Migraine With AuraPhase 3NCT01814189
Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment
A Phase 3 study testing Sumatriptan+Promethazine (SPr) in people with Migraine With Aura and Migraine Without Aura, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to show the efficacy of promethazine in management of patients with moderate to severe migraine Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine With Aura, Migraine Without Aura
- What is being tested?
- Sumatriptan+Promethazine (SPr)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteIran
- Study dates
- Jan 2013to Apr 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy and breastfeeding
- Allergy or hypersensitivity to promethazine or triptans
- Concurrent use of ergotamine-containing drugs, monoamine oxidize inhibitors, antidepressant, lithium
Trial locations and contacts
1 site in 1 country.
Iran1 site
Department of Neurology, Emam Hossein Hospital
Tehran, Tehran Province, 17666-33812
About this study
Official title: Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment: a Randomized, Double Blind Clinical Trial
The purpose of this study is to show the efficacy of promethazine in management of patients with moderate to severe migraine
- Conditions
- Migraine With Aura, Migraine Without Aura
- Being tested
- Sumatriptan+Promethazine (SPr)
- Medical subject headings
- Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sumatriptan+Promethazine (SPr)Drug
| Study group | Role | What they receive |
|---|---|---|
| sumatriptan+promethazine (SPr) | Active comparator | The SPr group denote patients receiving oral sumatriptan (50 mg) plus oral promethazine (50 mg). Receives: Drug: Sumatriptan+Promethazine (SPr) |
| Sumatriptan+placebo (SP) | Placebo comparator | The SP group denote patients receiving oral sumatriptan (50 mg) plus tablet of placebo matched to promethazine. Receives: Drug: Sumatriptan+Promethazine (SPr) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete headache relief
The primary endpoint variable was the proportions of patients reporting complete headache relief 2 hours after dosing.
Measured: At 2 hours after first dose
Secondary outcomes (6)
Complete headache relief
The secondary endpoint variable was the proportions of patients reporting complete headache relief 0.5 hour, 1 hour, and 4 hours after dosing.
Measured: At 0.5 hour, 1 hour, and 4 hours after first dose
Headache improvement.
The secondary endpoint variable was the proportion of patients experiencing headache improvement at 0.5 hour, 1 hour, 2 hours, 4 hours after dosing.
Measured: At 0.5 hour, 1 hour, 2 hours, 4 hours after first dose.
Using the second dose of study medications.
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
Measured: At 2-48 hours after first dose.
Using rescue medication between 2 and 48 hours postdose
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.
Measured: At 4-48 hours after second dose.
Rate of headache recurrence
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.
Measured: At 2-48 hours after first dose.
Occurrence of adverse events.
Presence or absence of adverse events occurred 4 hours after first dosing.
Measured: At 4 hours after first dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine With AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shadi Asadollahi, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814189
- Sponsor's protocol ID
- SB-045
- Status last verified
- Jul 2013
- First submitted
- 14 Mar 2013
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment: a Randomized, Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT01814189
- Acronym / sponsor ID
- SB-045
- Conditions
- Migraine With Aura, Migraine Without Aura
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 19 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to show the efficacy of promethazine in management of patients with moderate to severe migraine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sumatriptan+promethazine (SPr) | Active comparator | Drug: Sumatriptan+Promethazine (SPr)The SPr group denote patients receiving oral sumatriptan (50 mg) plus oral promethazine (50 mg). |
| Sumatriptan+placebo (SP) | Placebo comparator | Drug: Sumatriptan+Promethazine (SPr)The SP group denote patients receiving oral sumatriptan (50 mg) plus tablet of placebo matched to promethazine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sumatriptan+Promethazine (SPr) | Drug | Sumatriptan+placebo (SP), sumatriptan+promethazine (SPr) |
Primary outcome
Complete headache relief
Time frame: At 2 hours after first dose
The primary endpoint variable was the proportions of patients reporting complete headache relief 2 hours after dosing.
6 secondary outcomes
Complete headache relief
Time frame: At 0.5 hour, 1 hour, and 4 hours after first dose
Headache improvement.
Time frame: At 0.5 hour, 1 hour, 2 hours, 4 hours after first dose.
Using the second dose of study medications.
Time frame: At 2-48 hours after first dose.
Using rescue medication between 2 and 48 hours postdose
Time frame: At 4-48 hours after second dose.
Rate of headache recurrence
Time frame: At 2-48 hours after first dose.
Occurrence of adverse events.
Time frame: At 4 hours after first dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sumatriptan+Promethazine (SPr) in people with Migraine With Aura and Migraine Without Aura, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete headache relief (time frame: At 2 hours after first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2013.