Health Condition 1: G439- Migraine, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Have a history of migraine as defined by the International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2006) of at least 1 year prior to enrollment, migraine onset prior to age 50, and a moderate frequency of migraine headaches Have clinical laboratory test results within normal reference ranges or, if outside the normal range, judged not clinically significant by the Investigator Must not be on any migraine prevention therapy, including botulinum toxin (Botox) Agree not to post any personal medical data related to the study or information related to the study on any website or social media site (for example, Facebook, Twitter, et cetera) until the trial has completed.
Exclusion criteria
Exclusion criteria: Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device, or concurrent enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study. History of chronic migraine or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and basilar-type migraine History of headache (for example, cluster headache or Medication Overuse Headache [MOH]) other than migraine or tension type headache as defined by IHS ICHD-II within 12 months prior to randomization Evidence of significant active psychiatric disease including, but not limited to, manic depressive illness, schizophrenia, generalized anxiety disorder, obsessive compulsive disorder, personality disorders, or other serious mood, anxiety, depression, or substance use disorders Women who are pregnant or nursing Excessive alcohol, opiate, or barbiturate use; history of drug abuse or dependence Patients who are terminally ill, under immunosuppressive treatment or self-reported immunocompromised state. Unwilling to take part and not giving consent to join the study or unable to read patient information sheet.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment will be done using MIDAS SCALETimepoint: One at the baseline and other at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Depending upon the severity of the symptoms and as per the need and necessity of the caseTimepoint: Every 2 weeks | — |
Countries
India
Contacts
NHMC University of Delhi