MigrainePhase 3NCT00330850
An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack
A Phase 3 study testing PRO-513 in people with Migraine and Photophobia, run by ProEthic Pharmaceuticals at 16 sites in United States.
Trial summary
The purpose of the study is to show the efficacy of a single dose of PRO-513 for treating subjects suffering moderate pain form a migraine attack, with or without aura. The study is also intended to show the effectiveness of PRO-513 for associated symptoms of nausea, photophobia, and phonophobia due to a migraine… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Photophobia, Phonophobia
- What is being tested?
- PRO-513
- How many people
- 650 participants
- Where
- 16 sitesUnited States
- Study dates
- May 2006to Dec 2006
- 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
- Male and Female subjects
- 18-65 years of age
- Primary diagnosis of migraine attack with aura or migraine attack without aura
- Migraine history of averaging at least 1 migraine attack per month but averaging not more than 6 migraine attacks per month over the prior year
- Female subjects must use an effective form of birth control
- Listing of additional inclusion criteria are available through the Sponsor
Who cannot join
- Excluding subjects with a history of other serious events causing secondary headaches
- Excluding subjects with a current medical condition that could interfere with the overall study intent or affect the absorption, distribution, metabolism, or excretion of the study medication
- Excluding subjects with a history or current medical condition that could confound the study results or use of a concomitant medication that could interfere with the study drug
- Listing of additional exclusion criteria are available through the Sponsor
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
The Innovative Clinical Research Center
Alexandria, Virginia, 22304
Michigan Head-Pain and Neurologic Institute
Ann Arbor, Michigan, 48104
DermResearch, Inc.
Austin, Texas, 78759
J&S Studies, Inc.
Bryan, Texas, 77802
Diamond Headache Clinic
Chicago, Illinois, 60614
Associated Neurologists of Southern CT
Fairfield, Connecticut, 06824
LCFP Inc.
Fort Myers, Florida, 33907
Headache Wellness Center
Greensboro, North Carolina, 27401
Houston Headache Clinic
Houston, Texas, 77004
Advanced Healthcare, S.C.
Milwaukee, Wisconsin, 53209
New York Headache Center
New York, New York, 10021
Palm Beach Neurological Center
Palm Beach Gardens, Florida, 33410
Road Runner Research, Ltd.
San Antonio, Texas, 78258
Mercy Health Research
St Louis, Missouri, 63141
New England Center for Headache
Stamford, Connecticut, 06902
International Research Center
Towson, Maryland, 21286
About this study
The purpose of the study is to show the efficacy of a single dose of PRO-513 for treating subjects suffering moderate pain form a migraine attack, with or without aura. The study is also intended to show the effectiveness of PRO-513 for associated symptoms of nausea, photophobia, and phonophobia due to a migraine attack.
- Conditions
- Migraine, Photophobia, Phonophobia
- Being tested
- PRO-513
- Keywords
- Migraine, Photophobia, Phonophobia, Aura
- Medical subject headings
- Migraine Disorders, Photophobia, Hyperacusis, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-513Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startMay 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- Masking
- Double blind
- Enrolment
- 650 participants
Sponsor and investigators
- Lead sponsor
- ProEthic Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Lipton, MD, Principal investigator, Montefiore Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330850
- Sponsor's protocol ID
- PRO-513301
- Status last verified
- Mar 2007
- First submitted
- 26 May 2006
- Last updated
- 2 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack
- ClinicalTrials.gov ID
- NCT00330850
- Acronym / sponsor ID
- PRO-513301
- Conditions
- Migraine, Photophobia, Phonophobia
- Keywords
- Migraine, Photophobia, Phonophobia, Aura
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants
- Lead sponsor
- ProEthic PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Dec 2006
- First posted
- 29 May 2006 (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 the study is to show the efficacy of a single dose of PRO-513 for treating subjects suffering moderate pain form a migraine attack, with or without aura. The study is also intended to show the effectiveness of PRO-513 for associated symptoms of nausea, photophobia, and phonophobia due to a migraine attack.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and Female subjects
- 18-65 years of age
- Primary diagnosis of migraine attack with aura or migraine attack without aura
- Migraine history of averaging at least 1 migraine attack per month but averaging not more than 6 migraine attacks per month over the prior year
- Female subjects must use an effective form of birth control
Key exclusion criteria (4 listed)
- Excluding subjects with a history of other serious events causing secondary headaches
- Excluding subjects with a current medical condition that could interfere with the overall study intent or affect the absorption, distribution, metabolism, or excretion of the study medication
- Excluding subjects with a history or current medical condition that could confound the study results or use of a concomitant medication that could interfere with the study drug
- Listing of additional exclusion criteria are available through the Sponsor
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 |
|---|---|---|
| PRO-513 | Drug | – |
Primary outcome
Not reported in the source record.
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 2 Apr 2007.
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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.
Richard Lipton, MD principal investigator
Montefiore Headache Center
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRO-513 in people with Migraine and Photophobia, run by ProEthic Pharmaceuticals at 16 sites 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 6 inclusion and 4 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 2 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
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.
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 2 Apr 2007.