Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine (ACHIEVE II)

March 1, 2019 updated by: Allergan

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Single Attack Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25 and 50 mg) compared to placebo for the acute treatment of a single migraine attack.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1686

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Clinical Research Advantage, Inc./Simon Williamson Clinic
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Clinical Research Advantage, Inc./East Valley Family Physicians, PLC
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital & Medical Center - Barrow Neurologic Institute (BNI)
      • Phoenix, Arizona, United States, 85020
        • Clinical Research Advantage, Inc./Central Phoenix Medical Clinic, LLC
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Arizona, May Clinic Scottsdale
      • Tucson, Arizona, United States, 85712
        • Radiant Research Inc.
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials, LLC
      • Apple Valley, California, United States, 92307
        • Axiom Research, LLC
      • Canoga Park, California, United States, 91303
        • HOPE Clinical Research
      • Colton, California, United States, 92324
        • Axiom Research, LLC
      • Encino, California, United States, 91316
        • Pharmacology Research Institute
      • Fresno, California, United States, 93710
        • Neuro-Pain Medical Center
      • Fresno, California, United States, 93720
        • California Headache and Balance Center
      • Imperial, California, United States, 92251
        • Sun Valley Research Center
      • La Mesa, California, United States, 91942
        • Grossmont Center for Clinical Research
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute
      • Los Angeles, California, United States, 90024
        • California Advanced Neurotherapeutic, Inc.
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Pain Center
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute
      • Rancho Cucamonga, California, United States, 91730
        • Rancho Cucamonga Clinical Research
      • Rancho Mirage, California, United States, 92270
        • Desert Valley Research
      • Redondo Beach, California, United States, 90277
        • George J Rederich MD, Inc
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
      • Vista, California, United States, 92083
        • Clinical Research Advantage, Inc./Cassidy Medical Group-Vista
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • Clinicos, LLC
      • Englewood, Colorado, United States, 80113
        • Colorado Neurological Institute
      • Fort Collins, Colorado, United States, 80528
        • Advanced Neurosciences Research, LLC
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital
      • Washington, District of Columbia, United States, 20016
        • Radiant Clinical Research
    • Florida
      • Aventura, Florida, United States, 33180
        • Aventura Neurological Associates
      • Coral Gables, Florida, United States, 33134
        • Clinical Research South Florida
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research, LLC
      • Hollywood, Florida, United States, 33024
        • Broward Research Group
      • Jupiter, Florida, United States, 33458
        • Health Awareness, Inc.
      • Maitland, Florida, United States, 32751
        • Neurology Associates, P.A.
      • Miami, Florida, United States, 33126
        • LCC Medical Research Institute, LLC
      • Miami, Florida, United States, 33143
        • Well Pharma Medical Research, Corp.
      • Miami Lakes, Florida, United States, 33014
        • Panax Clinical Research
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
      • Ocoee, Florida, United States, 34761
        • Sensible Healthcare, LLC
      • South Miami, Florida, United States, 33143
        • QPS MRA, LLC (Miami Research Associates)
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • The Kaufmann Clinic, Inc.
      • Atlanta, Georgia, United States, 30342
        • NeuroTrials Research, Inc.
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Cedar Crosse Research Center
      • Chicago, Illinois, United States, 60604
        • Clinical Research Advantage, Inc./Michigan Avenue Internists
      • Riverwoods, Illinois, United States, 60015
        • Robbins Headache Clinic
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Josephson Wallack Munshower Neurology P.C.
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
      • Louisville, Kentucky, United States, 40207
        • Norton Neurology Services MS Services
    • Maryland
      • Baltimore, Maryland, United States, 21228
        • Seton Medical Group
      • Baltimore, Maryland, United States, 21236
        • Overlea Personal Physicians
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
        • Btc of New Bedford
      • Quincy, Massachusetts, United States, 02169
        • Beacon Clinical Research, LLC
      • Worcester, Massachusetts, United States, 01605
        • New England Regional Headache Center, Inc.
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Quest Research Institute
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
        • Minneapolis Clinic of Neurology
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • The Headache Center
    • Nebraska
      • Fremont, Nebraska, United States, 68025
        • Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC
      • Omaha, Nebraska, United States, 68134
        • Meridian Clinical Research, LLC
      • Omaha, Nebraska, United States, 68114
        • Clinical Research Advantage, Inc
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • HOPE Research Institute
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Princeton Medical Institute
      • Skillman, New Jersey, United States, 08558
        • Princeton Center For Clinical Research
      • Toms River, New Jersey, United States, 08755
        • Bio Behavioral Health
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurosciences Research Center
      • Great Neck, New York, United States, 11021
        • Cushing Neuroscience Institute North Shore-LIJ Medical Group
      • Plainview, New York, United States, 11803
        • ProHEALTH CARE Associates, LLP
      • Williamsville, New York, United States, 14221
        • Upstate Clinical Research Associates, LLC
      • Yonkers, New York, United States, 10701
        • Westchester Neuro. Const
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Carolina Headache Institute
      • Greensboro, North Carolina, United States, 27405
        • Headache Wellness Center, PC
      • Mooresville, North Carolina, United States, 28117
        • Lake Shore Clinical Research, LLC
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates, Pa
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Plains Clinical Research Center, LLC
    • Ohio
      • Akron, Ohio, United States, 44311
        • Radiant Research, Inc.
      • Cincinnati, Ohio, United States, 45227
        • CTI Clinical Research Center
      • Cincinnati, Ohio, United States, 45215
        • Patient Priority Clinical Sites, LLC
      • Cincinnati, Ohio, United States, 45212
        • Sentral Clinical Research Services
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Dept of Psychiatry & Behavioral Neuroscience
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Sooner Clinical Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15236
        • Preferred Primary Care Physicians, Inc.
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians
      • Willow Grove, Pennsylvania, United States, 19090
        • Abington Neurological Associates, Ltd.
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Radiant Research, Inc.
      • Charleston, South Carolina, United States, 29406
        • Clinical Trials of South Carolina
      • Columbia, South Carolina, United States, 29201
        • Vista Clinical Research
      • Simpsonville, South Carolina, United States, 29681
        • Hillcrest Clinical Research, LLC
    • Tennessee
      • Fayetteville, Tennessee, United States, 37334
        • Middle Tennessee Clinical Research
      • Knoxville, Tennessee, United States, 37920
        • Volunteer Research Group
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Medical Group (Neurology Specialist - Headache Clinic)
    • Texas
      • Dallas, Texas, United States, 75214
        • Texas Neurology, P.A.
      • Dallas, Texas, United States, 75234
        • Radiant Research, Inc
      • Humble, Texas, United States, 77338
        • Research Trials Worldwide, LLC
    • Utah
      • Ogden, Utah, United States, 84403
        • Advanced Research Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research Center, LLC
      • McLean, Virginia, United States, 22102
        • iNeuro Headache Specialist
      • Norfolk, Virginia, United States, 23507
        • Clinical Research Associates of Tidewater
      • Roanoke, Virginia, United States, 24018
        • Blue Ridge Research Center, LLC
      • Virginia Beach, Virginia, United States, 23456
        • Sentara Neurology Specialists
    • Washington
      • Seattle, Washington, United States, 98104
        • Summit Research Network Seattle, LLC
      • Tacoma, Washington, United States, 98409
        • South Puget Sound Neurology
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University, Department of Neurology
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin, Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition, beta version
  • Migraine onset before age 50
  • History of migraines typically lasting between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom
  • History of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the previous 3 months.

Exclusion Criteria:

  • Difficulty distinguishing migraine headache from tension-type other headaches
  • Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs], triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per month in the previous 3 months
  • Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine
  • Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
  • Required hospital treatment of a migraine attack 3 or more times in the previous 6 months
  • Has a chronic non-headache pain condition requiring daily pain medication
  • Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • Has a history of any prior gastrointestinal conditions (eg, diarrhoea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded
  • Has a history of hepatitis within previous 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ubrogepant 25 mg
1 ubrogepant 25 milligram (mg) tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Drug: Ubrogepant
Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Drug: Placebo-matching Ubrogepant
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Experimental: Ubrogepant 50 mg
1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Drug: Ubrogepant
Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Drug: Placebo-matching Ubrogepant
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Placebo Comparator: Placebo
1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Drug: Placebo-matching Ubrogepant
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose
Time Frame: Baseline (Predose) to 2 hours after initial dose
Pain freedom was defined as a reduction in headache pain severity from moderate/severe at baseline to no pain at 2 hours after the initial dose of investigational product. Participants were provided with electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.
Baseline (Predose) to 2 hours after initial dose
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose
Time Frame: Baseline (Predose) to 2 hours after initial dose
The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms assessed.
Baseline (Predose) to 2 hours after initial dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose
Time Frame: Baseline (Predose) to 2 hours after initial dose
Pain relief was defined as a reduction of a moderate/severe migraine headache to a mild headache or to no headache. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing pain severity assessment at or before 2 hours after initial dose.
Baseline (Predose) to 2 hours after initial dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose
Time Frame: 2 to 24 hours after initial dose
Sustained pain relief was defined as a pain relief at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with assessment of determinable sustained pain relief from 2 to 24 hours after initial dose.
2 to 24 hours after initial dose
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose
Time Frame: 2 to 24 hours after initial dose
Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with assessment of determinable sustained pain freedom from 2 to 24 hours after initial dose.
2 to 24 hours after initial dose
Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose
Time Frame: 2 hours after initial dose
Photophobia was defined as sensitivity to light, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence photophobia. Number analyzed is the number of participants with non-missing postdose photophobia assessment at or before 2 hours after initial dose.
2 hours after initial dose
Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose
Time Frame: 2 hours after initial dose
Phonophobia was defined as sensitivity to sound, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of phonophobia. Number analyzed is the number of participants with non-missing postdose phonophobia assessment at or before 2 hours after initial dose.
2 hours after initial dose
Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose
Time Frame: 2 hours after initial dose
Nausea was a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of nausea. Number analyzed is the number of participants with non-missing postdose nausea assessment at or before 2 hours after initial dose.
2 hours after initial dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Adele Thorpe, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 26, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UBR-MD-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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