Migraine Without AuraNCT05750446
Effect of Riocigaut on Migraine Attack Induction in People With Migraine
A study testing Riociguat (BAY 63-2521) in people with Migraine Without Aura, run by Danish Headache Center at 1 site in Denmark.
Trial summary
This double-blind, randomized, placebo-controlled cross-over clinical trial aims to investigate the effects of riocigaut on migraine inducing properties in people with migraine. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Migraine Without Aura
- What is being tested?
- Riociguat (BAY 63-2521)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2023to 1 Feb 2024
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- An estimated average of between 1-5 migraine attacks per month.
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Riociguat (BAY 63-2521), a Stimulator of Soluble Guanylate Cyclase (sGC) - Migraine Induction in People With Migraine.
This double-blind, randomized, placebo-controlled cross-over clinical trial aims to investigate the effects of riocigaut on migraine inducing properties in people with migraine.
Read the 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 in people with migraine.
Twenty-one people with migraine are expected to be included. They 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 heart rate, blood pressure and register possible headache/migraine including associated symptoms until 2 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.
- Conditions
- Migraine Without Aura
- Being tested
- Riociguat (BAY 63-2521), Placebo
- Keywords
- Riociguat, Migraine, Migraine Without Aura, Headache, Pain, Enzyme Activators, Neurologic Manifestations, Molecular Mechanisms of Pharmacological Action
- Medical subject headings
- Migraine without Aura, Migraine Disorders, Headache, Pain, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riociguat (BAY 63-2521)Drug
Also called Adempas
A selective stimulator of soluble guanylate cyclase (sGC)
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Riociguat / Placebo | Other | Riociguat or Placebo as oral capsule in randomized order Receives: Drug: Riociguat (BAY 63-2521); Other: Placebo |
| Placebo / Riociguat | Other | Riociguat or Placebo as oral capsule in randomized order Receives: Drug: Riociguat (BAY 63-2521); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in incidence of migraine attacks between riociguat and placebo during a 12-hour observational period after ingestion.
Data will be collected with a questionnaire.
Measured: 0-12 hours
Secondary outcomes (1)
Difference in Area Under the Curve (AUC) values for median headache intensity scores (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.
Data will be collected with a questionnaire.
Measured: 0-12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Jun 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Messoud Ashina, MD, Danish Headache Center
- Investigators
- Messoud B Ashina, MD, Phd, DMSc, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750446
- Sponsor's protocol ID
- H-22041677
- Status last verified
- Jul 2024
- First submitted
- 20 Feb 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Riociguat (BAY 63-2521), a Stimulator of Soluble Guanylate Cyclase (sGC) - Migraine Induction in People With Migraine.
- ClinicalTrials.gov ID
- NCT05750446
- Acronym / sponsor ID
- H-22041677
- Conditions
- Migraine Without Aura
- Keywords
- Riociguat, Migraine, Migraine Without Aura, Headache, Pain, Enzyme Activators, Neurologic Manifestations, Molecular Mechanisms of Pharmacological Action
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 1 Mar 2023 (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.
This double-blind, randomized, placebo-controlled cross-over clinical trial aims to investigate the effects of riocigaut on migraine inducing properties in people with migraine.
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 in people with migraine.
Twenty-one people with migraine are expected to be included. They 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 heart rate, blood pressure and register possible headache/migraine including associated symptoms until 2 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Riociguat / Placebo | Other | Drug: Riociguat (BAY 63-2521), Other: PlaceboRiociguat or Placebo as oral capsule in randomized order |
| Placebo / Riociguat | Other | Drug: Riociguat (BAY 63-2521), Other: PlaceboRiociguat or Placebo as oral capsule in randomized order |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
- An estimated average of between 1-5 migraine attacks per month.
- 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.
Key exclusion criteria (22 listed)
- 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).
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 |
|---|---|---|
| Riociguat (BAY 63-2521)Also: AdempasA selective stimulator of soluble guanylate cyclase (sGC) | Drug | Placebo / Riociguat, Riociguat / Placebo |
| PlaceboPlacebo | Other | Placebo / Riociguat, Riociguat / Placebo |
Primary outcome
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.
1 secondary outcome
Difference in Area Under the Curve (AUC) values for median headache intensity scores (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
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 12 Jul 2024.
- Individual participant dataSharing planned: No
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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 B Ashina, MD, Phd, DMSc principal investigator
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 Riociguat (BAY 63-2521) 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 6 inclusion and 22 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 12 Jul 2024. 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?
Difference in incidence of migraine attacks between riociguat and placebo during a 12-hour observational period after ingestion. (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 12 Jul 2024.