HeadacheNCT05582811
Effect of Riocigaut on Cerebral Vasodilation and Headache Induction in Healthy Volunteers
A study testing Dose Riociguat 2,5 or 5mg and Riociguat in people with Headache, 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 cerebral arteries and headache inducing properties in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache
- What is being tested?
- Dose Riociguat 2,5 or 5mg and Riociguat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Oct 2022to 1 Jun 2023
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to provide written informed consent and receive participant privacy and rights information.
- Male or female participants aged 18-45 years.
- Weight between 50-100kg
- Non-smokers
Who cannot join
- Any current or previous known primary or secondary headache disorder(s) apart from tension type headache ≤ 1 day per month.
- Headache <48 hours before study start.
- Daily use of any medication except contraceptives. Specifically use of nitrates or nitric oxide donors or phosphodiesterase inhibitors.
- Intake of any pro necessitate medication later than 4 times plasma half-life for the specific drug before study start, except for contraceptives
- 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
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- Positive pregnancy urin screening on screening day or study days.
- A medical history or clinical signs of
- Hypertension (systolic blood pressure >140mmHg and/or diastolic blood pressure >90mmHg)
- 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.
- Blood work at screening with signs of anemia.
- Blood work at screening with signs of abnormal kidney and liver function.
- A medical history or clinical signs of cardiovascular disease including cerebrovascular disease.
- A medical history or clinical signs of pulmonary disease.
- A medical history or clinical signs of liver, renal, gastrointestinal, endocrine, hematological or neurological disease.
- A medical history or clinical signs of psychiatric illness or substance abuse
- A medical history or clinical signs of drug or alcohol abuse
- A medical history or clinical signs of disease of any origin that the investigative doctor finds relevant for participation in the study
- A family history of severe cardiac disease.
- Any history of hypersensitivity to riociguat.
- Subjects who do not want information about crucial pathological findings during the study
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) - Cerebral Vasodilation and Headache Induction in Healthy Volunteers
This double-blind, randomized, placebo-controlled cross-over clinical trial aims to investigate the effects of riocigaut on cerebral arteries and headache inducing properties in healthy volunteers.
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 cranial arterial dilation alongside headache in healthy volunteers.
Twelve healthy volunteers 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 and register possible headache until 4 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.
Leading up to the main study described above, the investigators will conduct a pilot dose-finding study (experimental arm) of increasing doses of riociguat, 2,5mg and 5mg respectively, on two separate study days in 5 healthy volunteers, to ensure an appropriate dose is applied in the main study.
- Conditions
- Headache
- Being tested
- Dose Riociguat 2,5 or 5mg, Riociguat, Placebo
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose Riociguat 2,5 or 5mgDrug
A selective stimulator of soluble guanylate cyclase (sGC)
RiociguatDrug
A selective stimulator of soluble guanylate cyclase (sGC)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dose Riociguat 2,5 or 5mg | Experimental | Riociguat dose finding pilot experiment, 2,5mg and 5mg Receives: Drug: Dose Riociguat 2,5 or 5mg |
| Riociguat | Active comparator | Riociguat orally Receives: Drug: Riociguat |
| Placebo | Placebo comparator | Placebo orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in superficial temporal artery (STA) diameter from baseline to 90 minutes in healthy volunteers after receiving riociguat compared to placebo.
Measured by high resolution ultrasonography.
Measured: 0 - 90 minutes
Secondary outcomes (3)
Change in middle cerebral artery (MCA) blood flow velocity in healthy volunteers after receiving riociguat compared to placebo.
Measured by transcranial doppler from baseline until 4 hours after intake.
Measured: 0 - 4 hours
Changes in heart rate in healthy volunteers after receiving riociguat compared to placebo.
Measured by heart rate
Measured: 0 - 4 hours
Incidence of headache (>0 on Numeric Rating Scale (NRS) from 0 to 10, 0="no pain" versus 1-10="pain") in healthy volunteers until 12 hours after receiving riociguat compared to placebo.
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 posted17 Oct 2022
- Study start26 Oct 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies 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
- 15 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 Ashina, MD, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582811
- Sponsor's protocol ID
- H-22020347
- Status last verified
- Jan 2024
- First submitted
- 10 Oct 2022
- Last updated
- 5 Jan 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 5 Jan 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) - Cerebral Vasodilation and Headache Induction in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05582811
- Acronym / sponsor ID
- H-22020347
- Conditions
- Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 17 Oct 2022 (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 cerebral arteries and headache inducing properties in healthy volunteers.
Detailed description
The investigators believe that activation of sGC could play a role in migraine pathophysiology and propose that stimulation with riociguat causes cranial arterial dilation alongside headache in healthy volunteers.
Twelve healthy volunteers 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 and register possible headache until 4 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.
Leading up to the main study described above, the investigators will conduct a pilot dose-finding study (experimental arm) of increasing doses of riociguat, 2,5mg and 5mg respectively, on two separate study days in 5 healthy volunteers, to ensure an appropriate dose is applied in the main study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Riociguat 2,5 or 5mg | Experimental | Drug: Dose Riociguat 2,5 or 5mgRiociguat dose finding pilot experiment, 2,5mg and 5mg |
| Riociguat | Active comparator | Drug: RiociguatRiociguat orally |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo orally |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ability to provide written informed consent and receive participant privacy and rights information.
- Male or female participants aged 18-45 years.
- Weight between 50-100kg
- Non-smokers
Key exclusion criteria (22 listed)
- Any current or previous known primary or secondary headache disorder(s) apart from tension type headache ≤ 1 day per month.
- Headache <48 hours before study start.
- Daily use of any medication except contraceptives. Specifically use of nitrates or nitric oxide donors or phosphodiesterase inhibitors.
- Intake of any pro necessitate medication later than 4 times plasma half-life for the specific drug before study start, except for contraceptives
- 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.
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 |
|---|---|---|
| Dose Riociguat 2,5 or 5mgA selective stimulator of soluble guanylate cyclase (sGC) | Drug | Dose Riociguat 2,5 or 5mg |
| RiociguatA selective stimulator of soluble guanylate cyclase (sGC) | Drug | Riociguat |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in superficial temporal artery (STA) diameter from baseline to 90 minutes in healthy volunteers after receiving riociguat compared to placebo.
Time frame: 0 - 90 minutes
Measured by high resolution ultrasonography.
3 secondary outcomes
Change in middle cerebral artery (MCA) blood flow velocity in healthy volunteers after receiving riociguat compared to placebo.
Time frame: 0 - 4 hours
Changes in heart rate in healthy volunteers after receiving riociguat compared to placebo.
Time frame: 0 - 4 hours
Incidence of headache (>0 on Numeric Rating Scale (NRS) from 0 to 10, 0="no pain" versus 1-10="pain") in healthy volunteers until 12 hours after receiving riociguat compared to placebo.
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 5 Jan 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 Ashina, MD 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 Dose Riociguat 2,5 or 5mg and Riociguat in people with 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 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 5 Jan 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. Some participants in this study may receive a placebo. 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?
Change in superficial temporal artery (STA) diameter from baseline to 90 minutes in healthy volunteers after receiving riociguat compared to placebo. (time frame: 0 - 90 minutes). 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 5 Jan 2024.