Migraine DisordersPhase 3NCT02779959
Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT
A Phase 3 study testing Prochlorperazine in people with Migraine Disorders, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial summary
Headache is a common presenting complaint to the emergency department accounting for 1-2% of patient visits. Of these headaches, approximately 90% are migraine, tension headache, or combined presentations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Prochlorperazine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Apr 2018
- 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 between 18-65 years of age evaluated in the emergency department at Harbor-UCLA with migraine headache as defined by the Headache Classification Committee of the International Headache Society. (Patients must have had at least one prior similar headache, with or without nausea, vomiting, aura, photophobia, or phonophobia).
- Only subjects able to consent to treatment will be included.
Who cannot join
- Patients with the following conditions:
- pregnancy
- breastfeeding
- fever greater or equal to 100.4 degrees
- diastolic blood pressure of 105 or higher
- altered mental status
Show all 10Show fewer
- meningeal signs
- suspicion for intracranial process requiring further investigation
- known allergy to prochlorperazine
- the use of ergotamines, antiemetics, antipsychotics or sedatives in the previous 24 hours of study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Headache is a common presenting complaint to the emergency department accounting for 1-2% of patient visits. Of these headaches, approximately 90% are migraine, tension headache, or combined presentations. The most commonly used migraine therapy in the ED is intravenous prochlorperazine, but its administration requires close nursing observation, a bed, and the insertion of an intravenous catheter. Buccal prochlorperazine represents an alternative form of delivery that enables rapid achievement of therapeutic blood levels and may lead to symptom resolution. In a randomized, controlled, prospective study,the investigators plan to assess the efficacy of buccal versus intravenous prochlorperazine for the initial emergency department treatment of migraine headaches.
- Conditions
- Migraine Disorders
- Being tested
- Prochlorperazine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProchlorperazineDrug
| Study group | Role | What they receive |
|---|---|---|
| Buccal Prochlorperazine | Experimental | Experimental arm of two buccally absorbable prochlorperazine tablets (6 mg) plus 2 cc IV saline Receives: Drug: Prochlorperazine |
| Intravenous Prochlorperazine | Active comparator | Accepted Standard of care receiving 10 mg (2 cc) of intravenous prochlorperazine plus two saccharin absorbable placebo tablets. Receives: Drug: Prochlorperazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in median pian VAS score
Primary end point will be a detectable difference in the median pain VAS score recorded from Time 0 (baseline) to Time 60 minutes (conclusion of the study) for each of the two groups.
Measured: From Time 0 (baseline) to Time 60 minutes after administration of medication
Secondary outcomes (4)
Change in median sedation VAS scores
Secondary endpoints will include a detectable difference in median sedation VAS scale from Time 0 (baseline) to Time 60 minutes (conclusion of the study for each of the two groups.
Measured: From Time 0 (baseline) to Time 60 minutes after administration of medication
Change in median nausea VAS scores
Secondary endpoints will include a detectable difference in median nausea VAS scale from Time 0 (baseline) to Time 60 minutes (conclusion of the study for each of the two groups.
Measured: From Time 0 (baseline) to Time 60 minutes after administration of medication
Rescue Medication
Comparison between groups for the need for rescue medication as determined by the primary care provider.
Measured: At the conclusion of the study (60 minutes)
Follow-up for persistence or recurrence of headache
Using a Pain Relief Scale, subjects will be contacted by telephone at 24 - 48 hours after the conclusion of the study and asked to rate their current headache pain.
Measured: 24 -48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2017
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Tanen, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- David Tanen, MD, Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779959
- Sponsor's protocol ID
- 30590-01
- Status last verified
- Jan 2018
- First submitted
- 17 May 2016
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT
- ClinicalTrials.gov ID
- NCT02779959
- Acronym / sponsor ID
- 30590-01
- Conditions
- Migraine Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Apr 2018 (estimated)
- First posted
- 23 May 2016 (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.
Headache is a common presenting complaint to the emergency department accounting for 1-2% of patient visits. Of these headaches, approximately 90% are migraine, tension headache, or combined presentations. The most commonly used migraine therapy in the ED is intravenous prochlorperazine, but its administration requires close nursing observation, a bed, and the insertion of an intravenous catheter. Buccal prochlorperazine represents an alternative form of delivery that enables rapid achievement of therapeutic blood levels and may lead to symptom resolution. In a randomized, controlled, prospective study,the investigators plan to assess the efficacy of buccal versus intravenous prochlorperazine for the initial emergency department treatment of migraine headaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buccal Prochlorperazine | Experimental | Drug: ProchlorperazineExperimental arm of two buccally absorbable prochlorperazine tablets (6 mg) plus 2 cc IV saline |
| Intravenous Prochlorperazine | Active comparator | Drug: ProchlorperazineAccepted Standard of care receiving 10 mg (2 cc) of intravenous prochlorperazine plus two saccharin absorbable placebo tablets. |
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 between 18-65 years of age evaluated in the emergency department at Harbor-UCLA with migraine headache as defined by the Headache Classification Committee of the International Headache Society. (Patients must have had at least one prior similar headache, with or without nausea, vomiting, aura, photophobia, or phonophobia).
- Only subjects able to consent to treatment will be included.
Key exclusion criteria (10 listed)
- pregnancy
- breastfeeding
- fever greater or equal to 100.4 degrees
- diastolic blood pressure of 105 or higher
- altered mental status
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 |
|---|---|---|
| Prochlorperazine | Drug | Buccal Prochlorperazine, Intravenous Prochlorperazine |
Primary outcome
Change in median pian VAS score
Time frame: From Time 0 (baseline) to Time 60 minutes after administration of medication
Primary end point will be a detectable difference in the median pain VAS score recorded from Time 0 (baseline) to Time 60 minutes (conclusion of the study) for each of the two groups.
4 secondary outcomes
Change in median sedation VAS scores
Time frame: From Time 0 (baseline) to Time 60 minutes after administration of medication
Change in median nausea VAS scores
Time frame: From Time 0 (baseline) to Time 60 minutes after administration of medication
Rescue Medication
Time frame: At the conclusion of the study (60 minutes)
Follow-up for persistence or recurrence of headache
Time frame: 24 -48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Individual participant dataSharing planned: No
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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.
David Tanen, MD principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA 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 3 study testing Prochlorperazine in people with Migraine Disorders, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 5 Jan 2018. 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 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?
Results are not available in the source record.
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?
Change in median pian VAS score (time frame: From Time 0 (baseline) to Time 60 minutes after administration of medication). 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 5 Jan 2018.