Migraine Without AuraNCT03471039
PACAP27 Headache Properties in Migraine Without Aura Patients
A study testing PACAP27 and Saline in people with Migraine Without Aura, run by Danish Headache Center at 1 site in Denmark.
Trial summary
Pituitary adenylate cyclase-activating polypeptide (PACAP) is a signaling molecule, localized in sensory and parasympathetic perivascular nerves fibres. PACAP exists i to functional iso-forms Pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and PACAP27. 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?
- PACAP27 and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Aug 2017to 30 Sep 2018
- 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: Pituitary Adenylate Cyclase-activating Polypeptide (PACAP27) Headache Properties in Migraine Without Aura Patients
Pituitary adenylate cyclase-activating polypeptide (PACAP) is a signaling molecule, localized in sensory and parasympathetic perivascular nerves fibres. PACAP exists i to functional iso-forms Pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and PACAP27.
- Conditions
- Migraine Without Aura
- Being tested
- PACAP27, Saline
- 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.
PACAP27Drug
Infusion of PACAP27 over 20 minutes.
SalineDrug
Infusion of Saline over 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | PACAP-27 Receives: Drug: PACAP27 |
| Placebo | Placebo comparator | Saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Scores
Comparison between PACAP27 and Placebo
Measured: 0-12 hours
Secondary outcomes (1)
Facial blood flow (flushing)
PACAP27 induces facial flushing compare to placebo measured by laser speckle contrast imaging
Measured: 0-120 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start30 Aug 2017
- Primary completion30 Aug 2018
- Study completion30 Sep 2018
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
- Health services research
- 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, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471039
- Sponsor's protocol ID
- H-17016232
- Status last verified
- Jan 2019
- First submitted
- 1 Mar 2018
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pituitary Adenylate Cyclase-activating Polypeptide (PACAP27) Headache Properties in Migraine Without Aura Patients
- ClinicalTrials.gov ID
- NCT03471039
- Acronym / sponsor ID
- H-17016232
- Conditions
- Migraine Without Aura
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 20 Mar 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.
Pituitary adenylate cyclase-activating polypeptide (PACAP) is a signaling molecule, localized in sensory and parasympathetic perivascular nerves fibres. PACAP exists i to functional iso-forms Pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and PACAP27.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: PACAP27PACAP-27 |
| Placebo | Placebo comparator | Drug: SalineSaline |
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.
Key exclusion criteria (15 listed)
- Tension Type headache for more than 5 days the month on average in the last year.
- 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)
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 |
|---|---|---|
| PACAP27Infusion of PACAP27 over 20 minutes. | Drug | Active |
| SalineInfusion of Saline over 20 minutes. | Drug | Placebo |
Primary outcome
Headache Scores
Time frame: 0-12 hours
Comparison between PACAP27 and Placebo
1 secondary outcome
Facial blood flow (flushing)
Time frame: 0-120 mins
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 24 Jan 2019.
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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.
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 PACAP27 and Saline 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 24 Jan 2019. 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 Scores (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?
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 24 Jan 2019.