Clinical Trial Results:
A 28-week, randomised, open-label study evaluating the effectiveness of aripiprazole once-monthly versus paliperidone palmitate in adult patients with schizophrenia
Summary
|
|
EudraCT number |
2012-002785-12 |
Trial protocol |
SE IT DE ES CZ EE GB |
Global end of trial date |
29 Sep 2014
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
09 Jul 2016
|
First version publication date |
09 Jul 2016
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
14724A
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT01795547 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
H. Lundbeck
|
||
Sponsor organisation address |
Ottiliavej 9, Valby, Denmark, 2500
|
||
Public contact |
LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, +45 36301311, , LundbeckClinicalTrials@lundbeck.com
|
||
Scientific contact |
LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, +45 36301311, , LundbeckClinicalTrials@lundbeck.com
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
29 Sep 2014
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
29 Sep 2014
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
29 Sep 2014
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
To assess the effectiveness of aripiprazole once-monthly in the maintenance treatment of patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care setting by comparing it to an existing long-acting antipsychotic, paliperidone palmitate
|
||
Protection of trial subjects |
The trial was conducted in accordance with the Declaration of Helsinki (2008) and ICH Good Clinical Practice (1996)
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
28 Feb 2013
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
Yes
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Spain: 38
|
||
Country: Number of subjects enrolled |
Sweden: 8
|
||
Country: Number of subjects enrolled |
United Kingdom: 1
|
||
Country: Number of subjects enrolled |
Czech Republic: 28
|
||
Country: Number of subjects enrolled |
Estonia: 30
|
||
Country: Number of subjects enrolled |
Germany: 31
|
||
Country: Number of subjects enrolled |
Italy: 32
|
||
Country: Number of subjects enrolled |
United States: 100
|
||
Country: Number of subjects enrolled |
Canada: 12
|
||
Country: Number of subjects enrolled |
France: 15
|
||
Worldwide total number of subjects |
295
|
||
EEA total number of subjects |
183
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
295
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||||||||||||||||||||||||||||||||||||||
Recruitment
|
|||||||||||||||||||||||||||||||||||||||||||
Recruitment details |
- | ||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
|
|||||||||||||||||||||||||||||||||||||||||||
Screening details |
Subjects who met each of the inclusion and none of the exclusion criteria were eligible to participate in the study | ||||||||||||||||||||||||||||||||||||||||||
Period 1
|
|||||||||||||||||||||||||||||||||||||||||||
Period 1 title |
Overall Trial (overall period)
|
||||||||||||||||||||||||||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||||||||||||||||||||||||||
Blinding used |
Not blinded | ||||||||||||||||||||||||||||||||||||||||||
Arms
|
|||||||||||||||||||||||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Aripiprazol | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets was taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24 | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Aripiprazole (tablet)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
Abilify
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Tablet
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
5 to 30 mg/day during three week Oral Conversion. Followed by one week 10-30 mg/day. Then 400 mg injection followed by two weeks with 10-20 mg/day (5, 10, and 15 mg tablets, orally. )
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Aripiprazole (injection)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
Abilify
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Powder and solvent for prolonged-release suspension for injection
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
400 and 300 mg every 4 weeks (once-monthly). Total 6 times total during week 5 to 28
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Paliperidone | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Paliperidone
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Tablet
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
3 to 12 mg/day during three week Oral Conversion. (3, 6, and 9 mg tablets, orally. )
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Paliperidone (injection)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
Xeplion®, Invega®, Sustenna®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
150 mg and 300 mg every 4 weeks (once-monthly). Total 6 times total during week 5 to 28
|
||||||||||||||||||||||||||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Aripiprazol
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets was taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Paliperidone
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Aripiprazol
|
||
Reporting group description |
Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets was taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24 | ||
Reporting group title |
Paliperidone
|
||
Reporting group description |
Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI |
|
|||||||||||||
End point title |
Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score | ||||||||||||
End point description |
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline to Week 28
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Aripiprazol vs Paliperidone | ||||||||||||
Comparison groups |
Aripiprazol v Paliperidone
|
||||||||||||
Number of subjects included in analysis |
268
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other [1] | ||||||||||||
P-value |
= 0.036 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
4.666
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.316 | ||||||||||||
upper limit |
9.015 | ||||||||||||
Notes [1] - Non-inferiority of the primary endpoint was considered confirmed if the lower bound of the 2-sided 95% CI at Week 28 was > -5 or equivalently if the p-value for the 1-sided test of H0: D ≤ -5 against H1: D > -5 was ≤2.5%, where D was the mean treatment difference (aripiprazole minus paliperidone). Superiority was then tested as pre-specified with the FAS and demonstrated for aripiprazole over paliperidone, since the lower bound of the 95% CI was >0 |
|
|||||||||||||
End point title |
Investigator’s Assessment Questionnaire (IAQ) Total Score at Week 28 | ||||||||||||
End point description |
The IAQ is a clinician-rated scale designed to assess the relative effectiveness (efficacy, safety and tolerability) of antipsychotic medications in patients with schizophrenia or schizoaffective disorder. The IAQ consists of 12 items: positive symptoms, negative symptoms, other efficacy symptoms, cognition, energy, mood, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, EPS (other than akathisia) and other safety or tolerability issues. For each item, the current medication was compared with previous antipsychotic medication on a five-point scale from 1 (Much better) to 5 (Much worse), or that item is Not applicable. The sum of the 12 items ranged from 12 (the current medication was much better than previous antipsychotic medication) to 60 (the current medication was much worse than previous antipsychotic medication).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Week 28
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Aripiprazol vs Paliperidone | ||||||||||||
Comparison groups |
Aripiprazol v Paliperidone
|
||||||||||||
Number of subjects included in analysis |
264
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
P-value |
= 0.043 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-1.492
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-2.935 | ||||||||||||
upper limit |
-0.049 |
|
|||||||||||||
End point title |
Change From Baseline to Week 28 in CGI-S Score | ||||||||||||
End point description |
Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 28
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Aripiprazol vs Paliperidone | ||||||||||||
Comparison groups |
Aripiprazol v Paliperidone
|
||||||||||||
Number of subjects included in analysis |
268
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
P-value |
= 0.004 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-0.283
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.477 | ||||||||||||
upper limit |
-0.09 |
|
|||||||||||||
End point title |
Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score | ||||||||||||
End point description |
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 28
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Aripiprazol vs Paliperidone | ||||||||||||
Comparison groups |
Aripiprazol v Paliperidone
|
||||||||||||
Number of subjects included in analysis |
268
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
P-value |
= 0.149 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
0.331
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.12 | ||||||||||||
upper limit |
0.782 |
|
|||||||||||||
End point title |
Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score | ||||||||||||
End point description |
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 28
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Aripiprazol vs Paliperidone | ||||||||||||
Comparison groups |
Aripiprazol v Paliperidone
|
||||||||||||
Number of subjects included in analysis |
268
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
P-value |
= 0.039 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
1.753
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.093 | ||||||||||||
upper limit |
3.412 |
|
|||||||||||||
End point title |
Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score | ||||||||||||
End point description |
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 28
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Aripiprazol vs Paliperidone | ||||||||||||
Comparison groups |
Aripiprazol v Paliperidone
|
||||||||||||
Number of subjects included in analysis |
268
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
P-value |
= 0.07 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
1.764
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.143 | ||||||||||||
upper limit |
3.672 |
|
|||||||||||||
End point title |
Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain Score | ||||||||||||
End point description |
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 28
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Aripiprazol vs Paliperidone | ||||||||||||
Comparison groups |
Aripiprazol v Paliperidone
|
||||||||||||
Number of subjects included in analysis |
268
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
P-value |
= 0.13 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
0.922
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.275 | ||||||||||||
upper limit |
2.119 |
|
|||||||||||||
End point title |
Change From Baseline to Week 28 in SWN-S Total Score | ||||||||||||
End point description |
The SWN-S is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 28
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Aripiprazol vs Paliperidone | ||||||||||||
Comparison groups |
Aripiprazol v Paliperidone
|
||||||||||||
Number of subjects included in analysis |
268
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
P-value |
= 0.561 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
1.007
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-2.402 | ||||||||||||
upper limit |
4.417 |
|
|||||||||||||
End point title |
Change From Baseline to Week 28 in the TooL Total Score | ||||||||||||
End point description |
Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 28
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Aripiprazol vs Paliperidone | ||||||||||||
Comparison groups |
Aripiprazol v Paliperidone
|
||||||||||||
Number of subjects included in analysis |
268
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
P-value |
= 0.095 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-0.695
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-1.511 | ||||||||||||
upper limit |
0.121 |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
First dose to follow-up
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
PALIPERIDONE
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
PALIPERIDONE | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
ARIPIPRAZOLE
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
ARIPIPRAZOLE | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
09 Sep 2013 |
Adjustment of the study design (including the addition of up to 2 further cohorts and therefore a change in the number of subjects planned) to explore and better define the safety window of Lu AF34134
Timing of Change: Prior to Cohort 5 |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |