- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05750446
Effect of Riocigaut on Migraine Attack Induction and Cerebral Vasodilation in Migraine Patients.
Riociguat (BAY 63-2521), a Stimulator of Soluble Guanylate Cyclase (sGC) - Migraine Induction and Cerebral Vasodilation in Migraine Patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators believe that activation of sGC could play a role in migraine pathophysiology and propose that stimulation with riociguat causes migraine attacks alongside cranial arterial dilation in patients with migraine.
Twenty-one patients with migraine will participate at a screening visit and, if eligible, on two separate study days, where participants, in a randomized cross-over fashion, will ingest either riociguat (active comparator arm) or placebo (placebo comparator arm), serving as their own controls. On the two separate study days the investigators will measure change in diameter of superficial temporal artery and middle cerebral artery blood flow velocity, heart rate, blood pressure and register possible headache/migraine including associated symptoms until 6 hours after intake of riociguat or placebo. At home participants are expected to fill out a headache diary until 12 hours from intake of riociguat or placebo.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Messoud Ashina, MD, Ph.D., DMSc.
- Phone Number: +45-38633054
- Email: messoud.ashina@regionh.dk
Study Locations
-
-
Glostrup
-
Copenhagen, Glostrup, Denmark, 2600
- Danish Headache Center
-
Contact:
- Nadja B Rasmussen
- Phone Number: +4538633557
- Email: nadja.bredo.rasmussen@regionh.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A history of migraine without aura for ≥ 12 months according to the classification criteria of the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria.
- Ability to provide written informed consent and receive participant privacy and rights information prior to initiation of any study-specific activities.
- Male or female participants aged 18-45 years at screening.
- No migraine preventive treatment at screening or during study conduction.
- Non-smokers
Exclusion Criteria:
- Any current or previous history of other primary or secondary headache disorder(s) apart from tension type headache ≤ 5 days per month.
- Lack of ability to differentiate migraine from other headaches
- Headache within 24 hours before any study related procedures (Provocation Day 1 and Provocation Day 2) - Subjects are however allowed to be re-booked for provocation days according to allowed timelines.
- Any daily medication apart from contraceptives.
- Use of any antihypertensive, nitrates or nitric oxide donors or phosphodiesterase inhibitors, CYP3A4 and P-glycoprotein inhibitors, HIV-proteaseinhibitors, ciclosporin A or CYP1A1-inhibitors, antacida and acid-neutreulizing agents (such as aluminium-/magnesiumhydroxid), CYP3A4-inductors (such as bosentan, phenytoin, carbamazepin, phenobarbital and herbal remedies with perikon).
- Intake of any pro necessitate medication later than 4 times plasma half-life for the specific drug before study start.
- Women of child-bearing potential not currently using safe contraceptives. Women of child-bearing potential does not include hysterectomized women and women who have been in menopause for at least 2 years. Safe contraceptives include either IUD, birth control pills, surgical sterilization of the woman, depositary gestagen, barrier prevention or sexual abstinence.
- Pregnant or breastfeeding women
- Positive pregnancy urine screening on screening day or provocation days.
A medical history or clinical signs of
- Hypertension (systolic blood pressure >150mmHg and/or diastolic blood pressure >100mmHg)
- Hypotension (systolic blood pressure <100mmHg and/or diastolic blood pressure <50mmHg)
- Electrocardiogram (ECG) with any clinically significant abnormalities at screening determined by the investigator, including but not limited to, prolonged PQ or QTc interval, signs of arrythmias, ischemia or left/right ventricle dysfunction/hypertrophy.
- A medical history or clinical signs of pulmo-/cardiovascular disease including cerebrovascular disease.
- A family history of severe cardiac disease.
- A medical history or clinical signs of clinically significant psychiatric illness per investigator opinion.
- The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior.
- A medical history or clinical signs of substance or alcohol abuse
- A medical history or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion.
- Any history of hypersensitivity to riociguat.
- Subjects who do not want information about crucial pathological findings during the study
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or comply with all required study procedures to the best of the subject and study investigator's knowledge.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Riociguat / Placebo
Riociguat or Placebo as oral capsule in randomized order
|
Placebo
A selective stimulator of soluble guanylate cyclase (sGC)
Other Names:
|
Other: Placebo / Riociguat
Riociguat or Placebo as oral capsule in randomized order
|
Placebo
A selective stimulator of soluble guanylate cyclase (sGC)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in incidence of migraine attacks between riociguat and placebo during a 12-hour observational period after ingestion.
Time Frame: 0-12 hours
|
Data will be collected with a questionnaire.
|
0-12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in superficial temporal artery (STA) diameter between baseline and 90 minutes after receiving riociguat compared to placebo.
Time Frame: 0-90 minutes
|
Measured by high resolution ultrasonography.
|
0-90 minutes
|
Difference in superficial temporal artery (STA) diameter between baseline and onset of migraine attack after receiving riociguat (maximum 6 hours after receiving riociguat) compared to placebo.
Time Frame: 0-6 hours (max)
|
STA diameter will be measured by high resolution ultrasonography.
Data on migraine attack will be collected with a questionnaire.
|
0-6 hours (max)
|
Difference in middle cerebral artery (MCA) blood flow velocity between baseline and 90 minutes after receiving riociguat compared to placebo.
Time Frame: 0-90 minutes
|
Measured by transcranial doppler.
|
0-90 minutes
|
Difference in middle cerebral artery (MCA) blood flow velocity between baseline and onset of migraine attack after receiving riociguat (maximum 6 hours after receiving riociguat) compared to placebo.
Time Frame: 0-6 hours (max)
|
MCA blood flow velocity will be measured by transcranial doppler.
Data on migraine attack will be collected with a questionnaire.
|
0-6 hours (max)
|
Difference in incidence of headache (>0 on Numeric Rating Scale (NRS) from 0 to 10, where 0="no pain" versus 1-10="pain") between riociguat and placebo during a 12-hour observational period after ingestion.
Time Frame: 0-12 hours
|
Data will be collected with a questionnaire.
|
0-12 hours
|
Difference in severity of headache rated on 11-point NRS from 0 ("no pain") to 10 ("worst pain imaginable") between riociguat and placebo during a 12-hour observational period after ingestion.
Time Frame: 0-12 hours
|
Data will be collected with a questionnaire.
|
0-12 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in use of rescue medication to treat headache and migraine attack between riociguat and placebo during a 12-hour observational period after ingestion.
Time Frame: 0-12 hours
|
Exploratory outcome.
Data will be collected with a questionnaire.
|
0-12 hours
|
Difference in superficial temporal artery (STA) diameter in the time-course from baseline until 6 hours after receiving riociguat compared to placebo.
Time Frame: 0-6 hours
|
Exploratory outcome.
Measured by high resolution ultrasonography.
|
0-6 hours
|
Difference in middle cerebral artery (MCA) blood flow velocity in the time-course from baseline until 6 hours after receiving riociguat compared to placebo.
Time Frame: 0-6 hours
|
Exploratory outcome.
Measured by transcranial doppler.
|
0-6 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Messoud B Ashina, MD, Ph.D., DMSc., Danish Headache Center
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-22041677
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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