Trial Outcomes & Findings for Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine (NCT NCT05216263)

Last Updated: 2026-06-16

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

75 participants

Primary outcome timeframe

From first dose of study drug until 4 weeks following last dose of study drug (up to 28 weeks)

Results posted on

2026-06-16

Participant Flow

The screening/baseline period was up to 12 weeks, which included at least 28 days of eDiary collection of migraine days and headache days at the end of the screening/baseline period.

The Safety population included all participants with at least 1 dose of atogepant study drug (N=75).

Participant milestones

Participant milestones
Measure	All Participants Participants received concomitant atogepant 60 mg QD from Day 1 to Week 24, along with their stable BOTOX (155 to 200 units, targeting approximately 50% of participants receiving 155 units). BOTOX was administered on Visits 2, 5, and 8. Final visit of treatment period was Week 24. Post-atogepant treatment follow-up occurred at Week 28 (or 4 weeks post-atogepant treatment for premature discontinuation).
Overall Study STARTED	75
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants Participants received concomitant atogepant 60 mg QD from Day 1 to Week 24, along with their stable BOTOX (155 to 200 units, targeting approximately 50% of participants receiving 155 units). BOTOX was administered on Visits 2, 5, and 8. Final visit of treatment period was Week 24. Post-atogepant treatment follow-up occurred at Week 28 (or 4 weeks post-atogepant treatment for premature discontinuation).
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	11
Overall Study Other	4

Baseline Characteristics

Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=75 Participants Participants received concomitant atogepant 60 mg QD from Day 1 to Week 24, along with their stable BOTOX (155 to 200 units, targeting approximately 50% of participants receiving 155 units). BOTOX was administered on Visits 2, 5, and 8. Final visit of treatment period was Week 24. Post-atogepant treatment follow-up occurred at Week 28 (or 4 weeks post-atogepant treatment for premature discontinuation).
Age, Continuous	47.7 years STANDARD_DEVIATION 13.68 • n=20 Participants
Sex: Female, Male Female	67 Participants n=20 Participants
Sex: Female, Male Male	8 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	69 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	1 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	1 Participants n=20 Participants
Race (NIH/OMB) White	73 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants

PRIMARY outcome

Timeframe: From first dose of study drug until 4 weeks following last dose of study drug (up to 28 weeks)

Population: Safety Population.

Outcome measures

Outcome measures
Measure	All Participants n=75 Participants Participants received concomitant atogepant 60 mg QD from Day 1 to Week 24, along with their stable BOTOX (155 to 200 units, targeting approximately 50% of participants receiving 155 units). BOTOX was administered on Visits 2, 5, and 8. Final visit of treatment period was Week 24. Post-atogepant treatment follow-up occurred at Week 28 (or 4 weeks post-atogepant treatment for premature discontinuation).
Number of Participants With Adverse Events (AEs) Any Treatment-emergent Adverse Event (TEAE)	49 Participants
Number of Participants With Adverse Events (AEs) AE with reasonable possibility of being related to atogepant	22 Participants
Number of Participants With Adverse Events (AEs) AE with reasonable possibility of being related to BOTOX	1 Participants
Number of Participants With Adverse Events (AEs) Any severe TEAE	2 Participants
Number of Participants With Adverse Events (AEs) Any Treatment-emergent Serious Adverse Event (TESAE)	2 Participants
Number of Participants With Adverse Events (AEs) AE leading to withdrawal of atogepant study treatment	7 Participants
Number of Participants With Adverse Events (AEs) AE leading to withdrawal of BOTOX treatment	2 Participants
Number of Participants With Adverse Events (AEs) Any TEAE leading to death	0 Participants

PRIMARY outcome

Timeframe: From first dose of study drug until last dose of study drug (24 weeks)

Population: Safety population: Number analyzed are participants with data available for analyses of the specific category.

Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. The percentage of participants with PCS laboratory values are summarized for hematology, chemistry, and urinalysis. Glomerular Filtration Rate (GFR) is a clinical measurement that calculates how many milliliters of blood the kidneys filter every second. Glucose, Urinalysis: At least 1+ indicates that the urine contains an increased concentration of sugar. Protein, Urinalysis: At least 1+ indicates that the urine contains an increased concentration of protein.

Outcome measures

Outcome measures
Measure	All Participants n=75 Participants Participants received concomitant atogepant 60 mg QD from Day 1 to Week 24, along with their stable BOTOX (155 to 200 units, targeting approximately 50% of participants receiving 155 units). BOTOX was administered on Visits 2, 5, and 8. Final visit of treatment period was Week 24. Post-atogepant treatment follow-up occurred at Week 28 (or 4 weeks post-atogepant treatment for premature discontinuation).
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Basophils (10^9/L): > 2.0 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Eosinophils (10^9/L): > 2.0 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Erythrocytes, Hematology (10^12/L): < 0.9 x Lower Limit of Normal (LLN)	1 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Erythrocytes, Hematology (10^12/L): > 1.1 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Hematocrit (RATIO): < 0.9 x Lower Limit of Normal (LLN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Hematocrit (RATIO): > 1.1 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Hemoglobin (g/L): < 0.9 x Lower Limit of Normal (LLN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Hemoglobin (g/L): > 1.1 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Leukocytes, Hematology (10^9/L): < 0.9 x Lower Limit of Normal (LLN)	1 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Leukocytes, Hematology (10^9/L): > 1.5 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Lymphocytes (10^9/L): < 0.7 x Lower Limit of Normal (LLN)	2 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Lymphocytes (10^9/L): > 1.3 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Monocytes (10^9/L): < 0.5 x Lower Limit of Normal (LLN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Monocytes (10^9/L): > 2.0 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Neutrophils (10^9/L): < 0.7 x Lower Limit of Normal (LLN)	1 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Neutrophils (10^9/L): > 1.3 x Upper Limit of Normal (ULN)	2 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Platelets (10^9/L): < 0.5 x Lower Limit of Normal (LLN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Platelets (10^9/L): > 1.5 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Alanine Aminotransferase (U/L): ≥ 3.0 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Albumin (g/L): < 0.8 x Lower Limit of Normal (LLN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Albumin (g/L): > 1.2 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Alkaline Phosphatase (U/L): ≥ 3.0 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Aspartate Aminotransferase (U/L): ≥ 3.0 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Bicarbonate (mmol/L): < 0.9 x Lower Limit of Normal (LLN)	3 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Bicarbonate (mmol/L): > 1.1 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Bilirubin, Chemistry (umol/L): ≥ 1.5 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Calcium (mmol/L): < 0.9 x Lower Limit of Normal (LLN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Calcium (mmol/L): > 1.1 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Chloride (mmol/L): < 0.9 x Lower Limit of Normal (LLN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Chloride (mmol/L): > 1.1 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Cholesterol (mmol/L): > 1.6 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Creatine Kinase (U/L): > 2.0 x Upper Limit of Normal (ULN)	4 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Creatinine (umol/L): > 1.5 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Glomerular Filtration Rate, Estimated (mL/sec/1.73m^2): < 1 mL/sec/1.73m^2	4 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Glucose, Chemistry (mmol/L): < 0.8 x Lower Limit of Normal (LLN)	3 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Glucose, Chemistry (mmol/L): > 2.0 x Upper Limit of Normal (ULN)	1 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Lactate Dehydrogenase (U/L): > 3.0 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Phosphate (mmol/L): < 0.9 x Lower Limit of Normal (LLN)	1 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Phosphate (mmol/L): > 1.1 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Potassium (mmol/L): < 0.9 x Lower Limit of Normal (LLN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Potassium (mmol/L): > 1.1 x Upper Limit of Normal (ULN)	1 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Protein, Chemistry (g/L): < 0.9 x Lower Limit of Normal (LLN)	1 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Protein, Chemistry (g/L): > 1.1 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Sodium (mmol/L): < 0.9 x Lower Limit of Normal (LLN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Sodium (mmol/L): > 1.1 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Urate (umol/L): > 1.2 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Urea Nitrogen (mmol/L): > 1.5 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Glucose, Urinalysis: At least 1+	2 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Protein, Urinalysis: At least 1+	16 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator Specific Gravity: > 1.1 x Upper Limit of Normal (ULN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator pH: < 0.9 x Lower Limit of Normal (LLN)	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator pH: > 1.1 x Upper Limit of Normal (ULN)	0 number of participants

PRIMARY outcome

Timeframe: From first dose of study drug until last dose of study drug (24 weeks)

Population: Safety Population. The number of participants with non-PCS baseline value and at least one post-baseline assessment are included in the analysis.

Potentially Clinically Significant post-Baseline vital sign values are summarized for categories: systolic and diastolic blood pressures \[sitting\], pulse rate \[sitting\], and weight. Number of participants with non-PCS baseline values who met the PCS criterion at least once post-baseline are reported.

Outcome measures

Outcome measures
Measure	All Participants n=75 Participants Participants received concomitant atogepant 60 mg QD from Day 1 to Week 24, along with their stable BOTOX (155 to 200 units, targeting approximately 50% of participants receiving 155 units). BOTOX was administered on Visits 2, 5, and 8. Final visit of treatment period was Week 24. Post-atogepant treatment follow-up occurred at Week 28 (or 4 weeks post-atogepant treatment for premature discontinuation).
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Sitting Pulse Rate (bpm): ≥ 120 and increase from Baseline of ≥ 15	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Sitting Pulse Rate (bpm): ≤ 50 and decrease from baseline of ≥ 15	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Weight (kg): Increase from Baseline of ≥ 7%	6 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Sitting Systolic Blood Pressure (mmHg): ≥ 180 and increase from Baseline of ≥ 20	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Sitting Systolic Blood Pressure (mmHg): ≤ 90 and decrease from Baseline of ≥ 20	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Sitting Diastolic Blood Pressure (mmHg): ≥ 105 and increase from Baseline of ≥ 15	1 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Sitting Diastolic Blood Pressure (mmHg): ≤ 50 and decrease from Baseline of ≥ 15	1 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Weight (kg): Decrease from Baseline of ≥ 7%	6 number of participants

PRIMARY outcome

Timeframe: From first dose of study drug until last dose of study drug (24 weeks)

Population: Safety Population. Two participants were not assessed and were not included in this analysis. Participants are only counted once for each suicidal ideation and each suicidal behavior. Only the most severe suicidal ideation and the most severe suicidal behavior across all visits during the specific period are counted for each participant.

The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is 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).

Outcome measures

Outcome measures
Measure	All Participants n=73 Participants Participants received concomitant atogepant 60 mg QD from Day 1 to Week 24, along with their stable BOTOX (155 to 200 units, targeting approximately 50% of participants receiving 155 units). BOTOX was administered on Visits 2, 5, and 8. Final visit of treatment period was Week 24. Post-atogepant treatment follow-up occurred at Week 28 (or 4 weeks post-atogepant treatment for premature discontinuation).
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period No suicidal ideation	73 number of participants
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period Suicidal ideation	0 number of participants
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period Most severe suicidal ideation: Active suicidal ideation with specific plan and intent	0 number of participants
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period Most severe suicidal ideation: Active suicidal ideation with some intent to act, w/out specific plan	0 number of participants
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period Most severe suicidal ideation: Active suicidal ideation w/ any method (not plan) w/out intent to act	0 number of participants
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period Most severe suicidal ideation: Non-specific active suicidal thoughts	0 number of participants
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period Most severe suicidal ideation: Wish to be dead	0 number of participants
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period No suicidal behavior	73 number of participants
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period Suicidal behavior	0 number of participants
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period Most severe suicidal behavior: Actual attempt	0 number of participants
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period Most severe suicidal behavior: Interrupted attempt	0 number of participants
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period Most severe suicidal behavior: Aborted attempt	0 number of participants
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period Most severe suicidal behavior: Preparatory acts or behavior	0 number of participants
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period Completed Suicide	0 number of participants
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period Non-suicidal self-injurious behavior	1 number of participants

PRIMARY outcome

Timeframe: From first dose of study drug until last dose of study drug (24 weeks)

Population: Safety Population. Participants with non-PCS baseline value and at least one post-baseline assessment are included.

12-lead ECGs were performed at select study visits.

Outcome measures

Outcome measures
Measure	All Participants n=75 Participants Participants received concomitant atogepant 60 mg QD from Day 1 to Week 24, along with their stable BOTOX (155 to 200 units, targeting approximately 50% of participants receiving 155 units). BOTOX was administered on Visits 2, 5, and 8. Final visit of treatment period was Week 24. Post-atogepant treatment follow-up occurred at Week 28 (or 4 weeks post-atogepant treatment for premature discontinuation).
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator PR Interval (msec): ≥ 250	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator QRS Interval (msec): ≥ 150	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator QTcF Interval (msec): > 500	0 number of participants
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator QTcF Interval (msec): Increase from Baseline of > 60	0 number of participants

Adverse Events

All Participants

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=75 participants at risk Participants received concomitant atogepant 60 mg QD from Day 1 to Week 24, along with their stable BOTOX (155 to 200 units, targeting approximately 50% of participants receiving 155 units). BOTOX was administered on Visits 2, 5, and 8. Final visit of treatment period was Week 24. Post-atogepant treatment follow-up occurred at Week 28 (or 4 weeks post-atogepant treatment for premature discontinuation).
Gastrointestinal disorders HAEMATEMESIS	1.3% 1/75 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time on follow-up was 225 days.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	1.3% 1/75 • Number of events 1 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time on follow-up was 225 days.

Other adverse events

Other adverse events
Measure	All Participants n=75 participants at risk Participants received concomitant atogepant 60 mg QD from Day 1 to Week 24, along with their stable BOTOX (155 to 200 units, targeting approximately 50% of participants receiving 155 units). BOTOX was administered on Visits 2, 5, and 8. Final visit of treatment period was Week 24. Post-atogepant treatment follow-up occurred at Week 28 (or 4 weeks post-atogepant treatment for premature discontinuation).
Gastrointestinal disorders CONSTIPATION	16.0% 12/75 • Number of events 12 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time on follow-up was 225 days.
Gastrointestinal disorders NAUSEA	13.3% 10/75 • Number of events 11 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time on follow-up was 225 days.
Infections and infestations COVID-19	5.3% 4/75 • Number of events 4 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time on follow-up was 225 days.
Infections and infestations URINARY TRACT INFECTION	8.0% 6/75 • Number of events 6 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time on follow-up was 225 days.
Metabolism and nutrition disorders DECREASED APPETITE	6.7% 5/75 • Number of events 5 • All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time on follow-up was 225 days.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER