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to evaluate the safety and efficacy of MIGSPRAY (nasal spray) in the prevention of episodic migraines in Migraine patients.

A Randomized, Double blind, Clinical Trial to evaluate the safety and efficacy of MIGSPRAY (nasal spray) in the prevention of episodic migraines in Migraine patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/034627
Enrollment
120
Registered
2021-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G43C- Periodic headache syndromes in child or adult

Interventions

Intervention1: MIGSPRAY nasal spray: Duration 56 days Route - Nasal Spray Control Intervention1: Placebo nasal spray: Duration 56 days Route - Nasal Spray

Sponsors

VITROBIO SAS
Lead Sponsor
Mudra Clincare
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients having greater than 1-year history of episodic, migraine (with or without aura) with onset prior to 50 years of age, according to diagnostic criteria established by the International Headache Society. 2 Migraine history during the prior 6 months must include: a at least 4 migraines per month b no more than 15 migraines per month c Women of child-bearing potential must not be pregnant, must agree to avoid pregnancy and use an acceptable double-barrier method of birth control during the trial. 3 Willing and able to treat a minimum of 4 migraines per month with study medication and consistently complete Diary for up to 12 weeks. 4 Patient who has not been using a prophylaxis treatment for at least two months prior to the start of the study.

Exclusion criteria

Exclusion criteria: Patients, >50 years old at migraine onset Pregnant or nursing patients Abuse of crisis treatment Patients having history of cluster or hemiplegic headache Patients having evidence of seizure or major psychiatric disorder Patients having active chronic pain syndrome Patients having Cardiac or hepatic disease Abusing drugs or alcohol Patients having history of a significant mental disorder Patients having hypersensitivity/ history of allergy to any of the Investigational productâ??s components.

Design outcomes

Primary

MeasureTime frame
To evaluate the change from baseline in monthly migraineTimepoint: at day 65—

Secondary

MeasureTime frame
Achievement of at least a 50% reduction from baseline in monthly migraineTimepoint: at day 65;Change from Baseline in acute migraine-specific medication treatmentTimepoint: at day 65;Change from Baseline in headache impact scores as measured by the HIT-6Timepoint: at day 65—

Countries

India

Contacts

Public ContactDr S Sadgune

Mudra Clincare

mudraclincare@gmail.com8291745386

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026