Study to Evaluate the Safety and Tolerability of Treatmen... | NCT03700320

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oral SOC Migraine Preventive Medication	Active Comparator	Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.	Drug: Standard of Care (SOC) Migraine Preventive Medication
Atogepant 60 mg	Experimental	Atogepant 60 mg tablet taken orally, once daily for 52 weeks.	Drug: Atogepant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard of Care (SOC) Migraine Preventive Medication	Drug	Standard of care medication selected based on investigator's judgement, recognized as safe and effective for the prevention of migraine.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving investigational study drug.	From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator	Laboratory tests included tests of hematology, chemistry, and urinalysis. The investigator determined if the results were potentially clinically significant (PCS). Only categories with at least one participant are reported.	From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent and participant privacy information (e.g., written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.
Participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral SOC migraine prevention medications and the participant is willing to accept SOC treatment.
Participants must be using a medically acceptable and effective method of birth control during the course of the entire study,
At least a 1-year history of migraine with or without aura consistent with a diagnosis
Age of the participant at the time of migraine onset < 50 years
History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1

Exclusion Criteria:

Difficulty distinguishing migraine headaches from tension-type or other headaches
Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine
Has a current diagnosis of chronic migraine (CM), new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy
≥ 15 headache days per month on average across the 3 months prior to Visit 1
Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment, or during the baseline period. For all participants, barbiturates are excluded 30 days prior to screening and during the baseline period. For participants randomized to atogepant, barbiturates are excluded through the duration of the study as well
Female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test
Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal (GI), or neurologic disease
Hypertension as defined by sitting systolic blood pressure (BP) > 160 millimeter of mercury (mm Hg) or sitting diastolic BP > 100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may be repeated only once.
At Visit 1, a user of recreational or illicit drugs or has had a history within the past year of drug or alcohol abuse or dependence
History of any GI prior procedures or GI conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed are not excluded.

Name	Affiliation	Role
Joel Trugman, MD	Allergan	Study Director

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39648629	Derived	Peterlin BL, Bond DS, Ailani J, Dodick DW, Liu Y, De Abreu Ferreira R, Smith JH, Dabruzzo B, Goadsby PJ, Trugman JM. Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis. Cephalalgia. 2024 Dec;44(12):3331024241299753. doi: 10.1177/03331024241299753.
38773375	Derived	Lipton RB, Nahas SJ, Pozo-Rosich P, Bilchik T, McAllister P, Finnegan M, Liu Y, Chalermpalanupap N, Dabruzzo B, Dodick DW. Sustained response to atogepant in episodic migraine: post hoc analyses of a 12-week randomized trial and a 52-week long-term safety trial. J Headache Pain. 2024 May 21;25(1):83. doi: 10.1186/s10194-024-01783-6.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Oral SOC Migraine Preventive Medication	Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
FG001	Atogepant 60 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	Apr 24, 2020	May 20, 2021

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
	BG00041.1± 12.09 BG00142.5± 12.03 BG00242.2± 12.05

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000172 BG001479 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00029 BG00183 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0013 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 at Least 1 Treatment Emergent Adverse Event (TEAE)

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving investigational study drug.

Safety Population included all participants who received ≥1 dose of study intervention.

Posted

Number

percentage of participants

From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up

ID	Title	Description
OG000	Oral SOC Migraine Preventive Medication	Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
OG001	Atogepant 60 mg	Atogepant 60 mg tablet taken orally, once daily for 52 weeks.

Units	Counts
Participants	OG000196 OG001543

Title

Denominators

Categories

Title	Measurements
	OG00078.6 OG00167.0

Secondary

Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator

Laboratory tests included tests of hematology, chemistry, and urinalysis. The investigator determined if the results were potentially clinically significant (PCS). Only categories with at least one participant are reported.

Safety Population included all participants who received ≥1 dose of study intervention. Number analyzed is the number of participants with non-missing non-PCS baseline value and ≥1 post-baseline parameter assessment.

Posted

Number

percentage of participants

From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up

ID	Title	Description
OG000	Oral SOC Migraine Preventive Medication	Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
OG001	Atogepant 60 mg	Atogepant 60 mg tablet taken orally, once daily for 52 weeks.

Units	Counts
Participants

Secondary

Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator

A standard 12-lead ECG was performed. The investigator determined if the result was potentially clinically significant. Only categories with at least one participant are reported.

Posted

Number

percentage of participants

Up to Week 52

ID	Title	Description
OG000	Oral SOC Migraine Preventive Medication	Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
OG001	Atogepant 60 mg	Atogepant 60 mg tablet taken orally, once daily for 52 weeks.

Units	Counts
Participants

Secondary

Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator

Vital sign measurements included sitting and standing blood pressure (BP), sitting and standing pulse rate, respiratory rate, temperature, and body weight. The investigator determined if the results were clinically significant. Only categories with at least one participant are reported.

Posted

Number

percentage of participants

From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up)

ID	Title	Description
OG000	Oral SOC Migraine Preventive Medication	Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
OG001	Atogepant 60 mg	Atogepant 60 mg tablet taken orally, once daily for 52 weeks.

Units	Counts
Participants

Secondary

Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior

The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior). Only the most severe suicidal ideation and the most severe suicidal behavior counted during the treatment period for at least 1 participant are reported.

Safety Population included all participants who received ≥1 dose of study intervention.

Posted

Count of Participants

Participants

Up to Week 52

ID	Title	Description
OG000	Oral SOC Migraine Preventive Medication	Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
OG001	Atogepant 60 mg

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Vertigo	Ear and labyrinth disorders	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Non-cardiac chest pain	General disorders	MedDRA Version 22.0	Systematic Assessment		EG0002 affected196 at risk EG0010 affected543 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Beta haemolytic streptococcal infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Corona virus infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Pneumonia	Infections and infestations	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Sepsis	Infections and infestations	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA Version 22.0	Systematic Assessment		EG0001 affected196 at risk EG0010 affected543 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Neuroendocrine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Systematic Assessment	Number of participants at risk are female participants as this adverse event is specific to females.	EG0000 affected172 at risk EG0011 affected479 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Systematic Assessment		EG0001 affected196 at risk EG0010 affected543 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Epilepsy	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Migraine	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Status migrainosus	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.0	Systematic Assessment		EG0001 affected196 at risk EG0010 affected543 at risk
Transient global amnesia	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Device malfunction	Product Issues	MedDRA Version 22.0	Systematic Assessment		EG0001 affected196 at risk EG0010 affected543 at risk
Anxiety	Psychiatric disorders	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Suicidal behaviour	Psychiatric disorders	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Suicide attempt	Psychiatric disorders	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Suicidal ideation	Psychiatric disorders	MedDRA Version 22.0	Systematic Assessment		EG0001 affected196 at risk EG0010 affected543 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA Version 22.0	Systematic Assessment	Number of participants at risk are female participants as this adverse event is specific to females.	EG0000 affected172 at risk EG0011 affected479 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA Version 22.0	Systematic Assessment	Number of participants at risk are female participants as this adverse event is specific to females.	EG0000 affected172 at risk EG0011 affected479 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Lung perforation	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Victim of crime	Social circumstances	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk
Victim of homicide	Social circumstances	MedDRA Version 22.0	Systematic Assessment		EG0000 affected196 at risk EG0011 affected543 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG0006 affected196 at risk EG00139 affected543 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 22.0	Systematic Assessment	EG00012 affected196 at risk EG00134 affected543 at risk
Fatigue	General disorders	MedDRA Version 22.0	Systematic Assessment	EG00012 affected196 at risk EG00114 affected543 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG00024 affected196 at risk EG00156 affected543 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG0009 affected196 at risk EG00128 affected543 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 22.0	Systematic Assessment	EG00010 affected196 at risk EG00124 affected543 at risk
Weight increased	Investigations	MedDRA Version 22.0	Systematic Assessment	EG00011 affected196 at risk EG0017 affected543 at risk
Dizziness	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment	EG00022 affected196 at risk EG00117 affected543 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 22.0	Systematic Assessment	EG00012 affected196 at risk EG0018 affected543 at risk
Anxiety	Psychiatric disorders	MedDRA Version 22.0	Systematic Assessment	EG00011 affected196 at risk EG00115 affected543 at risk

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

ID	Title	Description
BG000	Oral SOC Migraine Preventive Medication	Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
BG001	Atogepant 60 mg	Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Oral SOC Migraine Preventive Medication	Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.	0	198	7	196	91	196
EG001	Atogepant 60 mg	Atogepant 60 mg tablet taken orally, once daily for 52 weeks.	2	546	24	543	197	543