Migraine, With or Without Aura Clinical Trial
Official title:
A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety, And Tolerability Of Multiple Dosing Regimens Of Oral AGN-241689 In Episodic Migraine Prevention
| Verified date | November 2018 |
| Source | Allergan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will evaluate the safety and tolerability of the following doses of atogepant (AGN-241689): 10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the prevention of episodic migraine and will characterize the dose/response relationship.
| Status | Completed |
| Enrollment | 834 |
| Est. completion date | April 23, 2018 |
| Est. primary completion date | April 2, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Has at least a 1-year history of migraine with or without aura - Age of the patient at the time of migraine onset < 50 years - History of 4 to 14 migraine days (migraine/probable migraine headache days) per month on average in the 3 months prior to Visit 1 in the Investigator's judgment - Demonstrated compliance with e-diary Exclusion Criteria: - Has a history of migraine accompanied by diplopia or decreased level of consciousness and retinal migraine - Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy - Difficulty distinguishing migraine headache from other headaches - 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 gastric or small intestinal surgery, or has a disease that causes malabsorption - Has a history of hepatitis within previous 6 months - Usage of opioids or barbiturates > 2 days/month, triptans or ergots = 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) = 15 days/month in the 3 months prior to Visit 1 - Pregnant or nursing females |
| Country | Name | City | State |
|---|---|---|---|
| United States | Lehigh Center For Clinical Research | Allentown | Pennsylvania |
| United States | Institute for Advanced Medical Research | Alpharetta | Georgia |
| United States | DENT Neurosciences Research Center | Amherst | New York |
| United States | Michigan Head Pain and Neurological Institute | Ann Arbor | Michigan |
| United States | Atlanta Center for Medical Research | Atlanta | Georgia |
| United States | Radiant Research | Atlanta | Georgia |
| United States | DermResearch Inc | Austin | Texas |
| United States | Tekton Research | Austin | Texas |
| United States | Northwest Clinical Research Center | Bellevue | Washington |
| United States | Hassman Research Institute - NJ | Berlin | New Jersey |
| United States | Achieve Clinical Research | Birmingham | Alabama |
| United States | Healthcare Research Network II, LLC | Blue Island | Illinois |
| United States | Northwest Clinical Trials, Inc. | Boise | Idaho |
| United States | Boston Clinical Trials Inc | Boston | Massachusetts |
| United States | DiscoveResearch, Inc. | Bryan | Texas |
| United States | The Research Center of Southern California, LLC | Carlsbad | California |
| United States | Radiant Research, Inc. | Chandler | Arizona |
| United States | Clinical Research South Florida | Coral Gables | Florida |
| United States | Synexus US, L.P. Formally known as Texas Pharmaceutical Research, LP, DBA Research Across America | Dallas | Texas |
| United States | iResearch Atlanta, LLC | Decatur | Georgia |
| United States | Carolina Headache Institute | Durham | North Carolina |
| United States | Hartford Headache Center | East Hartford | Connecticut |
| United States | Associated Neurologists of Southern Connecticut, P. C. | Fairfield | Connecticut |
| United States | Advanced Neurosciences Research | Fort Collins | Colorado |
| United States | Neuro-Pain Medical Center, Inc | Fresno | California |
| United States | Infinity Clinical Research | Hollywood | Florida |
| United States | Irvine Center for Clinical Research | Irvine | California |
| United States | Clinical Neuroscience Solutions Inc | Jacksonville | Florida |
| United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
| United States | Radiant Research, Inc. | Jamaica | New York |
| United States | Altea Research Institute | Las Vegas | Nevada |
| United States | Rowe Neurology Institute | Lenexa | Kansas |
| United States | Downtown LA Research Center, Inc. | Los Angeles | California |
| United States | Meridien Research | Maitland | Florida |
| United States | Suburban Research Associates | Media | Pennsylvania |
| United States | Cns Healthcare | Memphis | Tennessee |
| United States | Suncoast Research | Miami | Florida |
| United States | Clinical Research Institute, Inc. | Minneapolis | Minnesota |
| United States | Coastal Carolina Research Center | Mount Pleasant | South Carolina |
| United States | Nashville Neuroscience Group | Nashville | Tennessee |
| United States | Northeast Medical Research Associates, Inc. | North Dartmouth | Massachusetts |
| United States | Renstar Medical Research | Ocala | Florida |
| United States | Excell Research | Oceanside | California |
| United States | IPS Research Company | Oklahoma City | Oklahoma |
| United States | Lynn Health Science Institute | Oklahoma City | Oklahoma |
| United States | Quality Clinical Research, Inc | Omaha | Nebraska |
| United States | Clinical Neuroscience Solutions | Orlando | Florida |
| United States | Palm Beach Neurological Center / Advanced Research Consultants, Inc. | Palm Beach Gardens | Florida |
| United States | Wake Research Associates LLC | Raleigh | North Carolina |
| United States | Renown Institute for Neuroscience | Reno | Nevada |
| United States | Central Texas Neurology Consultant | Round Rock | Texas |
| United States | Suncoast Neuroscience Associates, Inc. | Saint Petersburg | Florida |
| United States | Oregon Center for Clinical Investigations, Inc. | Salem | Oregon |
| United States | Radiant Research, San Antonio Center for Clinical Research | San Antonio | Texas |
| United States | Road Runner Research LTD | San Antonio | Texas |
| United States | Artemis Institute for Clinical Research | San Marcos | California |
| United States | Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology | Sandy Springs | Georgia |
| United States | Women's Clinical Research Center | Seattle | Washington |
| United States | Kingfisher Cooperative, LLC | Spokane | Washington |
| United States | Clinvest | Springfield | Missouri |
| United States | Mercy Research | Springfield | Missouri |
| United States | Clinical Research Atlanta | Stockbridge | Georgia |
| United States | Infinity Clinical Research LLC | Sunrise | Florida |
| United States | Meridien Research | Tampa | Florida |
| United States | Tidewater Integrated Medical Research | Virginia Beach | Virginia |
| United States | Diablo Clinical Research Inc | Walnut Creek | California |
| United States | Amici Clinical Research | Warren | New Jersey |
| United States | The George Washington University | Washington | District of Columbia |
| United States | Chase Medical Research, LLC | Waterbury | Connecticut |
| United States | Medvadis Research Corporation | Watertown | Massachusetts |
| United States | ClinPoint Trials, LLC | Waxahachie | Texas |
| United States | Advanced Clinical Research | West Jordan | Utah |
| United States | Neurology Research Institute Palm Beach | West Palm Beach | Florida |
| United States | Ohio Clinical Research, LLC | Willoughby Hills | Ohio |
| United States | New England Regional Headache Center | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Allergan |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period | Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4- week period and multiplied by 28. Each 4-week period was averaged. Negative change from Baseline indicates improvement. | Baseline (First 28 Days of Screening/Baseline Period) to Week 12 | |
| Secondary | Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period | Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache qualified by duration and acute symptomatic medication use. The 4-week (monthly) headache days was defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Negative change from Baseline indicates improvement. | Baseline (First 28 Days of Screening/Baseline Period) to Week 12 | |
| Secondary | Percentage of Participants With at Least a 50% Reduction in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period | Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days=total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. Each 4-week period was averaged. | Baseline (First 28 Days of Screening/Baseline Period) to Week 12 | |
| Secondary | Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period | Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The 4-week (monthly) acute medication use days was defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. A negative change from Baseline indicates improvement. | Baseline (First 28 Days of Screening/Baseline Period) to Week 12 |
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