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CompletedNCT03471039Updated Jan 24, 2019

PACAP27 Headache Properties in Migraine Without Aura Patients

An interventional study of PACAP27 and Saline in Migraine Without Aura, sponsored by Danish Headache Center. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-24.

Sponsored by Danish Headache Center · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Aug 2017, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies in Migraine without Aura by Danish Headache Center — none open to participants now, none under way, none of them phase 3. Migraine without Aura · Danish Headache Center.

Enrollment
11th of 16
20 · median 28
Started
2017
the only one that year
No phase
15 of 18
none open now
Registered
8th of 18
by date

Among the 18 studies in Migraine without Aura by Danish Headache Center, this one is the 11th largest by enrollment of the 16 interventional ones that give a count, is the only one that started in 2017, is one of 15 with no phase, and was the 8th registered.

Migraine without Aura

109 studies on the registry are indexed under Migraine without Aura; 18 are open to participants now.

Browse Migraine without Aura studies →

Open to participants now

None of the 18 studies in Migraine without Aura by Danish Headache Center is open now.

Where they have run

Denmark17

Who these studies take

Of the 12 Migraine without Aura studies recruiting now, 5 (42%) set no upper age limit and 7 (58%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 18 studies in Migraine without Aura by Danish Headache Center as a file.
02

Study 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.

03

Conditions studied

  • Migraine Without Aura

Browse trials for

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 . Fertile women do not include hysterectomized women or women who are for at least 2 years. Safe contraception includes either Intra Uterine Device (IUD), birth control pills, surgical sterilization of the woman or depot progestogen.

Exclusion criteria

Exclusion Criteria:

  • 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 .
    • 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.
    • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Active

    PACAP-27

    Drug: PACAP27

  • Placebo comparator
    Placebo

    Saline

    Drug: Saline

Interventions

  • DrugPACAP27

    Infusion of PACAP27 over 20 minutes.

  • DrugSaline

    Infusion of Saline over 20 minutes.

06

What researchers measure

Primary outcomes

  1. Headache Scores

    Comparison between PACAP27 and Placebo

    Time frame: 0-12 hours

Secondary outcomes

  1. Facial blood flow (flushing)

    PACAP27 induces facial flushing compare to placebo measured by laser speckle contrast imaging

    Time frame: 0-120 mins

07

Study locations

1 site
  • Danish Headache Center
    Glostrup, 2600, Denmark
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in Aug 2018, 12 months.

Of 29 non-industry interventional studies with no phase under Migraine without Aura, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 34. This study's 12 months is below that.

Counting every sponsor, half of 33 studies reached it within 19 months; a quarter within 12 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2018
First posted
Mar 20, 2018
StartActual
Aug 30, 2017
Primary completionActual
Aug 30, 2018
CompletionActual
Sep 30, 2018
Last update
Jan 24, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03471039
Lead sponsor
Danish Headache Center
Responsible party
Hashmat Ghanizada (Principal Investigator, Danish Headache Center) — Principal investigator
First posted
Mar 20, 2018
Start date
Aug 30, 2017
Primary completion
Aug 30, 2018
Completion
Sep 30, 2018
Last update
Jan 24, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Pituitary Adenylate Cyclase-Activating Polypeptide

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