Trial Outcomes & Findings for Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine (NCT NCT03700320)

Last Updated: 2021-06-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

744 participants

Primary outcome timeframe

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

Results posted on

2021-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Atogepant 60 mg Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
Overall Study STARTED	198	546
Overall Study Safety Population; Received Treatment	196	543
Overall Study Entered Safety Follow-up	159	472
Overall Study COMPLETED	136	373
Overall Study NOT COMPLETED	62	173

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Atogepant 60 mg Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
Overall Study Adverse Event	5	31
Overall Study Lack of Efficacy	2	5
Overall Study Withdrawal by Subject	29	75
Overall Study Lost to Follow-up	16	23
Overall Study Pregnancy	2	4
Overall Study Protocol Deviation	7	31
Overall Study Non-compliance with Study Drug	1	3
Overall Study Reason not Specified	0	1

Baseline Characteristics

Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral SOC Migraine Preventive Medication n=196 Participants 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.	Atogepant 60 mg n=543 Participants Atogepant 60 mg tablet taken orally, once daily for 52 weeks.	Total n=739 Participants Total of all reporting groups
Age, Continuous	41.1 years STANDARD_DEVIATION 12.09 • n=93 Participants	42.5 years STANDARD_DEVIATION 12.03 • n=4 Participants	42.2 years STANDARD_DEVIATION 12.05 • n=27 Participants
Sex: Female, Male Female	172 Participants n=93 Participants	479 Participants n=4 Participants	651 Participants n=27 Participants
Sex: Female, Male Male	24 Participants n=93 Participants	64 Participants n=4 Participants	88 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=93 Participants	83 Participants n=4 Participants	112 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	166 Participants n=93 Participants	460 Participants n=4 Participants	626 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Asian	5 Participants n=93 Participants	12 Participants n=4 Participants	17 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Black or African American	38 Participants n=93 Participants	100 Participants n=4 Participants	138 Participants n=27 Participants
Race (NIH/OMB) White	145 Participants n=93 Participants	416 Participants n=4 Participants	561 Participants n=27 Participants
Race (NIH/OMB) More than one race	5 Participants n=93 Participants	10 Participants n=4 Participants	15 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Oral SOC Migraine Preventive Medication n=196 Participants 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.	Atogepant 60 mg n=543 Participants Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)	78.6 percentage of participants	67.0 percentage of participants

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Oral SOC Migraine Preventive Medication n=196 Participants 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.	Atogepant 60 mg n=543 Participants Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Urine Glucose At Least 1+	4.3 percentage of participants	3.0 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Eosinophils Absolute Cell Count (10^9/liter (L)): >2.0 × upper limit of normal (ULN)	0.0 percentage of participants	0.6 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Hematocrit (RATIO): <0.9 × lower limit of normal (LLN)	1.6 percentage of participants	1.7 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Hematocrit (RATIO): >1.1 × ULN	0.0 percentage of participants	0.2 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Hemoglobin (gram (g)/L): <0.9 × LLN	3.3 percentage of participants	3.1 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Lymphocytes Absolute Cell Count (10^9/L): <0.7 × LLN	0.5 percentage of participants	0.8 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Lymphocytes Absolute Cell Count (10^9/L): >1.3 × ULN	0.5 percentage of participants	0.2 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Monocytes Absolute Cell Count (10^9/L): <0.5 × LLN	1.1 percentage of participants	0.2 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Neutrophils Absolute Cell Count (10^9/L): <0.7 × LLN	2.1 percentage of participants	2.3 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Neutrophils Absolute Cell Count (10^9/L): >1.3 × ULN	4.8 percentage of participants	7.1 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Platelet Count (Thrombocytes) (10^9/L): >1.5 × ULN	0.5 percentage of participants	0.2 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Red Blood Cell Count (10^12/L): <0.9 × LLN	3.2 percentage of participants	2.1 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator White Blood Cell Count (10^9/L): <0.9 × LLN	3.2 percentage of participants	4.6 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator White Blood Cell Count (10^9/L): >1.5 × ULN	1.1 percentage of participants	0.6 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Alanine Aminotransferase (serum glutamic-pyruvic transaminase (SGPT)) (Unit (U)/L): ≥3.0 × ULN	1.6 percentage of participants	1.9 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Aspartate Aminotransferase (serum glutamic-oxaloacetic transaminase (SGOT)) (U/L): ≥3.0 × ULN	2.1 percentage of participants	1.5 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Bicarbonate (HCO3) (millimole (mmol)/L): <0.9 × LLN	1.6 percentage of participants	0.8 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Bilirubin, Total (micromole (umol)/L): ≥1.5 × ULN	0.0 percentage of participants	0.8 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Blood Urea Nitrogen (mmol/L): >1.5 × ULN	0.5 percentage of participants	0.4 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Creatine Kinase (U/L): >2.0 × ULN	14.1 percentage of participants	9.1 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Creatinine (umol/L): >1.5 × ULN	1.1 percentage of participants	0.4 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Glomerular Filtration Rate(GFR) Estimated Calculation:<60 milliliter(mL)/minute(min)/1.73 meter(m)^2	15.2 percentage of participants	15.9 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Glucose, Non-fasting (mmol/L): <0.8 × LLN	5.3 percentage of participants	4.2 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Glucose, Non-fasting (mmol/L): >2.0 × ULN	2.1 percentage of participants	0.8 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Lactate Dehydrogenase (U/L): >3.0 × ULN	0.0 percentage of participants	0.4 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Phosphorus (mmol/L): <0.9 × LLN	2.1 percentage of participants	2.6 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Phosphorus (mmol/L): >1.1 × ULN	0.0 percentage of participants	0.2 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Potassium (mmol/L): <0.9 × LLN	1.1 percentage of participants	0.8 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Potassium (mmol/L): >1.1 × ULN	4.3 percentage of participants	5.1 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Protein, Total (g/L): <0.9 × LLN	3.2 percentage of participants	1.5 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Uric Acid (Urate) (umol/L): >1.2 × ULN	1.6 percentage of participants	1.1 percentage of participants
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator Urine Protein: At Least 1+	26.2 percentage of participants	27.4 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 52

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.

Outcome measures

Outcome measures
Measure	Oral SOC Migraine Preventive Medication n=196 Participants 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.	Atogepant 60 mg n=543 Participants Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator PR Interval, Single Beat millisecond (msec): ≥250	0.0 percentage of participants	0.2 percentage of participants
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator QTcB Interval, Single Beat (msec): Increase >60 from Baseline (BL)	0.6 percentage of participants	0.4 percentage of participants
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator QTcF Interval, Single Beat (msec): Increase >60 from BL	0.6 percentage of participants	0.0 percentage of participants

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Oral SOC Migraine Preventive Medication n=196 Participants 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.	Atogepant 60 mg n=543 Participants Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator Systolic Blood Pressure (SBP) Sitting (millimeter of mercury(mmHg)):≤90 and Decrease of ≥20 from BL	3.7 percentage of participants	2.6 percentage of participants
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator SBP Sitting (mmHg): ≥180 and Increase of ≥20 from BL	0.0 percentage of participants	0.4 percentage of participants
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator SBP Standing (mmHg): ≤90 and Decrease of ≥20 from BL	5.8 percentage of participants	3.4 percentage of participants
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator SBP Standing (mmHg): ≥180 and Increase of ≥20 from BL	0.0 percentage of participants	0.6 percentage of participants
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator Standing - Sitting SBP (mmHg): ≤-20	13.8 percentage of participants	11.4 percentage of participants
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator Diastolic Blood Pressure (DBP) Sitting (mmHg): ≤50 and Decrease of ≥15 from BL	3.2 percentage of participants	0.6 percentage of participants
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator DBP Sitting (mmHg): ≥105 and Increase of ≥15 from BL	1.1 percentage of participants	2.3 percentage of participants
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator DBP Standing (mmHg): ≤50 and Decrease of ≥15 from BL	1.1 percentage of participants	0.9 percentage of participants
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator DBP Standing (mmHg): ≥105 and Increase of ≥15 from BL	5.8 percentage of participants	4.0 percentage of participants
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator Standing - Sitting DBP (mmHg): ≤-15	10.1 percentage of participants	8.7 percentage of participants
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator Pulse Rate (PR) Sitting (beats/min): ≤50 and Decrease of ≥15 from BL	1.6 percentage of participants	1.1 percentage of participants
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator PR Standing (beats/min): ≤50 and Decrease of ≥15 from BL	0.0 percentage of participants	0.2 percentage of participants
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator PR Standing (beats/min): ≥120 and Increase of ≥15 from BL	2.6 percentage of participants	1.3 percentage of participants
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator Standing - Sitting PR (beats/min): ≥25	6.3 percentage of participants	10.0 percentage of participants
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator Weight (kg): Decrease of ≥7% from BL	14.7 percentage of participants	24.1 percentage of participants
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator Weight (kg): Increase of ≥7% from BL	12.6 percentage of participants	7.3 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 52

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

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.

Outcome measures

Outcome measures
Measure	Oral SOC Migraine Preventive Medication n=196 Participants 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.	Atogepant 60 mg n=543 Participants Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior Suicidal Ideation (SI): Wish to be Dead	4 Participants	0 Participants
Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior SI: Non-Specific Active Suicidal Thoughts	1 Participants	2 Participants
Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior SI: Active SI with Some Intent to Act, Without Specific Plan	0 Participants	1 Participants
Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior SI: Active SI With Specific Plan and Intent	0 Participants	2 Participants
Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior Suicidal Behavior (SB): Actual Attempt	0 Participants	2 Participants

Adverse Events

Oral SOC Migraine Preventive Medication

Serious events: 7 serious events

Other events: 91 other events

Deaths: 0 deaths

Atogepant 60 mg

Serious events: 24 serious events

Other events: 197 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Oral SOC Migraine Preventive Medication n=196 participants at risk 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.	Atogepant 60 mg n=543 participants at risk Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
Gastrointestinal disorders Constipation	3.1% 6/196 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.	7.2% 39/543 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.
Gastrointestinal disorders Nausea	6.1% 12/196 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.	6.3% 34/543 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.
General disorders Fatigue	6.1% 12/196 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.	2.6% 14/543 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.
Infections and infestations Upper respiratory tract infection	12.2% 24/196 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.	10.3% 56/543 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.
Infections and infestations Urinary tract infection	4.6% 9/196 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.	5.2% 28/543 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.
Infections and infestations Nasopharyngitis	5.1% 10/196 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.	4.4% 24/543 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.
Investigations Weight increased	5.6% 11/196 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.	1.3% 7/543 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.
Nervous system disorders Dizziness	11.2% 22/196 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.	3.1% 17/543 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.
Nervous system disorders Paraesthesia	6.1% 12/196 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.	1.5% 8/543 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.
Psychiatric disorders Anxiety	5.6% 11/196 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.	2.8% 15/543 • From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) All-cause Mortality: Intent-to-treat (ITT) Population included all randomized participants. Adverse Events: Safety Population included all participants who received ≥1 dose of study intervention.

Additional Information

Therapeutic Area Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER