Trial Outcomes & Findings for Safety and Tolerability Study of Drug to Treat Schizophrenia (NCT NCT00044005)
NCT ID: NCT00044005
Last Updated: 2014-04-17
Results Overview
The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
6-months
Results posted on
2014-04-17
Participant Flow
Participant milestones
| Measure |
Lurasidone 20 mg
Lurasdione 20 mg oral tablets
|
Lurasidone 40 mg
Lurasidone 40 mg oral tablets
|
Lurasidone 80mg
Lurasidone 80mg oral tablets
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
33
|
|
Overall Study
COMPLETED
|
13
|
19
|
11
|
|
Overall Study
NOT COMPLETED
|
19
|
14
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability Study of Drug to Treat Schizophrenia
Baseline characteristics by cohort
| Measure |
Lurasidone 20 mg
n=32 Participants
Lurasdione 20 mg oral tablets
|
Lurasidone 40 mg
n=33 Participants
Lurasidone 40 mg oral tablets
|
Lurasidone 80mg
n=33 Participants
Lurasidone 80mg oral tablets
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.8 years
STANDARD_DEVIATION 7.8 • n=39 Participants
|
42.2 years
STANDARD_DEVIATION 12.4 • n=41 Participants
|
40.8 years
STANDARD_DEVIATION 10.7 • n=35 Participants
|
41.3 years
STANDARD_DEVIATION 10.4 • n=31 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
28 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
70 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=39 Participants
|
33 participants
n=41 Participants
|
33 participants
n=35 Participants
|
98 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 6-monthsPopulation: No formal hypothesis testing was performed. However,descriptive statistics were provided and data summarized. Safety analyses were conducted on the safety population, that included all subjects who had received at least 1 dose of open-label study medication.
The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.
Outcome measures
| Measure |
Lurasidone 20 mg
n=32 Participants
Lurasdione 20 mg oral tablets
|
Lurasidone 40 mg
n=33 Participants
Lurasidone 40 mg oral tablets
|
Lurasidone 80mg
n=33 Participants
Lurasidone 80mg oral tablets
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
19 participants
7.8
|
22 participants
12.4
|
18 participants
10.7
|
Adverse Events
Lurasidone 20 mg
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Lurasidone 40 mg
Serious events: 6 serious events
Other events: 22 other events
Deaths: 0 deaths
Lurasidone 80mg
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lurasidone 20 mg
n=32 participants at risk
Lurasdione 20 mg oral tablets
|
Lurasidone 40 mg
n=33 participants at risk
Lurasidone 40 mg oral tablets
|
Lurasidone 80mg
n=33 participants at risk
Lurasidone 80mg oral tablets
|
|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
9.4%
3/32 • Number of events 3
|
100.0%
6/6 • Number of events 6
|
100.0%
3/3 • Number of events 3
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/32
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/32
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/32
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/32
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Psychiatric disorders
Schizophrenia
|
6.2%
2/32 • Number of events 2
|
12.1%
4/33 • Number of events 4
|
3.0%
1/33 • Number of events 1
|
|
Psychiatric disorders
Suicidal Behavior
|
0.00%
0/32
|
3.0%
1/33 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Psychiatric disorders
Suicidal Ideation
|
3.1%
1/32 • Number of events 1
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Surgical and medical procedures
Endotracheal Intubation
|
0.00%
0/32
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
Other adverse events
| Measure |
Lurasidone 20 mg
n=32 participants at risk
Lurasdione 20 mg oral tablets
|
Lurasidone 40 mg
n=33 participants at risk
Lurasidone 40 mg oral tablets
|
Lurasidone 80mg
n=33 participants at risk
Lurasidone 80mg oral tablets
|
|---|---|---|---|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/32
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
|
Eye disorders
Eye Pain
|
0.00%
0/32
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/32
|
6.1%
2/33 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
2/32 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/32
|
0.00%
0/33
|
6.1%
2/33 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
2/32 • Number of events 2
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Number of events 1
|
9.1%
3/33 • Number of events 3
|
6.1%
2/33 • Number of events 2
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
3.1%
1/32 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
|
Gastrointestinal disorders
Toothache
|
3.1%
1/32 • Number of events 1
|
9.1%
3/33 • Number of events 3
|
6.1%
2/33 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
3/32 • Number of events 3
|
6.1%
2/33 • Number of events 2
|
9.1%
3/33 • Number of events 3
|
|
General disorders
Fatigue
|
3.1%
1/32 • Number of events 1
|
0.00%
0/33
|
6.1%
2/33 • Number of events 2
|
|
General disorders
Oedema Peripheral
|
0.00%
0/32
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/32
|
0.00%
0/33
|
6.1%
2/33 • Number of events 2
|
|
Infections and infestations
Influenza
|
3.1%
1/32 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
|
Infections and infestations
Nasopharyngitis
|
9.4%
3/32 • Number of events 3
|
12.1%
4/33 • Number of events 4
|
0.00%
0/33
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.4%
3/32 • Number of events 3
|
3.0%
1/33 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Urinary Tract Infection
|
3.1%
1/32 • Number of events 1
|
9.1%
3/33 • Number of events 3
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
2/32 • Number of events 2
|
0.00%
0/33
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
6.2%
2/32 • Number of events 2
|
0.00%
0/33
|
0.00%
0/33
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
6.2%
2/32 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/32
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
|
Investigations
Weight Decreased
|
3.1%
1/32 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
|
Investigations
Weight Increased
|
3.1%
1/32 • Number of events 1
|
0.00%
0/33
|
6.1%
2/33 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/32
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
3.1%
1/32 • Number of events 1
|
0.00%
0/33
|
6.1%
2/33 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/32
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
|
Nervous system disorders
Akathisia
|
6.2%
2/32 • Number of events 2
|
6.1%
2/33 • Number of events 2
|
6.1%
2/33 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
6.2%
2/32 • Number of events 2
|
18.2%
6/33 • Number of events 6
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/32
|
3.0%
1/33 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
|
Nervous system disorders
Headache
|
15.6%
5/32 • Number of events 5
|
15.2%
5/33 • Number of events 5
|
15.2%
5/33 • Number of events 5
|
|
Nervous system disorders
Sedation
|
0.00%
0/32
|
12.1%
4/33 • Number of events 4
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
6.2%
2/32 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
3.1%
1/32 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/32
|
9.1%
3/33 • Number of events 3
|
3.0%
1/33 • Number of events 1
|
|
Psychiatric disorders
Depressed Mood
|
6.2%
2/32 • Number of events 2
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
9.4%
3/32 • Number of events 3
|
3.0%
1/33 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
|
Psychiatric disorders
Suicidal Ideation
|
6.2%
2/32 • Number of events 2
|
0.00%
0/33
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
2/32 • Number of events 2
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/32
|
3.0%
1/33 • Number of events 1
|
9.1%
3/33 • Number of events 3
|
|
Psychiatric disorders
Depression
|
3.1%
1/32 • Number of events 1
|
0.00%
0/33
|
12.1%
4/33 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place