Migraine HeadachesPhase 4MigraineNCT01629329
Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine
A Phase 4 study testing Aspirin, Acetaminophen, Caffeine pills and Prochlorperazine 10mg in people with Migraine Headaches, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
The objective of this randomized, double blind study is to demonstrate that one dose oral "excedrin migraine" (acetaminophen, aspirin and caffeine) is not inferior when compared to one dose of intravenous prochlorperazine for the treatment of acute migraine headaches in the emergency department. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Headaches
- What is being tested?
- Aspirin, Acetaminophen, Caffeine pills and Prochlorperazine 10mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jul 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 years or older
- Headache must meet the IHS criteria for migraine or probable migraine
- 2 out of 4 of following:
- Unilateral location
- Throbbing (pulsating) quality
- Moderate to severe intensity (inhibits/prohibits daily activities)
Show all 11Show fewer
- Exacerbation with moderate activity or mild activity
- During HA, at least 1 out of 3 of following:
- Nausea and/or vomiting
- Photophobia
- Phonophobia
Who cannot join
- Known allergy to study medications
- Pregnancy
- < 18 years old
- Inability to provide written, informed consent
- Patients with positive lumbar puncture or positive CT scan for suspected secondary headache
- History of peptic ulcer disease
Show all 12Show fewer
- History of liver failure
- History of coagulopathy
- Gastrointestinal bleeding within the last 3 months
- Previous gastrointestinal bleeding with non-steroidal anti-inflammatory medications
- Ingestion of other pain medications within the previous six hours deemed to put the patient at risk of exceeding a toxic dose of ASA or acetaminophen (> 100mg/kg for ASA or acetaminophen)
- Vomiting within one hour of receiving oral study medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
About this study
Official title: A Randomized, Double-blind Comparison of Single Dose Prochlorperazine Versus Acetaminophen, Aspirin and Caffeine for the Treatment of Acute Migraine in the Emergency Department.
The objective of this randomized, double blind study is to demonstrate that one dose oral "excedrin migraine" (acetaminophen, aspirin and caffeine) is not inferior when compared to one dose of intravenous prochlorperazine for the treatment of acute migraine headaches in the emergency department.
Read the detailed description
Patients with severe headaches often come to the emergency department seeking relief from their symptoms. There is some dating suggesting that over the counter treatment options are not inferior to treatment options offered in emergency departments. Patients presenting to the Einstein Emergency Department with IHS criteria for migraine headache will be approached by research associate and offered to participate in a randomized double blind study comparing excedrin migraine to compazine. Patients will be randomized by the hospital pharmacy. The pharmacy will distribute one of two packets, one containing prochlorperazine 10mg and 2 placebo tablets, the other containing 2 generic AAC tablets without scoring (acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet) and a placebo syringe. Patients will be monitored for improvement of pain, change in vital signs, and adverse events for two hours after receiving drugs. At 24 hours, the patients will be called back to access if they experienced any side effects from the time of discharge, and if they would take this medicine again if they experienced another migraine.
- Conditions
- Migraine Headaches
- Being tested
- Aspirin, Acetaminophen, Caffeine pills, Prochlorperazine 10mg
- Keywords
- Headache, prochlorperazine, excedrin migraine, treatment efficacy, pain scores
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin, Acetaminophen, Caffeine pillsDrug
Also called Excedrin
One time dose of 2 pills each containing acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet. Simultaneous administration of placebo(5ml of saline administered IV)
Prochlorperazine 10mgDrug
Also called Compazine
One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin, Acetaminophen, Caffeine pills | Active comparator | Patients receiving AAC(acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet)will receive 2 pills with active compound and placebo syringe with 2 ml of saline. Receives: Drug: Aspirin, Acetaminophen, Caffeine pills |
| Prochlorperazine 10mg | Active comparator | Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills Receives: Drug: Prochlorperazine 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Difference From Baseline of VAS Pain Scores
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Measured: 60 minutes from drug administration
Secondary outcomes (1)
Number of Reported Adverse Side-effects
Secondary endpoints will also be assessed at 30min, 90min and 120min. Additional secondary endpoints will be in the number of reported adverse side-effects, defined as muscle spasm, tiredness, extreme restlessness, GI upset, vomiting in the ED and treatment failure rate.
Measured: 30, 90, and 120 minutes from drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startNov 2010
- Primary completionApr 2014
- Study completionJul 2014
Why it stopped: no difference found between two groups in a preliminary analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Migraine HeadachesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Deitch, DO, Principal investigator, Albert Einstein Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629329
- Sponsor's protocol ID
- 4258
- Acronym
- Migraine
- Status last verified
- Jun 2014
- First submitted
- 25 Jun 2012
- Last updated
- 18 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Comparison of Single Dose Prochlorperazine Versus Acetaminophen, Aspirin and Caffeine for the Treatment of Acute Migraine in the Emergency Department.
- ClinicalTrials.gov ID
- NCT01629329
- Acronym / sponsor ID
- Migraine / 4258
- Conditions
- Migraine Headaches
- Keywords
- Headache, prochlorperazine, excedrin migraine, treatment efficacy, pain scores
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no difference found between two groups in a preliminary analysis
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Jun 2012 (estimated)
- Results
- Posted 18 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this randomized, double blind study is to demonstrate that one dose oral "excedrin migraine" (acetaminophen, aspirin and caffeine) is not inferior when compared to one dose of intravenous prochlorperazine for the treatment of acute migraine headaches in the emergency department.
Detailed description
Patients with severe headaches often come to the emergency department seeking relief from their symptoms. There is some dating suggesting that over the counter treatment options are not inferior to treatment options offered in emergency departments. Patients presenting to the Einstein Emergency Department with IHS criteria for migraine headache will be approached by research associate and offered to participate in a randomized double blind study comparing excedrin migraine to compazine. Patients will be randomized by the hospital pharmacy. The pharmacy will distribute one of two packets, one containing prochlorperazine 10mg and 2 placebo tablets, the other containing 2 generic AAC tablets without scoring (acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet) and a placebo syringe. Patients will be monitored for improvement of pain, change in vital signs, and adverse events for two hours after receiving drugs. At 24 hours, the patients will be called back to access if they experienced any side effects from the time of discharge, and if they would take this medicine again if they experienced another migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin, Acetaminophen, Caffeine pills | Active comparator | Drug: Aspirin, Acetaminophen, Caffeine pillsPatients receiving AAC(acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet)will receive 2 pills with active compound and placebo syringe with 2 ml of saline. |
| Prochlorperazine 10mg | Active comparator | Drug: Prochlorperazine 10mgPatients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years or older
- Headache must meet the IHS criteria for migraine or probable migraine
Key exclusion criteria (12 listed)
- Known allergy to study medications
- Pregnancy
- < 18 years old
- Inability to provide written, informed consent
- Patients with positive lumbar puncture or positive CT scan for suspected secondary headache
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 |
|---|---|---|
| Aspirin, Acetaminophen, Caffeine pillsAlso: ExcedrinOne time dose of 2 pills each containing acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet. Simultaneous administration of placebo(5ml of saline administered IV) | Drug | Aspirin, Acetaminophen, Caffeine pills |
| Prochlorperazine 10mgAlso: CompazineOne time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills. | Drug | Prochlorperazine 10mg |
Primary outcome
Mean Difference From Baseline of VAS Pain Scores
Time frame: 60 minutes from drug administration
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
1 secondary outcome
Number of Reported Adverse Side-effects
Time frame: 30, 90, and 120 minutes from drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Migraine Headaches
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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.
Kenneth Deitch, DO principal investigator
Albert Einstein Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin, Acetaminophen, Caffeine pills and Prochlorperazine 10mg in people with Migraine Headaches, run by Albert Einstein Healthcare Network at 1 site in United States.
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 11 inclusion and 12 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: stopped early, as of the sponsor's last update on 18 Mar 2020. 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 United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Difference From Baseline of VAS Pain Scores (time frame: 60 minutes from drug administration). 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 18 Mar 2020.