Efficacy, Safety, and Tolerability of Oral Ubrogepant in... | NCT02867709

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ubrogepant 25 mg	Experimental	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 Drug: Placebo-matching Ubrogepant
Ubrogepant 50 mg	Experimental	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 Drug: Placebo-matching Ubrogepant
Placebo	Placebo Comparator	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

Name	Type	Description	Arm Group Labels	Other Names
Ubrogepant	Drug	Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.	Ubrogepant 25 mg Ubrogepant 50 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Pain Freedom at 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	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 Outcomes

Measure	Description	Time Frame
Percentage of Participants With Pain Relief at 2 Hours After the 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.

Eligibility Module

Name	Affiliation	Role
Adele Thorpe	Allergan	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Advantage, Inc./Simon Williamson Clinic		Birmingham	Alabama	35211	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39982105	Derived	Goadsby PJ, Jurgens TP, Brand-Schieber E, Nagy K, Liu Y, Boinpally R, Stodtmann S, Trugman JM. Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials. Cephalalgia. 2025 Feb;45(2):3331024251320610. doi: 10.1177/03331024251320610.
36125279	Derived

Label	URL
More Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	Ubrogepant 25 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 19, 2017	Jan 9, 2019

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	Ubrogepant 25 mg	1 ubrogepant 25 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.
BG002	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.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00041.5± 12.2 BG00141.6± 12.3 BG00241.0± 12.4 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000494 BG001501 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG000449 BG001467 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG000116 BG001129 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Pain Freedom at 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.

Modified Intent-to-Treat (mITT) population included all randomized participants who received at least 1 dose of study drug, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, last observation carried forward (LOCF).

Posted

Number

percentage of participants

Baseline (Predose) to 2 hours after initial dose

ID	Title	Description
OG000	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.
OG001	Ubrogepant 25 mg	1 ubrogepant 25 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.
OG002	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.

Units	Counts
Participants	OG000456 OG001435 OG002464

Title

Denominators

Categories

Title	Measurements
	OG00014.3 OG00120.7 OG00221.8

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic	Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.	0.0285	P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.	Odds Ratio (OR)	1.56			2-Sided	95	1.09	2.22					Superiority

Primary

Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 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.

mITT population included all randomized participants who received at least 1 dose of investigational product, recorded baseline migraine headache severity measurement, had ≥1 postdose migraine headache severity/migraine-associated symptom measurement at/before 2-hour timepoint, LOCF. Number analyzed is participants with data available for analysis.

Posted

Number

percentage of participants

Baseline (Predose) to 2 hours after initial dose

ID	Title	Description
OG000	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.
OG001	Ubrogepant 25 mg	1 ubrogepant 25 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.

Secondary

Percentage of Participants With Pain Relief at 2 Hours After the 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.

mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.

Posted

Number

percentage of participants

Baseline (Predose) to 2 hours after initial dose

ID	Title	Description
OG000	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.
OG001	Ubrogepant 25 mg	1 ubrogepant 25 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.
OG002

Secondary

Percentage of Participants With Sustained Pain Relief From 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.

Posted

Number

percentage of participants

2 to 24 hours after initial dose

ID	Title	Description
OG000	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.
OG001

Secondary

Percentage of Participants With Sustained Pain Freedom From 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.

Posted

Number

percentage of participants

2 to 24 hours after initial dose

ID	Title	Description
OG000	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.
OG001

Secondary

Percentage of Participants With the Absence of Photophobia at 2 Hours After the 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.

Posted

Number

percentage of participants

2 hours after initial dose

ID	Title	Description
OG000	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.
OG001	Ubrogepant 25 mg	1 ubrogepant 25 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.
OG002	Ubrogepant 50 mg

Secondary

Percentage of Participants With the Absence of Phonophobia at 2 Hours After the 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.

Posted

Number

percentage of participants

2 hours after initial dose

ID	Title	Description
OG000	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.
OG001	Ubrogepant 25 mg	1 ubrogepant 25 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.
OG002	Ubrogepant 50 mg

Secondary

Percentage of Participants With Absence of Nausea at 2 Hours After the 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.

Posted

Number

percentage of participants

2 hours after initial dose

ID	Title	Description
OG000	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.
OG001	Ubrogepant 25 mg	1 ubrogepant 25 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.
OG002	Ubrogepant 50 mg

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	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.	499	0	499	499
EG001	Ubrogepant 25 mg	1 ubrogepant 25 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.	478	1	478	478
EG002	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.	488	0	488	488

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ligament sprain	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected499 at risk EG0011 affected478 at risk EG0020 affected488 at risk
Loss of consciousness	Nervous system disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected499 at risk EG0011 affected478 at risk EG0020 affected488 at risk
Renal haematoma	Renal and urinary disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected499 at risk EG0011 affected478 at risk EG0020 affected488 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected499 at risk EG0011 affected478 at risk EG0020 affected488 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected499 at risk EG0011 affected478 at risk EG0020 affected488 at risk
Syncope	Nervous system disorders	MedDRA, version 20.1	Systematic Assessment	EG0000 affected499 at risk EG0011 affected478 at risk EG0020 affected488 at risk
Traumatic renal injury	Injury, poisoning and procedural complications	MedDRA, version 20.1	Systematic Assessment	EG0000 affected499 at risk EG0011 affected478 at risk EG0020 affected488 at risk

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases