Migraine With Aura, Migraine Without Aura
Conditions
Brief summary
The purpose of this study is to show the efficacy of promethazine in management of patients with moderate to severe migraine
Interventions
DRUGSumatriptan+Promethazine (SPr)
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients who aged 18 to 65 years with a clinical history of migraine with or without aura (International Headache Society categories 1.1 or 1.2) for at least 1 year * Subjects who have mean frequency of 2-8 migraine attacks per month.
Exclusion criteria
* Complex form of migraine, medication overuse headache, history of chronic tension-type headache, ophthalmoplegic, basilar and hemiplegic migraine * Uncontrolled hypertension (diastolic blood pressure \>95 mm Hg or systolic blood pressure \>160 mm Hg) * History or clinical evidence of cerebrovascular or cardiovascular disorder * Renal impairment or dialysis dependence * Serious illness (physical or psychiatric disorders) * Drugs and alcohol abuse * Pregnancy and breastfeeding * Allergy or hypersensitivity to promethazine or triptans * Concurrent use of ergotamine-containing drugs, monoamine oxidize inhibitors, antidepressant, lithium
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete headache relief | At 2 hours after first dose | The primary endpoint variable was the proportions of patients reporting complete headache relief 2 hours after dosing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache improvement. | At 0.5 hour, 1 hour, 2 hours, 4 hours after first dose. | The secondary endpoint variable was the proportion of patients experiencing headache improvement at 0.5 hour, 1 hour, 2 hours, 4 hours after dosing. |
| Using the second dose of study medications. | At 2-48 hours after first dose. | The secondary endpoint variable was the use of second dose when the severity of headache was still moderate or severe after the first dose within 2-48 hours |
| Complete headache relief | At 0.5 hour, 1 hour, and 4 hours after first dose | The secondary endpoint variable was the proportions of patients reporting complete headache relief 0.5 hour, 1 hour, and 4 hours after dosing. |
| Rate of headache recurrence | At 2-48 hours after first dose. | The secondary endpoint variable was a return to moderate or severe pain within 48 hours of first dose subsequent to primary improvement to mild or no pain at 2 hours. |
| Occurrence of adverse events. | At 4 hours after first dose. | Presence or absence of adverse events occurred 4 hours after first dosing. |
| Using rescue medication between 2 and 48 hours postdose | At 4-48 hours after second dose. | The secondary endpoint variable was the use of rescue medication (excluding triptans, and ergot-containing medication) within 4-48 hours after the second dose when headache severity was still at grade 2 ⁄ 3. |
Countries
Iran
Outcome results
None listed