Health Condition 1: G438- Other migraine
Conditions
Interventions
None listed
Sponsors
Amrutanjan Health Care Limited, Tamil Nadu, India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants of either gender, aged 18 65 years. 2. Participants who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily. 3. Participants who are diagnosed with migraine-type headache (Common Migraine, Classical Migraine, Ophthalmic Migraine and Basilar Migraine) as per The International Classification of Headache Disorders 3rd edition (ICHD-3) criteria. 4. Participants with pain score greater than or equal to 3/10 (based on numeric pain rating scale) during the past 1 week. 5. Migraine attacks present for more than 1 year. 6. Migraine attacks, on average, lasting about 4 - 72 hours if untreated. 7. 1 to 8 migraine days per month on average across the 3 months prior to the Screening Visit 8. Less than 15 headache days (migraine or non-migraine) per month in each of the 3 months prior to the screening visit and throughout the screening phase.
Exclusion criteria
Exclusion criteria: 1. Women of child bearing potential who are either unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (implants or injectable products, vaginal products, skin patches), or IUDs, barrier methods] to avoid pregnancy during the study period. 2. Pregnant or lactating participants 3. Inability to distinguish other headaches from migraine 4. History of resistance to sumatriptan, or non-response to 2 or more other triptans, defined as participants who have not responded to an adequate dose and duration of treatment 5. Current use of medication for migraine prophylaxis that has not been stable (no dose adjustment) for 30 days prior to screening 6. Chronic opioid therapy (greater than 3 consecutive days in the 30 days prior to screening) 7. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome 8. Known allergy to compounds of test product. 9. Participants suffering from medical or psychiatric conditions that would increase the risk of adverse events or interfere with study assessments. 10. Participation in an investigational drug trial during the last 30 days. 11. Immuno-compromised (history) individuals like known HIV positive participants or participants who are on treatment with steroids or immunomodulators. 12. Participants of vulnerable group (e.g. seriously ill, mentally challenged). 13. History of drug or alcohol abuse during the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to onset of relief of pain [Time frame: 0-120 minutes post dose] 2. Time to achieve complete relief of pain [Time frame: 0-120 minutes post dose] 3. Reduction in pain score on numeric pain rating scale (VAS) [Time frame: 30 seconds, 1 minute, 2minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes post dose] 4. Assessment of pain relief by using McGill Pain questionnaire. [Time frame: 0-120 minutes post dose and end of 24 hours] 5. Participants overall satisfaction for pain relief on a 7- point Likert Satisfaction scale [Time Frame: on day 2 - post dose] Timepoint: 30 seconds, 1 minute, 2minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AE) and serious adverse events (SAE) will be monitoredTimepoint: 0-24 hours | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Ki3 Private Limited
Outcome results
None listed