg and / or diastolic blood pressure> 100 mmHg)
- Hypotension (systolic blood pressure <90 mm Hg and / or diastolic blood pressure <50 mmHg)
- Cardiovascular diseases of all kinds, including cerebrovascular diseases.
- Anamnestic or clinical signs of mental illness or abuse.
- Patients with glaucoma or prostate hyperplasia
- Anamnestic or clinical signs of illness of any kind that the investigating physician considers relevant for participation in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adrenomedullins Headache Inducing Effects on Migraine Without Patients
AM is a naturally occurring peptide in the body and consists of 52 amino acids. AM belongs to the calcitonin gene-related peptide (CGRP) superfamily and has several structural, physiological and pharmacological similarities to CGRP, intermdine and amylin. In a randomized double-blind, placebo controlled cross-over design 20 migraine patients without aura recruited to receive infusion of adrenomedullin or placebo (saline).
Read the detailed description
AM is a naturally occurring peptide in the body and consists of 52 amino acids. AM belongs to the calcitonin gene-related peptide (CGRP) superfamily and has several structural, physiological and pharmacological similarities to CGRP, intermdine and amylin. In a randomized double-blind, placebo controlled cross-over design 20 migraine patients without aura recruited to receive infusion of adrenomedullin or placebo (saline).
A pilot study on healthy volunteers were conducted to determine tolerable dose of adrenomedullin to the main study.
- Conditions
- Headache, Migraine
- Being tested
- Adrenomedullin, Saline
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdrenomedullinOther
Adrenomedullin is a naturally found in the human body and has strong vasoactive properties.
SalineOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Adrenomedullin | Active comparator | Will received 19.9 picomol/kg/min of adrenomedullin over 20 min Receives: Other: Adrenomedullin |
| Saline | Placebo comparator | Saline Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine incidance after infusion of adrenomedullin compared to placebo
A standard headache questionnaire will be used to register headache intensity and migraine associated symptoms.
Measured: 0-12 hours
Secondary outcomes (2)
Headache intensity
Headache intensity will be measured using Visual analogue scale (0 = no pain -10 = worst pain )
Measured: 0-12 hours
Change in puls, MAP and facial flushing
After infusion of adrenomedullin compared to placebo
Measured: 0-90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start28 Sep 2019
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hashmat Ghanizada, MD, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111484
- Sponsor's protocol ID
- H-18020494
- Status last verified
- Feb 2020
- First submitted
- 26 Sep 2019
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghanizada H, Al-Karagholi MA, Arngrim N, Morch-Rasmussen M, Walker CS, Hay DL, Ashina M. Effect of Adrenomedullin on Migraine-Like Attacks in Patients With Migraine: A Randomized Crossover Study. Neurology. 2021 May 18;96(20):e2488-e2499. doi: 10.1212/WNL.0000000000011930. Epub 2021 Apr 7.
PubMed 33827963
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenomedullins Headache Inducing Effects on Migraine Without Patients
- ClinicalTrials.gov ID
- NCT04111484
- Acronym / sponsor ID
- H-18020494
- Conditions
- Headache, Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 28 Sep 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AM is a naturally occurring peptide in the body and consists of 52 amino acids. AM belongs to the calcitonin gene-related peptide (CGRP) superfamily and has several structural, physiological and pharmacological similarities to CGRP, intermdine and amylin. In a randomized double-blind, placebo controlled cross-over design 20 migraine patients without aura recruited to receive infusion of adrenomedullin or placebo (saline).
Detailed description
AM is a naturally occurring peptide in the body and consists of 52 amino acids. AM belongs to the calcitonin gene-related peptide (CGRP) superfamily and has several structural, physiological and pharmacological similarities to CGRP, intermdine and amylin. In a randomized double-blind, placebo controlled cross-over design 20 migraine patients without aura recruited to receive infusion of adrenomedullin or placebo (saline).
A pilot study on healthy volunteers were conducted to determine tolerable dose of adrenomedullin to the main study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adrenomedullin | Active comparator | Other: AdrenomedullinWill received 19.9 picomol/kg/min of adrenomedullin over 20 min |
| Saline | Placebo comparator | Other: SalineSaline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-60 years old
- 50-100 kg
- migraine without aura according International Headache Classification Disorders 3rd edition
Key exclusion criteria (15 listed)
- Tension-type headaches more than 5 days a month on average over the past year.
- All other primary headache forms.-
- Headache later than 48 hours before the start of the trial.
- Daily intake of medicines of all kinds except oral contraception.
- Taking any medicine later than 4 times the plasma half-life of that drug (on the day of the trial), except oral contraception.
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 |
|---|---|---|
| AdrenomedullinAdrenomedullin is a naturally found in the human body and has strong vasoactive properties. | Other | Adrenomedullin |
| SalinePlacebo | Other | Saline |
Primary outcome
Migraine incidance after infusion of adrenomedullin compared to placebo
Time frame: 0-12 hours
A standard headache questionnaire will be used to register headache intensity and migraine associated symptoms.
2 secondary outcomes
Headache intensity
Time frame: 0-12 hours
Change in puls, MAP and facial flushing
Time frame: 0-90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Derived from this study: PubMed 33827963Ghanizada H, Al-Karagholi MA, Arngrim N, Morch-Rasmussen M, Walker CS, Hay DL, Ashina M. Effect of Adrenomedullin on Migraine-Like Attacks in Patients With Migraine: A Randomized Crossover Study. Neurology. 2021 May 18;96(20):e2488-e2499. doi: 10.1212/WNL.0000000000011930. Epub 2021 Apr 7.
- Individual participant dataSharing planned: No
Related trials for Headache, Migraine
Recruiting
Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain
Migraine, Migraine in Adolescence
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adrenomedullin and Saline in people with Headache, Migraine, run by Danish Headache Center at 1 site in Denmark.
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 15 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 2 Mar 2020. 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 Denmark. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Migraine incidance after infusion of adrenomedullin compared to placebo (time frame: 0-12 hours). 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 NCT04111484, which also lists 1 linked publication.
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 2 Mar 2020.