Trial Outcomes & Findings for A Study of Flexibly Dosed Paliperidone Extended Release Tablets in Participants With Schizophrenia (NCT NCT01541371)

Last Updated: 2013-08-07

Results Overview

PANSS is a medical scale that assesses various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions \[a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder\] and hallucinations \[imagining things\], and withdrawal into the self). The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

405 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2013-08-07

Participant Flow

Participants were recruited from 19 study centers between 30 July 2008 and 23 September 2009.

405 participants were enrolled, out of which 403 participants were recruited in Safety Analysis Set (randomized and took at least 1 dose of study drug) and 394 subjects were included in full analysis set (had at least 1 efficacy evaluation).

Participant milestones

Participant milestones
Measure	Paliperidone Extended Release (ER) Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator's discretion once daily for 12 weeks.
Overall Study STARTED	403
Overall Study Full Analysis Set	394
Overall Study COMPLETED	326
Overall Study NOT COMPLETED	77

Reasons for withdrawal

Reasons for withdrawal
Measure	Paliperidone Extended Release (ER) Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator's discretion once daily for 12 weeks.
Overall Study Withdrawal by Subject	14
Overall Study Lost to Follow-up	21
Overall Study Adverse Event	15
Overall Study Lack of Efficacy	12
Overall Study Protocol Violation	6
Overall Study Study medication non-compliance	3
Overall Study Other	6

Baseline Characteristics

A Study of Flexibly Dosed Paliperidone Extended Release Tablets in Participants With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paliperidone Extended Release (ER) n=394 Participants Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator's discretion once daily for 12 weeks.
Age Continuous	30.88 Years STANDARD_DEVIATION 10.39 • n=5 Participants
Sex: Female, Male Female	199 Participants n=5 Participants
Sex: Female, Male Male	195 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set (FAS) included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.

Outcome measures

Outcome measures
Measure	Lack of Efficacy Group n=238 Participants Paliperidone extended release (ER) tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale \[PANSS\] score more than \[\>\] or equal to \[=\] 70 or \>=2 items scoring \>=4 in the Positive or Negative Symptom Subscale or \>=3 items scoring \>=4 in the General Psychopathology Subscale).	Lack of Tolerability Group n=115 Participants Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).	Other Group n=41 Participants Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 Baseline	77.18 unit on a scale Standard Deviation 17.50	58.46 unit on a scale Standard Deviation 16.31	63.33 unit on a scale Standard Deviation 19.08
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 Change at Week 12	-26.29 unit on a scale Standard Deviation 20.77	-13.99 unit on a scale Standard Deviation 15.74	-20.90 unit on a scale Standard Deviation 18.20

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.

PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Positive syndrome subscale ranges from 7 to 49, higher change scores indicate worsening. Negative syndrome subscale ranges from 7 to 49, higher change scores indicate worsening. General Psychopathology subscale ranges from 16 to112, higher change scores indicate worsening.

Outcome measures

Outcome measures
Measure	Lack of Efficacy Group n=394 Participants Paliperidone extended release (ER) tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale \[PANSS\] score more than \[\>\] or equal to \[=\] 70 or \>=2 items scoring \>=4 in the Positive or Negative Symptom Subscale or \>=3 items scoring \>=4 in the General Psychopathology Subscale).	Lack of Tolerability Group Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).	Other Group Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12 Positive: Baseline	17.07 Units on a scale Standard Deviation 6.53	—	—
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12 Positive: Change at Week 12	-6.59 Units on a scale Standard Deviation 6.30	—	—
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12 Negative: Baseline	18.57 Units on a scale Standard Deviation 6.66	—	—
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12 Negative: Change at Week 12	-6.14 Units on a scale Standard Deviation 5.99	—	—
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12 General psychopathology: Baseline	34.44 Units on a scale Standard Deviation 9.75	—	—
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12 General psychopathology: Change at Week 12	-10.84 Units on a scale Standard Deviation 10.21	—	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.

The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28. Higher change score indicates greater severity.

Outcome measures

Outcome measures
Measure	Lack of Efficacy Group n=394 Participants Paliperidone extended release (ER) tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale \[PANSS\] score more than \[\>\] or equal to \[=\] 70 or \>=2 items scoring \>=4 in the Positive or Negative Symptom Subscale or \>=3 items scoring \>=4 in the General Psychopathology Subscale).	Lack of Tolerability Group Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).	Other Group Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12 Positive symptoms: Baseline	21.61 Units on a scale Standard Deviation 7.15	—	—
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12 Positive symptoms: Change at Week 12	-8.16 Units on a scale Standard Deviation 7.18	—	—
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12 Negative symptoms: Baseline	19.15 Units on a scale Standard Deviation 7.10	—	—
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12 Negative symptoms: Change at Week 12	-6.53 Units on a scale Standard Deviation 6.60	—	—
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12 Disorganized thoughts: Baseline	14.13 Units on a scale Standard Deviation 4.65	—	—
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12 Disorganized thoughts: Change at Week 12	-4.13 Units on a scale Standard Deviation 4.28	—	—
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12 Uncontrolled hostility/excitement: Baseline	7.73 Units on a scale Standard Deviation 3.83	—	—
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12 Uncontrolled hostility/excitement:Change at Week12	-2.74 Units on a scale Standard Deviation 3.63	—	—
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12 Anxiety/depression: Baseline	7.45 Units on a scale Standard Deviation 2.76	—	—
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12 Anxiety/depression: Change at Week 12	-2.00 Units on a scale Standard Deviation 2.67	—	—

SECONDARY outcome

Timeframe: Week 12

Population: FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.

Outcome measures

Outcome measures
Measure	Lack of Efficacy Group n=238 Participants Paliperidone extended release (ER) tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale \[PANSS\] score more than \[\>\] or equal to \[=\] 70 or \>=2 items scoring \>=4 in the Positive or Negative Symptom Subscale or \>=3 items scoring \>=4 in the General Psychopathology Subscale).	Lack of Tolerability Group n=115 Participants Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).	Other Group n=41 Participants Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
Percentage of Participants With Response to Positive and Negative Syndrome Scale (PANSS) Total Score	65.97 Percentage of participants Interval 59.95 to 71.99	51.72 Percentage of participants Interval 42.63 to 60.82	61.90 Percentage of participants Interval 47.22 to 76.59

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here "N" (Number of Participants Analyzed): number of participants who were evaluable for this measure. 'n': number of participants who were evaluable at given time point for each arm group, respectively.

The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "normal, not at all ill" and a rating of 7 is equivalent to "among the most extremely ill participants". Higher change scores indicate worsening.

Outcome measures

Outcome measures
Measure	Lack of Efficacy Group n=237 Participants Paliperidone extended release (ER) tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale \[PANSS\] score more than \[\>\] or equal to \[=\] 70 or \>=2 items scoring \>=4 in the Positive or Negative Symptom Subscale or \>=3 items scoring \>=4 in the General Psychopathology Subscale).	Lack of Tolerability Group n=115 Participants Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).	Other Group n=41 Participants Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12 Baseline (n=237,115,41)	4.54 units on a scale Standard Deviation 0.91	3.20 units on a scale Standard Deviation 1.11	3.86 units on a scale Standard Deviation 1.09
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12 Change at Week 12 (n=208,103,40)	-1.77 units on a scale Standard Deviation 0.09	-1.01 units on a scale Standard Deviation 0.14	-1.66 units on a scale Standard Deviation 0.23

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here 'n': number of participants who were evaluable at given time point for each arm group, respectively.

PSP assesses the degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =\<30, functioning so poorly as to require intensive supervision.

Outcome measures

Outcome measures
Measure	Lack of Efficacy Group n=238 Participants Paliperidone extended release (ER) tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale \[PANSS\] score more than \[\>\] or equal to \[=\] 70 or \>=2 items scoring \>=4 in the Positive or Negative Symptom Subscale or \>=3 items scoring \>=4 in the General Psychopathology Subscale).	Lack of Tolerability Group n=115 Participants Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).	Other Group n=41 Participants Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12 Baseline (n=238,115,41)	53.16 Units on a scale Standard Deviation 13.79	66.95 Units on a scale Standard Deviation 12.89	66.00 Units on a scale Standard Deviation 11.21
Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12 Change at Week 12 (n=205,106,40)	18.57 Units on a scale Standard Deviation 16.87	10.09 Units on a scale Standard Deviation 13.75	12.40 Units on a scale Standard Deviation 13.33

SECONDARY outcome

Timeframe: Baseline and Week 12

Participants assessed their satisfaction with paliperidone ER on a 5-point scale: 1 (very good), 2 (good), 3 (moderate), 4 (poor) and 5 (very poor).

Outcome measures

Outcome measures
Measure	Lack of Efficacy Group n=230 Participants Paliperidone extended release (ER) tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale \[PANSS\] score more than \[\>\] or equal to \[=\] 70 or \>=2 items scoring \>=4 in the Positive or Negative Symptom Subscale or \>=3 items scoring \>=4 in the General Psychopathology Subscale).	Lack of Tolerability Group n=113 Participants Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).	Other Group n=41 Participants Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
Number of Participants With Satisfaction With the Study Treatment Week 12, Satisfied (n=208,105,40)	93 Participants	51 Participants	18 Participants
Number of Participants With Satisfaction With the Study Treatment Baseline, Very satisfied (n=230,113,41)	1 Participants	3 Participants	0 Participants
Number of Participants With Satisfaction With the Study Treatment Baseline, Satisfied (n=230,113,41)	15 Participants	30 Participants	15 Participants
Number of Participants With Satisfaction With the Study Treatment Baseline, Generally satisfied (n=230,113,41)	84 Participants	58 Participants	25 Participants
Number of Participants With Satisfaction With the Study Treatment Baseline, Dissatisfied (n=230,113,41)	124 Participants	21 Participants	1 Participants
Number of Participants With Satisfaction With the Study Treatment Baseline, Very dissatisfied (n=230,113,41)	6 Participants	1 Participants	0 Participants
Number of Participants With Satisfaction With the Study Treatment Week 12, Very satisfied (n=208,105,40)	30 Participants	23 Participants	10 Participants
Number of Participants With Satisfaction With the Study Treatment Week 12, Generally satisfied (n=208,105,40)	62 Participants	24 Participants	10 Participants
Number of Participants With Satisfaction With the Study Treatment Week 12, Dissatisfied (n=208,105,40)	23 Participants	6 Participants	2 Participants
Number of Participants With Satisfaction With the Study Treatment Week 12, Very dissatisfied (n=208,105,40)	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Week 12

The self-administered sleep VAS scale (0-100 milimeter \[mm\]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).

Outcome measures

Outcome measures
Measure	Lack of Efficacy Group n=233 Participants Paliperidone extended release (ER) tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale \[PANSS\] score more than \[\>\] or equal to \[=\] 70 or \>=2 items scoring \>=4 in the Positive or Negative Symptom Subscale or \>=3 items scoring \>=4 in the General Psychopathology Subscale).	Lack of Tolerability Group n=115 Participants Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).	Other Group n=41 Participants Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Week 12 Quality of sleep score: Baseline (n=233,115,41)	60.76 mm Standard Deviation 26.70	75.89 mm Standard Deviation 20.24	70.31 mm Standard Deviation 22.40
Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Week 12 Quality of sleep: Change at Week 12 (n=202,106,40)	15.76 mm Standard Deviation 29.46	2.90 mm Standard Deviation 27.41	13.60 mm Standard Deviation 26.94
Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Week 12 Daytime drowsiness score: Baseline (n=233,115,41)	38.16 mm Standard Deviation 23.70	44.77 mm Standard Deviation 25.29	34.26 mm Standard Deviation 23.64
Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Week 12 Daytime drowsiness:Change at Week 12(n=202,106,40)	-15.76 mm Standard Deviation 27.52	-21.66 mm Standard Deviation 27.88	-18.10 mm Standard Deviation 26.87

Adverse Events

Paliperidone Extended Release (ER)

Serious events: 1 serious events

Other events: 227 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Paliperidone Extended Release (ER) n=403 participants at risk Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator's discretion once daily for 12 weeks.
Psychiatric disorders Depression	0.25% 1/403 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.

Other adverse events

Other adverse events
Measure	Paliperidone Extended Release (ER) n=403 participants at risk Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator's discretion once daily for 12 weeks.
Gastrointestinal disorders Nausea	3.7% 15/403 • Number of events 15 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Gastrointestinal disorders Vomiting	2.0% 8/403 • Number of events 8 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Gastrointestinal disorders Salivary hypersecretion	1.7% 7/403 • Number of events 8 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Gastrointestinal disorders Constipation	1.5% 6/403 • Number of events 6 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Gastrointestinal disorders Diarrhoea	1.5% 6/403 • Number of events 6 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
General disorders Fatigue	2.7% 11/403 • Number of events 14 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Hepatobiliary disorders Hepatic function abnormal	1.5% 6/403 • Number of events 6 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Infections and infestations Upper respiratory tract infection	3.7% 15/403 • Number of events 16 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Investigations Weight increased	4.2% 17/403 • Number of events 18 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Investigations Transaminases increased	2.2% 9/403 • Number of events 10 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Investigations Blood prolactin increased	1.5% 6/403 • Number of events 7 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Metabolism and nutrition disorders Obesity	2.0% 8/403 • Number of events 8 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Metabolism and nutrition disorders Increased appetite	1.5% 6/403 • Number of events 6 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Nervous system disorders Tremor	12.9% 52/403 • Number of events 56 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Nervous system disorders Dystonia	8.7% 35/403 • Number of events 40 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Nervous system disorders Extrapyramidal disorder	6.0% 24/403 • Number of events 28 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Nervous system disorders Dizziness	4.2% 17/403 • Number of events 20 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Nervous system disorders Headache	1.7% 7/403 • Number of events 9 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Psychiatric disorders Akathisia	18.4% 74/403 • Number of events 76 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Psychiatric disorders Somnolence	7.9% 32/403 • Number of events 33 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Psychiatric disorders Insomnia	6.5% 26/403 • Number of events 28 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Psychiatric disorders Sleep disorder	2.2% 9/403 • Number of events 9 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
Reproductive system and breast disorders Menstrual disorders	1.7% 7/403 • Number of events 7 • Baseline up to Week 12 An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.

Additional Information

Therapeutic Area Manager

CDMA, Beijing

Phone: 00861058218352

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER