"Migraine-like" HeadacheNCT01384812
Prostaglandin E2 in Migraine Suffers Without Aura.
A study testing dinoprostone and isoton sodium chloride in people with "Migraine-like" Headache, run by Troels Wienecke at 1 site in Denmark.
Trial summary
The hypothesis of this study is that Prostaglandin E2 (PGE2) induces headache and dilatation of brain vessels in migraine patients without aura. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- "Migraine-like" Headache
- What is being tested?
- dinoprostone and isoton sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Jul 2011
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with migraine without aura
Who cannot join
- Tension type headache more than x 3 per month
- Other forms for primary headache
- Headache 24 h before the day of the investigation
- Migraine 48 h before the day of the investigation
- Hypertension
- Hypotension
Show all 12Show fewer
- Pregnant/nursing
- Daily intake of medication (except oral contraceptives and migraine rescue medicine during migraine attack)
- Cardiovascular or central nervous system (CNS) disease
- Drug/alcohol abuse
- Psychiatric disease
- Asthma or any other lung diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin E2 in Migraine Suffers Without Aura.
The hypothesis of this study is that Prostaglandin E2 (PGE2) induces headache and dilatation of brain vessels in migraine patients without aura.
- Conditions
- "Migraine-like" Headache
- Being tested
- dinoprostone, isoton sodium chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dinoprostoneDrug
Also called Prostin E2
intravenous injection 0.4 μgr/kg/min for 25 min
isoton sodium chlorideDrug
Also called placebo
intravenous injection for 25 min
| Study group | Role | What they receive |
|---|---|---|
| Isoton sodium chloride | Placebo comparator | Not described Receives: Drug: isoton sodium chloride |
| Prostin E2 (dinoprostone) | Active comparator | Not described Receives: Drug: dinoprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache score on a 10-point verbal rating scale (VRS).
Incidence of headache 0 indicated no headache; 1 indicated a different sensation, pounding or throbbing, but not necessarily painful; 5 indicated moderate headache and 10 indicated worst imaginable headache.
Measured: 24 h
Secondary outcomes (7)
Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz).
Changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
Measured: 90 min
Diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan.
Changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
Measured: 90 min
Mean arterial blood pressure (MAP).
Changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
Measured: 90 min
Electrocardiography (ECG).
Changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
Measured: 90 min
Heart rate (HR).
Changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
Measured: 90 min
End-tidal partial pressure of pCO2 (PetCO2).
Changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
Measured: 90 min
Transcutaneous arterial oxygen saturation (SAT)
Changes from base line recorded every 10th min. until time 90 min on day 1 and day 2. The infusion takes 25 min from time 0.
Measured: 90 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for "Migraine-like" HeadacheStudies 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Troels Wienecke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Troels Wienecke, Danish Headache Center
- Investigators
- Troels Wienecke, MD,PhD, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384812
- Sponsor's protocol ID
- DHC-PGE2-2011
- Status last verified
- Nov 2011
- First submitted
- 20 Jun 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of Prostaglandin E2 in Migraine Suffers Without Aura.
- ClinicalTrials.gov ID
- NCT01384812
- Acronym / sponsor ID
- DHC-PGE2-2011
- Conditions
- "Migraine-like" Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Troels WieneckeUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 29 Jun 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 hypothesis of this study is that Prostaglandin E2 (PGE2) induces headache and dilatation of brain vessels in migraine patients without aura.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isoton sodium chloride | Placebo comparator | Drug: isoton sodium chloride |
| Prostin E2 (dinoprostone) | Active comparator | Drug: dinoprostone |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with migraine without aura
Key exclusion criteria (12 listed)
- Tension type headache more than x 3 per month
- Other forms for primary headache
- Headache 24 h before the day of the investigation
- Migraine 48 h before the day of the investigation
- Hypertension
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 |
|---|---|---|
| dinoprostoneAlso: Prostin E2intravenous injection 0.4 μgr/kg/min for 25 min | Drug | Prostin E2 (dinoprostone) |
| isoton sodium chlorideAlso: placebointravenous injection for 25 min | Drug | Isoton sodium chloride |
Primary outcome
Headache score on a 10-point verbal rating scale (VRS).
Time frame: 24 h
Incidence of headache 0 indicated no headache; 1 indicated a different sensation, pounding or throbbing, but not necessarily painful; 5 indicated moderate headache and 10 indicated worst imaginable headache.
7 secondary outcomes
Blood flow velocity in the middle cerebral artery (VMCA) measured by a Transcranial Doppler (TCD) ultrasonography (2MHz).
Time frame: 90 min
Diameter of superficial temporal artery and radial artery measured by a high resolution ultrasound scanner, C-scan.
Time frame: 90 min
Mean arterial blood pressure (MAP).
Time frame: 90 min
Electrocardiography (ECG).
Time frame: 90 min
Heart rate (HR).
Time frame: 90 min
End-tidal partial pressure of pCO2 (PetCO2).
Time frame: 90 min
Transcutaneous arterial oxygen saturation (SAT)
Time frame: 90 min
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 9 Nov 2011.
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.
Troels Wienecke, MD,PhD principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dinoprostone and isoton sodium chloride in people with "Migraine-like" Headache, run by Troels Wienecke 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 1 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 9 Nov 2011. 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?
Headache score on a 10-point verbal rating scale (VRS). (time frame: 24 h). 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 9 Nov 2011.