Trial Outcomes & Findings for Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Participants With Tourette's Disorder (NCT NCT03661983)
NCT ID: NCT03661983
Last Updated: 2021-03-09
Results Overview
Relapse was defined as a loss of ≥ 50% of the improvement experienced during the open-label stabilization phase (i.e., improvement at the last assessment of Yale Global Tic Severity Scale (YGTSS) before randomization) on the Yale Global Tic Severity Scale Total Tic Score (YGTSS TTS). YGTSS provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
From Randomization up to 12 weeks in Double-blind Randomized Withdrawal Phase
Results posted on
2021-03-09
Participant Flow
Participants took part in the study at 13 investigative sites in Canada, the United States and Hungary from Oct 13, 2018 to Jun 30, 2020.
Pediatric participants with a diagnosis of Tourette's Disorder were enrolled in this to receive oral aripiprazole in an Open-label Stabilization Phase and a Double-blind Randomized Withdrawal Phase and then followed for safety up to 30 days post-last dose.
Participant milestones
| Measure |
Open Label Stabilization Phase: Aripiprazole
Participants began treatment with aripiprazole at a 2.0 mg/day dose, with the dose titrated to 5.0 mg/day after 2 days. Subsequent dose adjustments were based on the participant's weight to achieve optimum control of tics up to the maximum recommended doses based on the United States Labeling, up to Week 8 and then continued on the most stabilized dose up to minimum Week 14 or maximum Week 20. Participants who met stabilization criteria were randomized to Double-blind Randomization Phase.
|
Double Blind Phase: Aripiprazole Full Dose
Participants who met stabilization criteria and randomized to receive full dose of aripiprazole i.e. 5 mg or 10 mg for \<50 kg participants,and 10 mg or 20 mg for \>50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.
|
Double Blind Phase: Aripiprazole Half Dose
Participants who met stabilization criteria and randomized to receive half dose of aripiprazole i.e. 2 mg or 5 mg for \<50 kg participants, and 5 mg or 10 mg for \>50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.
|
Double Blind Phase: Placebo
Participants who met randomization criteria and randomized to receive aripiprazole matching-placebo tablets, 2 daily, orally, up to 12 weeks in Double-Blind Phase.
|
|---|---|---|---|---|
|
Open Label Stabilization Phase
STARTED
|
36
|
0
|
0
|
0
|
|
Open Label Stabilization Phase
COMPLETED
|
25
|
0
|
0
|
0
|
|
Open Label Stabilization Phase
NOT COMPLETED
|
11
|
0
|
0
|
0
|
|
Double-blind Randomized Phase
STARTED
|
0
|
9
|
8
|
8
|
|
Double-blind Randomized Phase
COMPLETED
|
0
|
7
|
7
|
0
|
|
Double-blind Randomized Phase
NOT COMPLETED
|
0
|
2
|
1
|
8
|
Reasons for withdrawal
| Measure |
Open Label Stabilization Phase: Aripiprazole
Participants began treatment with aripiprazole at a 2.0 mg/day dose, with the dose titrated to 5.0 mg/day after 2 days. Subsequent dose adjustments were based on the participant's weight to achieve optimum control of tics up to the maximum recommended doses based on the United States Labeling, up to Week 8 and then continued on the most stabilized dose up to minimum Week 14 or maximum Week 20. Participants who met stabilization criteria were randomized to Double-blind Randomization Phase.
|
Double Blind Phase: Aripiprazole Full Dose
Participants who met stabilization criteria and randomized to receive full dose of aripiprazole i.e. 5 mg or 10 mg for \<50 kg participants,and 10 mg or 20 mg for \>50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.
|
Double Blind Phase: Aripiprazole Half Dose
Participants who met stabilization criteria and randomized to receive half dose of aripiprazole i.e. 2 mg or 5 mg for \<50 kg participants, and 5 mg or 10 mg for \>50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.
|
Double Blind Phase: Placebo
Participants who met randomization criteria and randomized to receive aripiprazole matching-placebo tablets, 2 daily, orally, up to 12 weeks in Double-Blind Phase.
|
|---|---|---|---|---|
|
Open Label Stabilization Phase
Adverse Event
|
5
|
0
|
0
|
0
|
|
Open Label Stabilization Phase
Lack of Efficacy
|
1
|
0
|
0
|
0
|
|
Open Label Stabilization Phase
Withdrawal by Parent/Guardian
|
2
|
0
|
0
|
0
|
|
Open Label Stabilization Phase
Study Terminated by Sponsor
|
3
|
0
|
0
|
0
|
|
Double-blind Randomized Phase
Adverse Event
|
0
|
1
|
0
|
0
|
|
Double-blind Randomized Phase
Disease Relapse
|
0
|
0
|
0
|
6
|
|
Double-blind Randomized Phase
Withdrawal by Parent/Guardian
|
0
|
0
|
0
|
1
|
|
Double-blind Randomized Phase
Study Terminated by Sponsor
|
0
|
1
|
1
|
1
|
Baseline Characteristics
Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Participants With Tourette's Disorder
Baseline characteristics by cohort
| Measure |
Open Label Stabilization Phase: Aripiprazole
n=36 Participants
Participants began treatment with aripiprazole at a 2.0 mg/day dose, with the dose titrated to 5.0 mg/day after 2 days. Subsequent dose adjustments were based on the participant's weight to achieve optimum control of tics up to the maximum recommended doses based on the United States Labeling, up to Week 8 and then continued on the most stabilized dose up to minimum Week 14 or maximum Week 20. Participants who met stabilization criteria were randomized to Double-blind Randomization Phase.
|
|---|---|
|
Age, Continuous
|
10.9 years
STANDARD_DEVIATION 3.0 • n=39 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=39 Participants
|
|
Region of Enrollment
Hungary
|
4 participants
n=39 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: From Randomization up to 12 weeks in Double-blind Randomized Withdrawal PhasePopulation: Intent to Treat (ITT) Sample included all participants who were randomized and received at least 1 dose of randomized investigational medicinal product (IMP) were included in this dataset and were analyzed according to the treatment group they were randomized to.
Relapse was defined as a loss of ≥ 50% of the improvement experienced during the open-label stabilization phase (i.e., improvement at the last assessment of Yale Global Tic Severity Scale (YGTSS) before randomization) on the Yale Global Tic Severity Scale Total Tic Score (YGTSS TTS). YGTSS provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms.
Outcome measures
| Measure |
Double Blind Phase: Aripiprazole Full Dose
n=9 Participants
Participants who met stabilization criteria and randomized to receive full dose of aripiprazole i.e. 5 mg or 10 mg for \<50 kg participants,and 10 mg or 20 mg for \>50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.
|
Double Blind Phase: Aripiprazole Half Dose
n=8 Participants
Participants who met stabilization criteria and randomized to receive half dose of aripiprazole i.e. 2 mg or 5 mg for \<50 kg participants, and 5 mg or 10 mg for \>50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.
|
Double Blind Phase: Placebo
n=8 Participants
Participants who met randomization criteria and randomized to receive aripiprazole matching-placebo tablets, 2 daily, orally, up to 12 weeks in Double-Blind Phase.
|
|---|---|---|---|
|
Percentage of Participants With Relapse During the Double-blind Randomized Withdrawal Phase
|
0.0 percentage of participants
|
0.0 percentage of participants
|
75.0 percentage of participants
|
Adverse Events
Open Label Stabilization Phase: Aripiprazole
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Double Blind Phase: Aripiprazole Full Dose
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Double Blind Phase: Aripiprazole Half Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Double Blind Phase: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open Label Stabilization Phase: Aripiprazole
n=36 participants at risk
Participants began treatment with aripiprazole at a 2.0 mg/day dose, with the dose titrated to 5.0 mg/day after 2 days. Subsequent dose adjustments were based on the participant's weight to achieve optimum control of tics up to the maximum recommended doses based on the United States Labeling, up to Week 8 and then continued on the most stabilized dose up to minimum Week 14 or maximum Week 20. Participants who met stabilization criteria were randomized to Double-blind Randomization Phase.
|
Double Blind Phase: Aripiprazole Full Dose
n=9 participants at risk
Participants who met stabilization criteria and randomized to receive full dose of aripiprazole i.e. 5 mg or 10 mg for \<50 kg participants,and 10 mg or 20 mg for \>50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-blind Phase.
|
Double Blind Phase: Aripiprazole Half Dose
n=8 participants at risk
Participants who met stabilization criteria and randomized to receive half dose of aripiprazole i.e. 2 mg or 5 mg for \<50 kg participants, and 5 mg or 10 mg for \>50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.
|
Double Blind Phase: Placebo
n=8 participants at risk
Participants who met randomization criteria and randomized to receive aripiprazole matching-placebo tablets, 2 daily, orally, up to 12 weeks in Double-Blind Phase.
|
|---|---|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/36 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
11.1%
1/9 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
Other adverse events
| Measure |
Open Label Stabilization Phase: Aripiprazole
n=36 participants at risk
Participants began treatment with aripiprazole at a 2.0 mg/day dose, with the dose titrated to 5.0 mg/day after 2 days. Subsequent dose adjustments were based on the participant's weight to achieve optimum control of tics up to the maximum recommended doses based on the United States Labeling, up to Week 8 and then continued on the most stabilized dose up to minimum Week 14 or maximum Week 20. Participants who met stabilization criteria were randomized to Double-blind Randomization Phase.
|
Double Blind Phase: Aripiprazole Full Dose
n=9 participants at risk
Participants who met stabilization criteria and randomized to receive full dose of aripiprazole i.e. 5 mg or 10 mg for \<50 kg participants,and 10 mg or 20 mg for \>50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-blind Phase.
|
Double Blind Phase: Aripiprazole Half Dose
n=8 participants at risk
Participants who met stabilization criteria and randomized to receive half dose of aripiprazole i.e. 2 mg or 5 mg for \<50 kg participants, and 5 mg or 10 mg for \>50 kg participants (2 tablets a day), based on stabilized dose in open-label stabilization phase, up to 12 weeks in Double-Blind Phase.
|
Double Blind Phase: Placebo
n=8 participants at risk
Participants who met randomization criteria and randomized to receive aripiprazole matching-placebo tablets, 2 daily, orally, up to 12 weeks in Double-Blind Phase.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/36 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/9 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
12.5%
1/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
|
Nervous system disorders
Somnolence
|
13.9%
5/36 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/9 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
12.5%
1/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/36 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/9 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
12.5%
1/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
|
Psychiatric disorders
Enuresis
|
0.00%
0/36 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
11.1%
1/9 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
|
Cardiac disorders
Tachycardia
|
2.8%
1/36 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
11.1%
1/9 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/36 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/9 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
12.5%
1/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
1/36 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
11.1%
1/9 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/36 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/9 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
12.5%
1/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
|
Psychiatric disorders
Irritability
|
2.8%
1/36 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/9 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
12.5%
1/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
|
Psychiatric disorders
Restlessness
|
2.8%
1/36 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/9 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
12.5%
1/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
|
General disorders
Fatigue
|
19.4%
7/36 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/9 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
|
Investigations
Weight increased
|
8.3%
3/36 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/9 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
|
Nervous system disorders
Headache
|
5.6%
2/36 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/9 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
|
Nervous system disorders
Sedation
|
11.1%
4/36 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/9 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
|
Psychiatric disorders
Anxiety
|
5.6%
2/36 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/9 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
0.00%
0/8 • From first dose up to 30 days after last dose of study drug (Up to approximately 36 weeks)
Open-label Safety Sample included all participants that had administered at least 1 dose of IMP during the open-label stabilization phase. Randomized Safety Sample included all participants who received at least 1 dose of randomized IMP during the double-blind randomized withdrawal phase were included and analyzed according to the treatment received.
|
Additional Information
Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: 1-609-524-6788
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.
- Publication restrictions are in place
Restriction type: OTHER