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Cluster HeadacheNCT03814226

PACAP-38 Infusion in Patients With Cluster Headache

A study testing Evaluation of headache inducing capabilities of PACAP38 in people with Cluster Headache, run by Danish Headache Center at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A randomized, double-blinded, two-way crossover study investigating the headache inducing capabilities of PACAP-38 in patients with cluster headache. Forty-five patients (15 episodic patients in cluster, 15, episodic patients in remission and 15 chronic cluster headache patients) are expected to participate. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cluster Headache
What is being tested?
Evaluation of headache inducing capabilities of PACAP38
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteDenmark
Study dates
1 Jan 2018to 5 May 2020
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Episodic or chronic cluster headache according to international classification of headache disorders
  • Age 18-65 years
  • Weight 50-100 kg
  • If women of childbearing potential, then must use safe contraceptives

Who cannot join

  • Episodic tension-type headache > 15 days per month
  • Other primary headache disorders, except tension-type headache < 5 days per month
  • Episodic cluster headache patients outside cluster must be completely headache free a minimum of 8 hours prior to experiment
  • Episodic cluster headache patients in cluster and chronic cluster headache patients must be completely headache free a minimum of 4 hours prior to experiment
  • Current or recent use (30 days) of injected or oral corticosteroids
  • Pregnant or lactating women
Show all 11Show fewer
  • A history or clinical signs of hypertension (BP > 150mmHg systolic / 100mmHg diastolic)
  • A history or clinical signs of hypotension (BP <90 mmHg systolic / 50mmHg diastolic)
  • A history of cardiovascular or cerebrovascular disease
  • A history of psychiatric disease or substance abuse
  • A medical history or clinical signs of disease that according to investigator would preclude participation in the study

Trial locations and contacts

1 site in 1 country.

Agneta Snoer, MD contact

+ 45 26274040

agneta.henriette.snoer.02@regionh.dk

Luise Vollsen, MD contact

+45 25732284

luisevollsen@gmail.com

Denmark1 site, 1 recruiting

  • Danish Headache Center

    Glostrup Municipality, 2620

    Agneta Snoer, MD, + 45 26274040, agneta.henriette.snoer.02@regionh.dk

    Anne Luise Vollesen, MD

    Recruiting

Other trials in Denmark

About this study

Official title: The Effect of PACAP-38 Infusion in Inducing Headache in Patients With Cluster Headache

A randomized, double-blinded, two-way crossover study investigating the headache inducing capabilities of PACAP-38 in patients with cluster headache. Forty-five patients (15 episodic patients in cluster, 15, episodic patients in remission and 15 chronic cluster headache patients) are expected to participate. Each patients will on two separate study days in a randomized way receive an infusion of PACAP-38 and VIP over 20 minutes followed by an observation period of 70 minutes. Blood samples for investigation of VIP, PACAP38; CGRP, NSE, Histamine and Tryptase will be drawn at fixed time-points during experiment.

Being tested
Evaluation of headache inducing capabilities of PACAP38
Medical subject headings
Cluster Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluation of headache inducing capabilities of PACAP38Other

    We wish to investigate the headache inducing capabilities of PACAP-38, a vasoactive peptide, over a 20 minute infusion. As PACAP-38 casues visible vasodilation, another vasoactive peptide, called VIP will be used as an active comparator.

Study groups in NCT03814226
Study groupRoleWhat they receive
PACAP-38 infusionExperimentalAccording to main hypothesis PACAP-38 is expected to induce headache. PACAP-38 causes marked vasodilation visible to investigator. PACAP38 (10 pmol/kg/min) is infused over 20 minutes, patients are observed before (15 minutes), during and after (70 minutes) infusion. Blood samples are drawn at fixed time-points.
Receives: Other: Evaluation of headache inducing capabilities of PACAP38
VIP infusionActive comparatorAccording to main hypothesis VIP is not expected to induce headache. VIP also causes marked vasodilation visible to investigator, which is why VIP is chosen as an active comparator. VIP (10 pmol/kg/min) is infused over 20 minutes. VIP is infused over 20 minutes, patients are observed before (15 minutes), during and after (70 minutes) infusion. Blood samples are drawn at fixed time-points.
Receives: Other: Evaluation of headache inducing capabilities of PACAP38

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Headache

    Difference in incidence of headache within 90 minutes of infusion between PACAP-38 infusion and VIP infusion

    Measured: 90 minutes

  2. Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE

    Changes in plasma/serum concentrations of the following markers after infusion of PACAP-38 and VIP: PACAP-38, VIP, CGRP, Histamine, Tryptase, NSE

    Measured: 90 minutes

  3. Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE after infusion

    Difference in plasma/serum concentrations of the following markers after infusion of PACAP-38 and VIP: PACAP-38, VIP, CGRP, Histamine, Tryptase, NSE between patients with induced cluster headache and patients without headache

    Measured: 90 minutes

  4. Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE at baseline

    Difference in plasma/serum concentrations of the following markers at baseline: PACAP-38, VIP, CGRP, Histamine, Tryptase, NSE between patients with episodic cluster headache in remission, episodic cluster headache in cluster, and chronic cluster headache

    Measured: 90 minutes

  5. Headache intensity

    Difference in AUD for headache intensity scores (0-90 minutes)

    Measured: 90 minutes

  6. Time to headache peak

    Difference in time to peak headache between PACAP-38 day and VIP day

    Measured: 90 minutes

Secondary outcomes (2)

  1. Change in mean arterial blood pressure

    Difference in area under the curve (AUC) for mean arterial pressure (based on systolic and diastolic measurements) and heart rate during experiment

    Measured: 90 minutes

  2. Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE

    Difference in serum/plasma levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE at baseline in patients who develop a cluster headache attack compared to those who do not

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2019
  2. Study start1 Jan 2018
  3. Primary completion1 Jan 2020 (estimated)
  4. Study completion5 May 2020 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03814226
Sponsor's protocol ID
H-17011569
Status last verified
Jan 2019
First submitted
15 Jan 2019
Last updated
23 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Deligianni C, Pellesi L, Chaudhry BA, Haulund Vollesen AL, Snoer AH, Hannibal J, Jensen RH, Ashina M. Plasma levels of VIP are not elevated during PACAP- and VIP-induced cluster headache attacks: an exploratory study. Front Neurol. 2023 Apr 18;14:1135246. doi: 10.3389/fneur.2023.1135246. eCollection 2023.

    PubMed 37143998

  • Pellesi L, Chaudhry BA, Vollesen ALH, Snoer AH, Baumann K, Skov PS, Jensen RH, Ashina M. PACAP38- and VIP-induced cluster headache attacks are not associated with changes of plasma CGRP or markers of mast cell activation. Cephalalgia. 2022 Jul;42(8):687-695. doi: 10.1177/03331024211056248. Epub 2021 Nov 25.

    PubMed 34822741

  • Vollesen ALH, Snoer A, Chaudhry B, Petersen AS, Hagedorn A, Hoffmann J, Jensen RH, Ashina M. The effect of pituitary adenylate cyclase-activating peptide-38 and vasoactive intestinal peptide in cluster headache. Cephalalgia. 2020 Nov;40(13):1474-1488. doi: 10.1177/0333102420940689. Epub 2020 Sep 22.

    PubMed 32962406

Questions about this trial

What is this clinical trial studying?

A study testing Evaluation of headache inducing capabilities of PACAP38 in people with Cluster Headache, 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 23 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Agneta Snoer, MD (+ 45 26274040, agneta.henriette.snoer.02@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Headache (time frame: 90 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03814226, which also lists 3 linked publications.

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 23 Jan 2019.

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