Migraine Without AuraNCT03598075
Amylin and CGRP Head to Head Provocation in Migraine Without Aura Patients
A study testing Amylin (Pramlintide) and CGRP in people with Migraine Without Aura, run by Danish Headache Center at 1 site in Denmark.
Trial summary
Amylin and calcitonin gene related peptide (CGRP) are related to the same peptide family. Both share 16 out of 37 amino acids and can activate each others receptor. CGRP is implicated in migraine pathophysiology but the role of Amylin and its receptor in migraine is not fully clarified. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Without Aura
- What is being tested?
- Amylin (Pramlintide) and CGRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2018to 31 Dec 2019
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Migraine patients meeting International Headache Society (IHS) criteria for migraine without aura of both sexes, 18-60 year, 50-100 kg.
- Fertile women should use safe contraception. Fertile women do not include hysterectomized women or women who are postmenopausal for at least 2 years. Safe contraception includes either Intra Uterine Device (IUD), birth control pills, surgical sterilization of the woman or depot progestogen.
Who cannot join
- Tension Type headache for more than 5 days the month on average in the last year.
- All other primary headaches .
- Headache later than 48 hours before trial start.
- Daily intake of any medicine other than oral contraception.
- Ingestion of any form of medicinal product later than 4 times the plasma half-life substance (on trial day), except for oral contraception.
- Pregnant or breastfeeding women.
Show all 15Show fewer
- Headache on the test day or later than 48 hours prior to administration of trial medicine / placebo
- Migraine within 5 days before the trial date.
- Ancestral information or clinical signs of (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 disease of all kinds, including cerebrovascular disease.
- Anamnestic or clinical signs of mental illness or abuse.
- Patients with glaucoma or prostatic hyperplasia
- Anamnestic or clinical signs of diseases of any kind such as the investigating physician is considered relevant for participation in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Amylin and CGRP Migraine Provocation in Migraine Without Aura Patients
Amylin and calcitonin gene related peptide (CGRP) are related to the same peptide family. Both share 16 out of 37 amino acids and can activate each others receptor. CGRP is implicated in migraine pathophysiology but the role of Amylin and its receptor in migraine is not fully clarified.
Read the detailed description
Amylin is a peptide hormone that binds to a G-protein coupled receptor (GPCR). amylin was originally found in the pancreas (Beta Cell of Islets of Langerhans) but also shown to be present in the trigeminal ganglion, hind horn ganglia and perivascular nerve fibers.
Amylin has many similarities with CGRP. Amylin and CGRP share 16 out 37 amino acids. Both peptides can activate the amylin 1 subtype (AMY1)receptor with high affinity and reported to have more similar physiological and pharmacological effects.
In addition, both peptides increase the intracellular concentration of cyclic AMP (cAMP) which has a central role in migraine pathophysiology.
The aim of the study is pin point the role of amylin and amylin receptor compare to CGRP in migraine pathophysiology.
- Conditions
- Migraine Without Aura
- Being tested
- Amylin (Pramlintide), CGRP
- Medical subject headings
- Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amylin (Pramlintide)Other
Pramlintide is a amylin analog. It will be given intravenously at the rate of 120 micrograms over 20 minutes .
CGRPOther
CGRP It will be given intravenously at the rate of 30 microgram over 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Amylin (Pramlintide) | Other | Pramlintide intravenous infusion 120 micrograms over 20 minutes Receives: Other: Amylin (Pramlintide) |
| CGRP | Other | CGRP intravenous infusion 30 micrograms over 20 minutes Receives: Other: CGRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine incidence
Before (-10 min) and after infusion (+12 hours) of amlyin compared with before and after infusion of CGRP based on questionnaire reported headache and associated symptoms
Measured: 12 hours
Secondary outcomes (4)
Dilatation of Arteria radialis and arteria temporalis superficialis
Dermascan will be used to measure the above mentioned Radial and temporal arteries diameter.
Measured: 2 hours
Facial flushing
Flushing will measured by laser contrast imaging
Measured: 2 hours
Plasma blood samples
Measumrent of amylin and CGRP peptides in the plasma in picomol/L
Measured: 2 hours
Headache intensity
Measured by visual analog score (VAS) ( 0 to 10). Change in area under curve (AUC)
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jul 2018
- Primary completion30 Sep 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine Without AuraStudies 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
- Model description
- In a Randomized, double blind, cross over experiment. Migraine without aura patients will received amylin or CGRP in two separate days apart by a week.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 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
- NCT03598075
- Sponsor's protocol ID
- H-17035931
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2018
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amylin and CGRP Migraine Provocation in Migraine Without Aura Patients
- ClinicalTrials.gov ID
- NCT03598075
- Acronym / sponsor ID
- H-17035931
- Conditions
- Migraine Without Aura
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Jul 2018 (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.
Amylin and calcitonin gene related peptide (CGRP) are related to the same peptide family. Both share 16 out of 37 amino acids and can activate each others receptor. CGRP is implicated in migraine pathophysiology but the role of Amylin and its receptor in migraine is not fully clarified.
Detailed description
Amylin is a peptide hormone that binds to a G-protein coupled receptor (GPCR). amylin was originally found in the pancreas (Beta Cell of Islets of Langerhans) but also shown to be present in the trigeminal ganglion, hind horn ganglia and perivascular nerve fibers.
Amylin has many similarities with CGRP. Amylin and CGRP share 16 out 37 amino acids. Both peptides can activate the amylin 1 subtype (AMY1)receptor with high affinity and reported to have more similar physiological and pharmacological effects.
In addition, both peptides increase the intracellular concentration of cyclic AMP (cAMP) which has a central role in migraine pathophysiology.
The aim of the study is pin point the role of amylin and amylin receptor compare to CGRP in migraine pathophysiology.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- In a Randomized, double blind, cross over experiment. Migraine without aura patients will received amylin or CGRP in two separate days apart by a week.
| Arm | Type | Receives |
|---|---|---|
| Amylin (Pramlintide) | Other | Other: Amylin (Pramlintide)Pramlintide intravenous infusion 120 micrograms over 20 minutes |
| CGRP | Other | Other: CGRPCGRP intravenous infusion 30 micrograms over 20 minutes |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Migraine patients meeting International Headache Society (IHS) criteria for migraine without aura of both sexes, 18-60 year, 50-100 kg.
- Fertile women should use safe contraception. Fertile women do not include hysterectomized women or women who are postmenopausal for at least 2 years. Safe contraception includes either Intra Uterine Device (IUD), birth control pills, surgical sterilization of the woman or depot progestogen.
Key exclusion criteria (15 listed)
- Tension Type headache for more than 5 days the month on average in the last year.
- All other primary headaches .
- Headache later than 48 hours before trial start.
- Daily intake of any medicine other than oral contraception.
- Ingestion of any form of medicinal product later than 4 times the plasma half-life substance (on trial day), except for 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 |
|---|---|---|
| Amylin (Pramlintide)Pramlintide is a amylin analog. It will be given intravenously at the rate of 120 micrograms over 20 minutes . | Other | Amylin (Pramlintide) |
| CGRPCGRP It will be given intravenously at the rate of 30 microgram over 20 minutes. | Other | CGRP |
Primary outcome
Migraine incidence
Time frame: 12 hours
Before (-10 min) and after infusion (+12 hours) of amlyin compared with before and after infusion of CGRP based on questionnaire reported headache and associated symptoms
4 secondary outcomes
Dilatation of Arteria radialis and arteria temporalis superficialis
Time frame: 2 hours
Facial flushing
Time frame: 2 hours
Plasma blood samples
Time frame: 2 hours
Headache intensity
Time frame: 12 hours
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 25 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Migraine Without Aura
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
RecruitingPhase 2
Study of EVO756 in Adults With Migraine
Migraine
RecruitingPhase 3
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Pediatric Migraine
RecruitingPhase 3
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Acute Treatment of Migraine
RecruitingPhase 1
A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department
Migraine, Migraine Disease
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 Amylin (Pramlintide) and CGRP in people with Migraine Without Aura, 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 2 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 25 Jun 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. 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 incidence (time frame: 12 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 25 Jun 2020.