Migraine Without AuraNCT01471990
Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance
A study testing Pituitary Adenylate Cyclase-Activating Polypeptide-38 and Vasoactive Intestinal Peptide in people with Migraine Without Aura, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to examine and compare the effect of pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal polypeptide (VIP) on intracranial arteries and neuronal activity in patients with migraine without aura using a high resolution magnetic resonance imaging (MRI)… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Migraine Without Aura
- What is being tested?
- Pituitary Adenylate Cyclase-Activating Polypeptide-38 and Vasoactive Intestinal Peptide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- May 2011to Jun 2012
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy migraine patient without aura
- Age 18-40
- Weight 50-100 kg
- Fertile women must use safe contraceptives
Who cannot join
- Tension type headache more than 5 days per month
- Other primary headaches
- Daily use of medication except contraceptives
- Drug taken within 4 times the half life for the specific drug except contraceptives
- Pregnant or lactating women
- Exposure to radiation within the last year
Show all 12Show fewer
- Hypotension or hypertension
- Cardiovascular or cerebrovascular disease
- Mental illness or substance abuse
- Other significant conditions determined by the examining doctor
- Contraindications to MRI scan
- Headache within the last 48 hours before start of trial
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen
Glostrup Municipality, DK-2600
About this study
Official title: The Effect of PACAP38 and VIP on Migraine Patients Assessed by a 3-Tesla MR Scanner
The purpose of this study is to examine and compare the effect of pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal polypeptide (VIP) on intracranial arteries and neuronal activity in patients with migraine without aura using a high resolution magnetic resonance imaging (MRI), including MR angiography (MRA) and functional MRI (fMRI).
MRA will be used to detect changes in intracranial artery circumferences before and after PACAP38 and VIP.
Read more
fMRI will be used oo detect changes in blood-oxygenation-level-dependent-signal (BOLD-signal).
PACAP38 but not VIP induces migraine like attacks in migraine patients. The migraine specific drug sumatriptan will be given to relieve pain and the effect will also be registered using MRA and fMRI.
- Conditions
- Migraine Without Aura
- Being tested
- Pituitary Adenylate Cyclase-Activating Polypeptide-38, Vasoactive Intestinal Peptide
- Keywords
- PACAP38, MMA, migraine, angiography, VIP, vasodilatation
- Medical subject headings
- Migraine without Aura, Migraine Disorders, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pituitary Adenylate Cyclase-Activating Polypeptide-38Drug
10 pmol/kg/min over 20 mins
Vasoactive Intestinal PeptideDrug
8 pmol/kg/min over 20 mins
| Study group | Role | What they receive |
|---|---|---|
| PACAP38 | Active comparator | Not described Receives: Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38 |
| VIP | Active comparator | Not described Receives: Drug: Vasoactive Intestinal Peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between PACAP38 and VIP induced changes in intracranial artery circumference before and after infusions
Measured: Baseline, 20 minutes, 2 hours and 5 hours
Secondary outcomes (4)
Headache scores
hospital and post hospital phase
Measured: 24 hours
Comparison between PACAP38 and VIP induced changes in BOLD response
Measured: 5 hours
Change in intracranial artery circumference before and after injection of sumatriptan
Measured: 5 hours
Comparison between PACAP38 and VIP induced changes in brain structure
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2012
- Study completionJun 2012
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, University Hospital, Gentofte, Copenhagen, Lundbeck Foundation, Cool Sorption Foundation of 1988
- Responsible party
- Principal investigator, Faisal Mohammad Amin, Glostrup University Hospital, Copenhagen
- Investigators
- Faisal Amin, M.D., Principal investigator, Danish Headache Centre and Department of Neurology, Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471990
- Sponsor's protocol ID
- H-1-2011-023
- Status last verified
- Aug 2012
- First submitted
- 9 Nov 2011
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of PACAP38 and VIP on Migraine Patients Assessed by a 3-Tesla MR Scanner
- ClinicalTrials.gov ID
- NCT01471990
- Acronym / sponsor ID
- H-1-2011-023
- Conditions
- Migraine Without Aura
- Keywords
- PACAP38, MMA, migraine, angiography, VIP, vasodilatation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, University Hospital, Gentofte, Copenhagen, Lundbeck Foundation, Cool Sorption Foundation of 1988
- Study start
- May 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Nov 2011 (estimated)
- 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.
The purpose of this study is to examine and compare the effect of pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal polypeptide (VIP) on intracranial arteries and neuronal activity in patients with migraine without aura using a high resolution magnetic resonance imaging (MRI), including MR angiography (MRA) and functional MRI (fMRI).
MRA will be used to detect changes in intracranial artery circumferences before and after PACAP38 and VIP.
fMRI will be used oo detect changes in blood-oxygenation-level-dependent-signal (BOLD-signal).
PACAP38 but not VIP induces migraine like attacks in migraine patients. The migraine specific drug sumatriptan will be given to relieve pain and the effect will also be registered using MRA and fMRI.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACAP38 | Active comparator | Drug: Pituitary Adenylate Cyclase-Activating Polypeptide-38 |
| VIP | Active comparator | Drug: Vasoactive Intestinal Peptide |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy migraine patient without aura
- Age 18-40
- Weight 50-100 kg
- Fertile women must use safe contraceptives
Key exclusion criteria (12 listed)
- Tension type headache more than 5 days per month
- Other primary headaches
- Daily use of medication except contraceptives
- Drug taken within 4 times the half life for the specific drug except contraceptives
- Pregnant or lactating women
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 |
|---|---|---|
| Pituitary Adenylate Cyclase-Activating Polypeptide-3810 pmol/kg/min over 20 mins | Drug | PACAP38 |
| Vasoactive Intestinal Peptide8 pmol/kg/min over 20 mins | Drug | VIP |
Primary outcome
Comparison between PACAP38 and VIP induced changes in intracranial artery circumference before and after infusions
Time frame: Baseline, 20 minutes, 2 hours and 5 hours
4 secondary outcomes
Headache scores
Time frame: 24 hours
Comparison between PACAP38 and VIP induced changes in BOLD response
Time frame: 5 hours
Change in intracranial artery circumference before and after injection of sumatriptan
Time frame: 5 hours
Comparison between PACAP38 and VIP induced changes in brain structure
Time frame: 5 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 29 Aug 2012.
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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.
Faisal Amin, M.D. principal investigator
Danish Headache Centre and Department of Neurology, Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pituitary Adenylate Cyclase-Activating Polypeptide-38 and Vasoactive Intestinal Peptide in people with Migraine Without Aura, run by Glostrup University Hospital, Copenhagen 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 4 inclusion and 12 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 29 Aug 2012. 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?
Comparison between PACAP38 and VIP induced changes in intracranial artery circumference before and after infusions (time frame: Baseline, 20 minutes, 2 hours and 5 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 29 Aug 2012.