to evaluate the safety and efficacy of MIGSPRAY (nasal spray) in the prevention of episodic migraines in Migraine patients.
- Conditions
- Health Condition 1: G43C- Periodic headache syndromes in child or adult
- Registration Number
- CTRI/2021/07/034627
- Lead Sponsor
- VITROBIO SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the change from baseline in monthly migraineTimepoint: at day 65
- Secondary Outcome Measures
Name Time Method 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