Migraine Without AuraNCT02364453
The Effect of Histamine H1 Receptor Antagonist, Clemastin, on PACAP38 Induced Headache in Migraine Patients
A study testing PACAP38 in people with Migraine Without Aura, run by Song Guo at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the effects of antihistamine (Clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as on biochemical markers for mast cell degranulation in migraine patients. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Migraine Without Aura
- What is being tested?
- PACAP38
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2015to Apr 2016
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- migraine patients fulfilling IHS criteria for migraine without aura, ages 18-50, 50-100 kg, fertile women must be using safe prevention
Who cannot join
- other types of primary headache than migraine
- headache on trial day or later than 48 hours before trial day
- migraine up to three days before trial day
- any type of cardiovascular disease
- clinical signs or patient history of any type of illness that the medical doctor in charge of trials deems relevant for participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Headache Center & Department of Neurology
Copenhagen, Glostrup, 2600
About this study
The purpose of this study is to determine the effects of antihistamine (Clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages than previously investigated. As this has never been done before it is unknown how a lower dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.
Our three hypotheses are:
- Pre-treatment with Clemastin reduces PACAP38 sensitivity and inhibits development of migraine in migraine patients.
- Clemastin inhibits the increase in plasma concentration of TNF-alpha, histamine and tryptase after PACAP38-infusion.
- PACAP38 in lower dosages (4, 6 and 8 pmol/kg/min) induces migraine in migraine patients.
Read the detailed description
The purpose of this study is to determine the effects of antihistamine (Clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages than previously investigated. As this has never been done before it is unknown how a lower dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.
- Conditions
- Migraine Without Aura
- Being tested
- PACAP38
- 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.
PACAP38Drug
Also called Pituitary Adenylate Cyclase Activating Peptide 38
Giving doses of 4, 6 or 8 pg/kg/min on three separate trial days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo to PACAP38 | Experimental | Pre-treatment with placebo. PACAP38 8pmol/kg/min Receives: Drug: PACAP38 |
| Clemastin 1 mg/ml to PACAP38 8pmol/kg/min | Experimental | Pre-treatment with Clemastin 1 mg/ml PACAP38 8 pmol/kg/min Receives: Drug: PACAP38 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of migraine in migraine patients
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2016
- Study completionApr 2016
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Song Guo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Song Guo, Danish Headache Center
- Investigators
- Messoud Ashina, Professor, Study director, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364453
- Sponsor's protocol ID
- H-4-2014-103
- Status last verified
- Feb 2018
- First submitted
- 7 Oct 2014
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Histamine H1 Receptor Antagonist, Clemastin, on PACAP38 Induced Headache in Migraine Patients
- ClinicalTrials.gov ID
- NCT02364453
- Acronym / sponsor ID
- H-4-2014-103
- Conditions
- Migraine Without Aura
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Song GuoUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 18 Feb 2015 (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 determine the effects of antihistamine (Clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages than previously investigated. As this has never been done before it is unknown how a lower dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.
Our three hypotheses are:
- Pre-treatment with Clemastin reduces PACAP38 sensitivity and inhibits development of migraine in migraine patients.
- Clemastin inhibits the increase in plasma concentration of TNF-alpha, histamine and tryptase after PACAP38-infusion.
- PACAP38 in lower dosages (4, 6 and 8 pmol/kg/min) induces migraine in migraine patients.
Detailed description
The purpose of this study is to determine the effects of antihistamine (Clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (PACAP38) as well as on biochemical markers for mast cell degranulation in migraine patients. Also, to investigate the occurrence of migraine in migraine patients after infusion of PACAP38 in lower dosages than previously investigated. As this has never been done before it is unknown how a lower dose of PACAP38 will affect 1) the incidence of migraine attacks, 2) the accompanying symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo to PACAP38 | Experimental | Drug: PACAP38Pre-treatment with placebo. PACAP38 8pmol/kg/min |
| Clemastin 1 mg/ml to PACAP38 8pmol/kg/min | Experimental | Drug: PACAP38Pre-treatment with Clemastin 1 mg/ml PACAP38 8 pmol/kg/min |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- migraine patients fulfilling IHS criteria for migraine without aura, ages 18-50, 50-100 kg, fertile women must be using safe prevention
Key exclusion criteria (5 listed)
- other types of primary headache than migraine
- headache on trial day or later than 48 hours before trial day
- migraine up to three days before trial day
- any type of cardiovascular disease
- clinical signs or patient history of any type of illness that the medical doctor in charge of trials deems relevant for participation
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 |
|---|---|---|
| PACAP38Also: Pituitary Adenylate Cyclase Activating Peptide 38Giving doses of 4, 6 or 8 pg/kg/min on three separate trial days. | Drug | Clemastin 1 mg/ml to PACAP38 8pmol/kg/min, Placebo to PACAP38 |
Primary outcome
Development of migraine in migraine patients
Time frame: Up to 12 months
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 15 Feb 2018.
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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.
Messoud Ashina, Professor study director
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 PACAP38 in people with Migraine Without Aura, run by Song Guo 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 5 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 15 Feb 2018. 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?
Development of migraine in migraine patients (time frame: Up to 12 months). 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 15 Feb 2018.