Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression (NCT NCT01396447)

Last Updated: 2018-05-01

Results Overview

The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The scores on the 10 items are summed for a total score that can range from 0 to 60. A higher score indicates greater depression. A negative change score indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

584 participants

Primary outcome timeframe

Baseline to Week 6

Results posted on

2018-05-01

Participant Flow

Adult participants with a diagnosis of bipolar I disorder with a current major depressive episode were considered for participation in the study.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo orally once a day for 8 weeks.	Cariprazine 0.75 mg Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.	Cariprazine 1.5 mg Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.	Cariprazine 3.0 mg Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
Overall Study STARTED	148	143	147	146
Overall Study Received Treatment	145	141	146	146
Overall Study COMPLETED	105	103	117	94
Overall Study NOT COMPLETED	43	40	30	52

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo orally once a day for 8 weeks.	Cariprazine 0.75 mg Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.	Cariprazine 1.5 mg Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.	Cariprazine 3.0 mg Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
Overall Study Did Not Receive Treatment	3	2	1	0
Overall Study Adverse Event	15	12	12	17
Overall Study Insufficient Therapeutic Response	5	5	2	4
Overall Study Protocol Violation	5	2	3	7
Overall Study Withdrawal of Consent	11	9	4	15
Overall Study Lost to Follow-up	4	8	7	9
Overall Study Other Miscellaneous Reasons	0	2	1	0

Baseline Characteristics

Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=145 Participants Participants received placebo orally once a day for 8 weeks.	Cariprazine 0.75 mg n=141 Participants Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.	Cariprazine 1.5 mg n=146 Participants Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.	Cariprazine 3.0 mg n=146 Participants Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.	Total n=578 Participants Total of all reporting groups
Age, Continuous	43.6 years STANDARD_DEVIATION 12.0 • n=5 Participants	40.1 years STANDARD_DEVIATION 11.2 • n=7 Participants	40.9 years STANDARD_DEVIATION 11.4 • n=5 Participants	42.8 years STANDARD_DEVIATION 10.8 • n=4 Participants	41.9 years STANDARD_DEVIATION 11.4 • n=21 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	91 Participants n=7 Participants	92 Participants n=5 Participants	88 Participants n=4 Participants	360 Participants n=21 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	50 Participants n=7 Participants	54 Participants n=5 Participants	58 Participants n=4 Participants	218 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	48 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	133 Participants n=5 Participants	128 Participants n=7 Participants	135 Participants n=5 Participants	134 Participants n=4 Participants	530 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized White	110 Participants n=5 Participants	111 Participants n=7 Participants	109 Participants n=5 Participants	113 Participants n=4 Participants	443 Participants n=21 Participants
Race/Ethnicity, Customized Black or African-American	30 Participants n=5 Participants	26 Participants n=7 Participants	30 Participants n=5 Participants	26 Participants n=4 Participants	112 Participants n=21 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants
Weight	79.98 kg STANDARD_DEVIATION 17.08 • n=5 Participants	80.81 kg STANDARD_DEVIATION 18.36 • n=7 Participants	81.43 kg STANDARD_DEVIATION 16.79 • n=5 Participants	81.45 kg STANDARD_DEVIATION 17.86 • n=4 Participants	80.92 kg STANDARD_DEVIATION 17.49 • n=21 Participants
Body Mass Index (BMI)	27.81 kg/m^2 STANDARD_DEVIATION 5.27 • n=5 Participants	28.42 kg/m^2 STANDARD_DEVIATION 5.71 • n=7 Participants	28.44 kg/m^2 STANDARD_DEVIATION 5.39 • n=5 Participants	28.28 kg/m^2 STANDARD_DEVIATION 5.64 • n=4 Participants	28.24 kg/m^2 STANDARD_DEVIATION 5.50 • n=21 Participants
Waist circumference	91.40 cm STANDARD_DEVIATION 14.24 • n=5 Participants	93.32 cm STANDARD_DEVIATION 15.45 • n=7 Participants	93.38 cm STANDARD_DEVIATION 14.55 • n=5 Participants	93.24 cm STANDARD_DEVIATION 15.40 • n=4 Participants	92.83 cm STANDARD_DEVIATION 14.90 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline to Week 6

Population: Intent-to-treat population: All randomized participants who took at least 1 dose of investigational product and had at least 1 post-Baseline assessment of the Montgomery-Åsberg Depression Rating Scale.

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Participants received placebo orally once a day for 8 weeks.	Cariprazine 0.75 mg n=140 Participants Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.	Cariprazine 1.5 mg n=145 Participants Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.	Cariprazine 3.0 mg n=145 Participants Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6	-11.1 units on a scale Standard Error 0.9	-13.0 units on a scale Standard Error 0.9	-15.1 units on a scale Standard Error 0.8	-13.7 units on a scale Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline to Week 6

The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=141 Participants Participants received placebo orally once a day for 8 weeks.	Cariprazine 0.75 mg n=140 Participants Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.	Cariprazine 1.5 mg n=145 Participants Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.	Cariprazine 3.0 mg n=145 Participants Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6	-1.0 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1	-1.4 units on a scale Standard Error 0.1	-1.3 units on a scale Standard Error 0.1

Adverse Events

Placebo

Serious events: 5 serious events

Other events: 42 other events

Deaths: 0 deaths

Cariprazine 0.75 mg

Serious events: 1 serious events

Other events: 43 other events

Deaths: 0 deaths

Cariprazine 1.5 mg

Serious events: 2 serious events

Other events: 51 other events

Deaths: 0 deaths

Cariprazine 3.0 mg

Serious events: 2 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=145 participants at risk Participants received placebo orally once a day for 8 weeks.	Cariprazine 0.75 mg n=141 participants at risk Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.	Cariprazine 1.5 mg n=146 participants at risk Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.	Cariprazine 3.0 mg n=146 participants at risk Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
Injury, poisoning and procedural complications Fall	0.00% 0/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.68% 1/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.68% 1/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.68% 1/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.
Injury, poisoning and procedural complications Injury	0.00% 0/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.68% 1/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.
Nervous system disorders Vertigo CNS origin	0.00% 0/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.68% 1/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.
Nervous system disorders Hemiparesis	0.69% 1/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.
Psychiatric disorders Depression	0.69% 1/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.71% 1/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.
Psychiatric disorders Hypomania	0.00% 0/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.68% 1/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.
Psychiatric disorders Mania	0.69% 1/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.
Psychiatric disorders Suicidal ideation	0.69% 1/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.69% 1/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	0.00% 0/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.

Other adverse events

Other adverse events
Measure	Placebo n=145 participants at risk Participants received placebo orally once a day for 8 weeks.	Cariprazine 0.75 mg n=141 participants at risk Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.	Cariprazine 1.5 mg n=146 participants at risk Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.	Cariprazine 3.0 mg n=146 participants at risk Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
Gastrointestinal disorders Nausea	4.8% 7/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	8.5% 12/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	8.2% 12/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	8.2% 12/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.
Gastrointestinal disorders Diarrhoea	6.9% 10/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	1.4% 2/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	6.2% 9/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	2.1% 3/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.
Nervous system disorders Akathisia	1.4% 2/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	2.8% 4/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	4.8% 7/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	14.4% 21/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.
Nervous system disorders Headache	11.7% 17/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	7.8% 11/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	7.5% 11/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	6.8% 10/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.
Nervous system disorders Somnolence	4.8% 7/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	4.3% 6/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	6.8% 10/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	6.8% 10/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.
Psychiatric disorders Insomnia	8.3% 12/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	11.3% 16/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	6.8% 10/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	11.6% 17/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.
Psychiatric disorders Restlessness	3.4% 5/145 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	2.8% 4/141 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	2.7% 4/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.	6.2% 9/146 • Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment. Safety population: All randomized participants who took at least 1 dose of investigational product.

Additional Information

Therapeutic Area Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
Publication restrictions are in place

Restriction type: OTHER