Effect of Riocigaut on Migraine Attack Induction in People With Migraine

NCT05750446 | Completed

• 1 other identifier: H-22041677
• Study Type: interventional
• Target: 22
• 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 migraine inducing properties in people with migraine.

Conditions

Migraine Without Aura

Keywords

Riociguat; Migraine; Migraine Without Aura; Headache; Pain; Enzyme Activators; Neurologic Manifestations; Molecular Mechanisms of Pharmacological Action

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  0-12 hours

Study Arms (2)

Riociguat / Placebo

OTHER

Riociguat or Placebo as oral capsule in randomized order

Drug: Riociguat (BAY 63-2521); Other: Placebo

Placebo / Riociguat

OTHER

Riociguat or Placebo as oral capsule in randomized order

Drug: Riociguat (BAY 63-2521); Other: Placebo

Interventions

Riociguat (BAY 63-2521) DRUG

A selective stimulator of soluble guanylate cyclase (sGC)

Also known as: Adempas

Placebo / Riociguat; Riociguat / Placebo

Placebo OTHER

Placebo

Placebo / Riociguat; Riociguat / Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Copenhagen, Glostrup, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine without Aura; Migraine Disorders; Headache; Pain; Neurologic Manifestations

Interventions

riociguat

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Messoud B Ashina, MD, Phd, DMSc

  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: February 20, 2023
• First Posted: March 1, 2023
• Study Start: June 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)