Effect of Riocigaut on Cerebral Vasodilation and Headache Induction in Healthy Volunteers

NCT05582811 | Completed

• 1 other identifier: H-22020347
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Headache

Outcome Measures

Primary Outcomes (1)

• 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.

  0 - 90 minutes

Secondary Outcomes (3)

• Change in middle cerebral artery (MCA) blood flow velocity in healthy volunteers after receiving riociguat compared to placebo.

  0 - 4 hours

• Changes in heart rate in healthy volunteers after receiving riociguat compared to placebo.

  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.

  0 - 12 hours

Other Outcomes (4)

• Severity of headache, if headache occurs, in healthy volunteers after receiving riociguat compared to placebo, rated on 11-point NRS from 0 ("no pain") to 10 ("worst pain imaginable") from baseline to 12 hours after intake.

  0 - 12 hours

• Headache characteristics, if headache occurs, in healthy volunteers after receiving riociguat compared to placebo, rated from baseline to 12 hours after intake.

  0 - 12 hours

• Reported use of rescue medication if headache occurs, in healthy volunteers, after receiving riociguat compared to placebo.

  0 - 12 hours

Study Arms (3)

Dose Riociguat 2,5 or 5mg

EXPERIMENTAL

Riociguat dose finding pilot experiment, 2,5mg and 5mg

Drug: Dose Riociguat 2,5 or 5mg

Riociguat

ACTIVE COMPARATOR

Riociguat orally

Drug: Riociguat

Placebo

PLACEBO COMPARATOR

Placebo orally

Drug: Placebo

Interventions

Dose Riociguat 2,5 or 5mg DRUG

A selective stimulator of soluble guanylate cyclase (sGC)

Dose Riociguat 2,5 or 5mg

Riociguat DRUG

A selective stimulator of soluble guanylate cyclase (sGC)

Riociguat

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Copenhagen, Glostrup, 2600, Denmark

Location

MeSH Terms

Conditions

Headache

Interventions

riociguat

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Messoud Ashina, MD

  Danish Headache Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D., DMSc., Chief Consultant Neurologist

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 17, 2022
• Study Start: October 26, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)