Trial Outcomes & Findings for Paliperidone Extended Release in Schizophrenia Participants With Duration of Illness Less Than 10 Years (NCT NCT01362439)
NCT ID: NCT01362439
Last Updated: 2013-06-05
Results Overview
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.
COMPLETED
PHASE4
133 participants
Baseline and Week 13
2013-06-05
Participant Flow
Participant milestones
| Measure |
Paliperidone ER
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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|---|---|
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Overall Study
STARTED
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133
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Overall Study
COMPLETED
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118
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Overall Study
NOT COMPLETED
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15
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Reasons for withdrawal
| Measure |
Paliperidone ER
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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|---|---|
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Overall Study
Adverse Event
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1
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Overall Study
Lack of Efficacy
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3
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Overall Study
Lost to Follow-up
|
2
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Overall Study
Study medication non-compliant
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1
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Overall Study
Participant who withdrew consent
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8
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Baseline Characteristics
Paliperidone Extended Release in Schizophrenia Participants With Duration of Illness Less Than 10 Years
Baseline characteristics by cohort
| Measure |
Paliperidone ER
n=132 Participants
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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Age Continuous
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35.3 years
STANDARD_DEVIATION 6.76 • n=5 Participants
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Sex: Female, Male
Female
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41 Participants
n=5 Participants
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Sex: Female, Male
Male
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91 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and Week 13Population: Intent to Treat Population (ITT) included all participants who received at least 1 dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using Last observation carried forward (LOCF) method.' N' (number of participants analyzed): participants evaluable for this measure.
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.
Outcome measures
| Measure |
Paliperidone ER
n=126 Participants
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13
Baseline
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88.98 units on a scale
Standard Deviation 10.126
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13
Change at Week 13
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22.468 units on a scale
Standard Deviation 17.287
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SECONDARY outcome
Timeframe: Baseline and Week 13Population: The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.
The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Outcome measures
| Measure |
Paliperidone ER
n=132 Participants
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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|---|---|
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Change in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 13
Baseline
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21.03 units on a scale
Standard Deviation 5.2
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Change in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 13
Change at Week 13
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-6.55 units on a scale
Standard Deviation 5.3
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SECONDARY outcome
Timeframe: Baseline and Week 13Population: The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.
The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Outcome measures
| Measure |
Paliperidone ER
n=132 Participants
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 13
Baseline
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23.11 units on a scale
Standard Deviation 6.4
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 13
Change at Week 13
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-4.82 units on a scale
Standard Deviation 5.6
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SECONDARY outcome
Timeframe: Baseline and Week 13Population: The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.
The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).
Outcome measures
| Measure |
Paliperidone ER
n=132 Participants
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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Change in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 13
Baseline
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44.84 units on a scale
Standard Deviation 6.5
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Change in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 13
Change at Week 13
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-11.31 units on a scale
Standard Deviation 8.7
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SECONDARY outcome
Timeframe: Baseline and Week 13Population: The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method. 'N' (number of participants analyzed) signified participants evaluable for this measure.
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.
Outcome measures
| Measure |
Paliperidone ER
n=126 Participants
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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Percentage of Participants With Greater Than or Equal to 30 Percent Treatment Response in Total Positive and Negative Syndrome Scale (PANSS) Score
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40.5 percentage of participants
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SECONDARY outcome
Timeframe: Baseline and Week 13Population: The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.
The SWN 20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.
Outcome measures
| Measure |
Paliperidone ER
n=132 Participants
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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Change From Baseline in Subjective Well-being Under Neuroleptic (SWN 20) Scale at Week 13
Baseline
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73.81 units on a scale
Standard Deviation 15.4
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Change From Baseline in Subjective Well-being Under Neuroleptic (SWN 20) Scale at Week 13
Change at Week 13
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6.86 units on a scale
Standard Deviation 12.8
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SECONDARY outcome
Timeframe: Baseline and Week 13Population: The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.
The DAI is a 30-item self-rating inventory that focuses on subjective effects of neuroleptic medications in participants with schizophrenia. There are 15 items that are scored as true and 15 scored as false if the person is fully compliant (positive subjective response). Positive answers score as +1, negative answers score as - 1. Questionnaire allows identifying participants at high risk of low compliance. The total score may vary from -30 to +30 with a high total final score is a positive subjective response (compliant) and a low total score is a negative subjective response (non-compliant).
Outcome measures
| Measure |
Paliperidone ER
n=132 Participants
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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Change From Baseline in Drug Attitude Inventory (DAI 30) Scale at Week 13
Change at Week 13
|
2.0 units on a scale
Standard Deviation 5.4
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Change From Baseline in Drug Attitude Inventory (DAI 30) Scale at Week 13
Baseline
|
41.20 units on a scale
Standard Deviation 5.4
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SECONDARY outcome
Timeframe: Baseline and Week 13Population: The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post Baseline was used for final evaluation using LOCF method.
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 scores indicate worsening.
Outcome measures
| Measure |
Paliperidone ER
n=132 Participants
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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Clinical Global Impression-Severity Scale (CGI-S)
Baseline
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4 units on a scale
Interval 2.0 to 6.0
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Clinical Global Impression-Severity Scale (CGI-S)
Week 13
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3 units on a scale
Interval 1.0 to 6.0
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SECONDARY outcome
Timeframe: Baseline and Week 13Population: The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post Baseline was used for final evaluation using LOCF method.
The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).
Outcome measures
| Measure |
Paliperidone ER
n=132 Participants
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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Change From Baseline in Personal and Social Performance Scale (PSP) at Week 13
Baseline
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56.54 units on a scale
Standard Deviation 12.47
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Change From Baseline in Personal and Social Performance Scale (PSP) at Week 13
Change at Week 13
|
9.05 units on a scale
Standard Deviation 10.5
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SECONDARY outcome
Timeframe: Baseline and Week 13Population: The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.
This self-administered scale rates quality of sleep and daytime drowsiness. Participants indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time). On the sleep evaluation scale, score 0 corresponds to very badly and score 10 to very well.
Outcome measures
| Measure |
Paliperidone ER
n=132 Participants
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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Quality of Sleep Score
Baseline
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6.22 units on a scale
Standard Deviation 2.5
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Quality of Sleep Score
Week 13
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7.08 units on a scale
Standard Deviation 2.1
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SECONDARY outcome
Timeframe: Baseline and Week 13Population: ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.
This self-administered scale rates quality of sleep and daytime drowsiness. Participants will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).On the daytime drowsiness scale, score 0 corresponds to not at all and score 10 to all the time.
Outcome measures
| Measure |
Paliperidone ER
n=132 Participants
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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Daytime Drowsiness Evaluation Scale
Baseline
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4.09 units on a scale
Standard Deviation 2.4
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Daytime Drowsiness Evaluation Scale
Week 13
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3.30 units on a scale
Standard Deviation 2.5
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SECONDARY outcome
Timeframe: Baseline and Week 13Population: Safety population included all participants who received atleast one dose of study medication.
Extra pyramidal symptoms attributed to antipsychotic assessed by ESRS scale. Included 4 subscales; Parkinsonism (Park),dystonia(Dyst),dyskinesia(Dysk),akathisia(Akat),12 items on 4-point scale; (0=absent-3=severe); Park (8 items); Dyst (2 items); Dysk (7 items) all 3 rated on 7-point scale (0=none/normal-6=worst). Additionally, subtotals were calculated; hyperkinesia (item 5, 6 of Park); hypokinesia (item 1-4, 7 of Park); bucco-linguo-masticatory (item 1-3 of Dysk), choreoathetoid movement (item 5, 6 of Dysk). Total score: sum of Park, Dyst \& Dysk subscale, ranged from 0 (normal)-102 (severe).
Outcome measures
| Measure |
Paliperidone ER
n=132 Participants
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Week 13: ESRS Total Score
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2.21 units on a scale
Standard Deviation 4.6
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Baseline: Park, Dyst, Dysk and Akat
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1.86 units on a scale
Standard Deviation 2.6
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Week 13: Park, Dyst, Dysk and Akat
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0.56 units on a scale
Standard Deviation 1.1
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Baseline: Park
|
4.30 units on a scale
Standard Deviation 7.3
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Baseline: Dyst
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0.66 units on a scale
Standard Deviation 3.4
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Week 13: Dyst
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0.15 units on a scale
Standard Deviation 1.0
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Baseline: Dysk Movements
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0.58 units on a scale
Standard Deviation 1.7
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Week 13: Dysk Movements
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0.18 units on a scale
Standard Deviation 0.5
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Baseline: Hyperkinesia
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1.43 units on a scale
Standard Deviation 3.4
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Week 13: Hyperkinesia
|
0.44 units on a scale
Standard Deviation 1.3
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Baseline: Hypokinesia
|
2.66 units on a scale
Standard Deviation 4.4
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Week 13: Hypokinesia
|
0.80 units on a scale
Standard Deviation 1.6
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Baseline: Bucco-Linguo-Masticatory
|
0.21 units on a scale
Standard Deviation 0.7
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Week 13: Bucco-Linguo-Masticatory
|
0.05 units on a scale
Standard Deviation 0.25
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Baseline: Choreoathetoid movements of limbs
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0.20 units on a scale
Standard Deviation 0.6
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Week 13: Choreoathetoid movements of limbs
|
0.06 units on a scale
Standard Deviation 0.3
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Baseline: ESRS Total Score
|
7.39 units on a scale
Standard Deviation 13.2
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Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
Week 13: Park
|
1.33 units on a scale
Standard Deviation 2.8
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Adverse Events
Paliperidone ER
Serious adverse events
| Measure |
Paliperidone ER
n=132 participants at risk
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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|---|---|
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Nervous system disorders
Worsening of Schizophrenia
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
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Other adverse events
| Measure |
Paliperidone ER
n=132 participants at risk
Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
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|---|---|
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Cardiac disorders
Hypopiesia
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Cardiac disorders
Increased Blood Pressure
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Cardiac disorders
Tachicardia
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Skin and subcutaneous tissue disorders
Rash (Mycosis)
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
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Endocrine disorders
Galactorrhoea
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Endocrine disorders
Hyperthyroidism
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Metabolism and nutrition disorders
Weight Increase
|
3.0%
4/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Nervous system disorders
Agitation
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Nervous system disorders
Insomnia
|
3.0%
4/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Nervous system disorders
Akatisia
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Nervous system disorders
Anxiety
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Nervous system disorders
Extrapyramidal Symptoms
|
2.3%
3/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Nervous system disorders
Increased Anxiety
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Nervous system disorders
Increased Irritability
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Nervous system disorders
Jaw Movements
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Nervous system disorders
Lingual Movements
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Nervous system disorders
Lower Limbs Tremor
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Nervous system disorders
Psychomotor Agitation
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Nervous system disorders
Ptyalism
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Nervous system disorders
Slowness (Increased)
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Nervous system disorders
Worsening of Anxiety
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Nervous system disorders
Worsening of Bradikinesia
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
|
Nervous system disorders
Worsening of Tremor
|
0.76%
1/132 • Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
|
Additional Information
Therapeutic Area Medical Manager
Janssen-Cilag SpA, Cologno Monzese, Milan - Italy
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60