MigrainePhase 2NCT01430442

Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine

A Phase 2 study testing Rimegepant and Sumatriptan in people with Migraine and Acute Treatment of Migraine, run by Pfizer at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary purpose of this study is to evaluate the efficacy of rimegepant (BMS-927711) compared with placebo in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level reported as "no pain") at 2 hours post dose using a four point numeric rating scale (no pain, mild pain, moderate… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Migraine, Acute Treatment of Migraine
What is being tested?: Rimegepant and Sumatriptan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,026 participants
Where: 41 sitesUnited States
Study dates: Oct 2011to May 2012
Phase: Phase 2
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

Patient with at least 1-year history of migraines (with or without aura) including the following:
Migraine attacks more than 1 year with age of onset prior to 50 years of age
Migraine attacks, on average, last about 4 - 72 hours if untreated
No more than 8 attacks of moderate to severe intensity per month within last 3 months
Patient must be able to distinguish migraine attacks from tension/cluster attacks and must have consistent migraine headaches of at least 2 migraine headaches attacks of moderate to severe intensity in each of the last 3 months
Less than 15 days of headache (migraine or non-migraine) per month in each of 3 months prior to screening
Male and female ≥ 18 years and ≤ age 65
No clinically significant abnormality identified on the medical or laboratory evaluation

Who cannot join

Patient has a history of basilar migraine or hemiplegic migraine
Patient does not receive migraine relief from triptan migraine treatment
Medications that may alter the pH of the stomach (acid reducing agents), such as H-2 antagonists, Proton Pump inhibitors (PPI), antacids
History of ergotamine or triptan intake greater than/equal 10 days per month on a regular basis for greater than 3 months
History of non-narcotic analgesic intake on greater then/equal 15 days per month for greater than/equal 3 months

Trial locations and contacts

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

United States41 sites

The Innovative Clinical Research Center
Alexandria, Virginia, 22304
Michigan Head Pain And Neurological Institute
Ann Arbor, Michigan, 48104
Premier Research Group Limited
Austin, Texas, 78705
Futuresearch Trials Of Neurology
Austin, Texas, 78731
Clinsearch, Llc
Chattanooga, Tennessee, 37421
Diamond Headache Clinic, Ltd.
Chicago, Illinois, 60642
Community Research
Cincinnati, Ohio, 45227
Cleveland Clinic
Cleveland, Ohio, 44195
Radiant Research, Inc.
Denver, Colorado, 80239
Regional Clinical Research Inc.
Endwell, New York, 13760
Pharmquest
Greensboro, North Carolina, 27408
The Center For Pharmaceutical Research. Pc
Kansas City, Missouri, 64114
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
Central New York Clinical Research
Manlius, New York, 13104
Miami Research Associates
Miami, Florida, 33143
Milford Emergency Associates, Inc.
Milford, Massachusetts, 01757
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, 29464
Renstar Medical Research
Ocala, Florida, 34471
Compass Research, Llc
Orlando, Florida, 32806
Broward Research Group
Pembroke Pines, Florida, 33026
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Clinical Research Of Philadelphia, Llc
Philadelphia, Pennsylvania, 19114
Wake Research Associates
Raleigh, North Carolina, 27612
Rochester Clinical Research, Inc.
Rochester, New York, 14609
J. Lewis Research, Inc
Salt Lake City, Utah, 84109
J. Lewis Research, Inc
Salt Lake City, Utah, 84121
University Of California, San Francisco
San Francisco, California, 94115
California Medical Clinic For Headache
Santa Monica, California, 90404
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Swedish Pain And Headache Center
Seattle, Washington, 98104
Encompass Clinical Research
Spring Valley, California, 91978
Clinvest/ A Division Of Banyan Group, Inc.
Springfield, Missouri, 65807
Mercy Health Research
St Louis, Missouri, 63141
Comprehensive Clinical Development, Inc
St. Petersburg, Florida, 33716
Clinical Res. Advantage Inc/ Desert Clinical Research Llc
Tempe, Arizona, 85282
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Omega Medical Research
Warwick, Rhode Island, 02886
Medvadis Research Corporation
Watertown, Massachusetts, 02472-3930
Pmg Research Of Winston-Salem
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Phase IIb: Double-Blind, Randomized, Placebo Controlled, Dose-ranging Trial of BMS-927711 for the Acute Treatment of Migraine

Read the detailed description

Intervention Model: Parallel Versus Comparator + Placebo

Conditions: Migraine, Acute Treatment of Migraine
Being tested: Rimegepant, Placebo, Sumatriptan
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RimegepantDrug
Rimegepant capsules
PlaceboDrug
Rimegepant placebo-matching capsules
SumatriptanDrug
Also called Imitrex®
Rimegepant matching sumatriptan and Rimegepant matching placebo capsules

Study groups in NCT01430442
Study group	Role	What they receive
Treatment A: Rimegepant, 10 mg	Experimental	Participants received a single dose (one capsule) of rimegepant 10 milligram (mg) orally and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. Receives: Drug: Rimegepant; Drug: Placebo
Treatment B: Rimegepant, 25 mg	Experimental	Participants received a single dose (one capsule) of rimegepant 25 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. Receives: Drug: Rimegepant; Drug: Placebo
Treatment C: Rimegepant, 75 mg	Experimental	Participants received a single dose (one capsule) of rimegepant 75 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. Receives: Drug: Rimegepant; Drug: Placebo
Treatment D: Rimegepant, 150 mg	Experimental	Participants received a single dose (one capsule) of rimegepant 150 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. Receives: Drug: Rimegepant; Drug: Placebo
Treatment E: Rimegepant, 300 mg	Experimental	Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. Receives: Drug: Rimegepant; Drug: Placebo
Treatment F: Rimegepant, 600 mg	Experimental	Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally; anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity. Receives: Drug: Rimegepant; Drug: Placebo
Treatment P: Rimegepant Placebo-Matching Capsules	Placebo comparator	Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. Receives: Drug: Placebo
Treatment G: Sumatriptan 100 mg	Active comparator	Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three rimegepant matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity. Receives: Drug: Placebo; Drug: Sumatriptan

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose
Pain freedom was defined as participants reporting a value of "none" on the four-point numeric rating scale (none=0, mild =1, moderate =2, severe =3) from baseline. Participants with baseline moderate pain or severe pain were included in the analysis.
Measured: Baseline, 2 hours post-dose

Secondary outcomes (4)

Number of Participants With Total Migraine Freedom at 2 Hours Post Dose
Total migraine freedom is defined as complete absence of migraine symptoms. A participant was positive for total migraine freedom at a particular time point if he/she reports the absence of: pain, nausea, photophobia, and phonophobia. This corresponds to reporting "none" on each of the four-point numeric rating scale (none =0, mild =1, moderate =2, severe =3) from baseline associated with these symptoms. Participants with baseline moderate pain or severe pain were included in the analysis.
Measured: Baseline, 2 hours post dose
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition, unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or suspected transmission of an infectious agent, or encompassed any other clinically significant event that could jeopardize the subject or require medical or surgical intervention to prevent one of the aforementioned outcomes.
Measured: AEs: from first dose to end of treatment visit (up to 7 weeks); SAE: from signing of informed consent to 30 days after the last dose (up to 11 weeks).
Number of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours Post Dose
Participants were considered to have sustained pain freedom if all of their reported pain readings in the interval are "none" on the four point numeric rating scale (no pain=0, mild pain=1, moderate pain=2, severe pain=3). The intervals are inclusive of the endpoints. Sustained pain freedom was analyzed with a Cochran Mantel Haenszel (CMH) test for general association that compares the ED90 to placebo, and controls for baseline pain severity.
Measured: 2 hours to 24 hours post dose
Number of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours Post Dose
Participants were considered to have sustained pain freedom if all of their reported pain readings in the interval are "none" on the four point numeric rating scale (no pain=0, mild pain=1, moderate pain=2, severe pain=3). The intervals are inclusive of the endpoints. Sustained pain freedom was analyzed with a CMH test for general association that compares the ED90 to placebo, and controls for baseline pain severity.
Measured: 2 hours to 48 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011May 2012

First posted8 Sep 2011 (estimated)
Study startOct 2011
Primary completionMay 2012
Study completionMay 2012

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MigraineStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,026 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01430442
Sponsor's protocol ID: CN170-003
Status last verified: Dec 2022
First submitted: 7 Sep 2011
Last updated: 28 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Marcus R, Goadsby PJ, Dodick D, Stock D, Manos G, Fischer TZ. BMS-927711 for the acute treatment of migraine: a double-blind, randomized, placebo controlled, dose-ranging trial. Cephalalgia. 2014 Feb;34(2):114-25. doi: 10.1177/0333102413500727. Epub 2013 Aug 21.
PubMed 23965396

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IIb: Double-Blind, Randomized, Placebo Controlled, Dose-ranging Trial of BMS-927711 for the Acute Treatment of Migraine
ClinicalTrials.gov ID: NCT01430442
Acronym / sponsor ID: CN170-003
Conditions: Migraine, Acute Treatment of Migraine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,026 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2011 (actual)
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 8 Sep 2011 (estimated)
Results: Posted 3 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Intervention Model: Parallel Versus Comparator + Placebo

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Treatment A: Rimegepant, 10 mg	Experimental	Drug: Rimegepant, Drug: PlaceboParticipants received a single dose (one capsule) of rimegepant 10 milligram (mg) orally and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Treatment B: Rimegepant, 25 mg	Experimental	Drug: Rimegepant, Drug: PlaceboParticipants received a single dose (one capsule) of rimegepant 25 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Treatment C: Rimegepant, 75 mg	Experimental	Drug: Rimegepant, Drug: PlaceboParticipants received a single dose (one capsule) of rimegepant 75 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Treatment D: Rimegepant, 150 mg	Experimental	Drug: Rimegepant, Drug: PlaceboParticipants received a single dose (one capsule) of rimegepant 150 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Treatment E: Rimegepant, 300 mg	Experimental	Drug: Rimegepant, Drug: PlaceboParticipants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Treatment F: Rimegepant, 600 mg	Experimental	Drug: Rimegepant, Drug: PlaceboParticipants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally; anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Treatment P: Rimegepant Placebo-Matching Capsules	Placebo comparator	Drug: PlaceboParticipants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
Treatment G: Sumatriptan 100 mg	Active comparator	Drug: Placebo, Drug: SumatriptanParticipants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three rimegepant matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patient with at least 1-year history of migraines (with or without aura) including the following:
Male and female ≥ 18 years and ≤ age 65
No clinically significant abnormality identified on the medical or laboratory evaluation

Key exclusion criteria (5 listed)

Patient has a history of basilar migraine or hemiplegic migraine
Patient does not receive migraine relief from triptan migraine treatment
Medications that may alter the pH of the stomach (acid reducing agents), such as H-2 antagonists, Proton Pump inhibitors (PPI), antacids
History of ergotamine or triptan intake greater than/equal 10 days per month on a regular basis for greater than 3 months
History of non-narcotic analgesic intake on greater then/equal 15 days per month for greater than/equal 3 months

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
RimegepantRimegepant capsules	Drug	Treatment A: Rimegepant, 10 mg, Treatment B: Rimegepant, 25 mg, Treatment C: Rimegepant, 75 mg, Treatment D: Rimegepant, 150 mg, Treatment E: Rimegepant, 300 mg, Treatment F: Rimegepant, 600 mg
PlaceboRimegepant placebo-matching capsules	Drug	Treatment A: Rimegepant, 10 mg, Treatment B: Rimegepant, 25 mg, Treatment C: Rimegepant, 75 mg, Treatment D: Rimegepant, 150 mg, Treatment E: Rimegepant, 300 mg, Treatment F: Rimegepant, 600 mg, Treatment G: Sumatriptan 100 mg, Treatment P: Rimegepant Placebo-Matching Capsules
SumatriptanAlso: Imitrex®Rimegepant matching sumatriptan and Rimegepant matching placebo capsules	Drug	Treatment G: Sumatriptan 100 mg

Primary outcome

Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose
Time frame: Baseline, 2 hours post-dose
Pain freedom was defined as participants reporting a value of "none" on the four-point numeric rating scale (none=0, mild =1, moderate =2, severe =3) from baseline. Participants with baseline moderate pain or severe pain were included in the analysis.

4 secondary outcomes

Number of Participants With Total Migraine Freedom at 2 Hours Post Dose
Time frame: Baseline, 2 hours post dose
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events
Time frame: AEs: from first dose to end of treatment visit (up to 7 weeks); SAE: from signing of informed consent to 30 days after the last dose (up to 11 weeks).
Number of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours Post Dose
Time frame: 2 hours to 24 hours post dose
Number of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours Post Dose
Time frame: 2 hours to 48 hours post dose

Results and safety

Results posted to the registry on 3 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A: Rimegepant, 10 mg	85	72
Treatment B: Rimegepant, 25 mg	68	62
Treatment C: Rimegepant, 75 mg	91	86
Treatment D: Rimegepant, 150 mg	90	86
Treatment E: Rimegepant, 300 mg	121	112
Treatment F: Rimegepant, 600 mg	92	84
Treatment P: Rimegepant Placebo-Matching Capsules	229	210
Treatment G: Sumatriptan 100 mg	109	100

Primary outcome: Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose

Time frame: Baseline, 2 hours post-dose. Count of participants. Unit: Participants

Measure	Treatment A: Rimegepant, 10 mg n = 71	Treatment B: Rimegepant, 25 mg n = 61	Treatment C: Rimegepant, 75 mg n = 86	Treatment D: Rimegepant, 150 mg n = 85	Treatment E: Rimegepant, 300 mg n = 111	Treatment F: Rimegepant, 600 mg n = 82	Treatment P: Rimegepant Placebo-Matching Capsules n = 203	Treatment G: Sumatriptan 100 mg n = 100
Value	14	12	27	28	33	20	31	35

Population analysed: Efficacy population - all participants who took study medication with 1 post-randomization efficacy evaluation and a corresponding baseline pain evaluation for the treated headache. Participants with mild baseline pain are excluded.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs: from first dose to end of treatment visit (up to 52 days); SAE: from signing of informed consent to 30 days after the last dose (up to 80 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A: Rimegepant, 10 mg	0 of 72 (0%)	4 of 72 (5.6%)	0 of 85
Treatment B: Rimegepant, 25 mg	0 of 62 (0%)	0 of 62 (0%)	0 of 68
Treatment C: Rimegepant, 75 mg	0 of 86 (0%)	3 of 86 (3.5%)	0 of 91
Treatment D: Rimegepant, 150 mg	3 of 86 (3.5%)	3 of 86 (3.5%)	0 of 90
Treatment E: Rimegepant, 300 mg	0 of 112 (0%)	6 of 112 (5.4%)	0 of 121
Treatment F: Rimegepant, 600 mg	0 of 84 (0%)	7 of 84 (8.3%)	0 of 92
Treatment P: Rimegepant Placebo-Matching Capsules	0 of 209 (0%)	5 of 209 (2.4%)	0 of 229
Treatment G: Sumatriptan 100 mg	0 of 100 (0%)	2 of 100 (2%)	0 of 109

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23965396Marcus R, Goadsby PJ, Dodick D, Stock D, Manos G, Fischer TZ. BMS-927711 for the acute treatment of migraine: a double-blind, randomized, placebo controlled, dose-ranging trial. Cephalalgia. 2014 Feb;34(2):114-25. doi: 10.1177/0333102413500727. Epub 2013 Aug 21.

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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.

41 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rimegepant and Sumatriptan in people with Migraine and Acute Treatment of Migraine, run by Pfizer at 41 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 8 inclusion and 5 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 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 3 Sep 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?

Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose (time frame: Baseline, 2 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01430442, which also lists 1 linked publication.

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 28 Feb 2023.