Trial Outcomes & Findings for 28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years (NCT NCT00946985)

Last Updated: 2012-09-10

Results Overview

Time to relapse during the relapse prevention phase was the primary efficacy variable of the study. Each case of potential relapse event were to be reviewed in a blinded fasion by an independent Relapse Monitoring Board, comprised of experts in the diagnostic, clinical and therapeutic management of schizophrenia.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

163 participants

Primary outcome timeframe

24 months

Results posted on

2012-09-10

Participant Flow

This trial was intended to recruit patients from multiple sites in North America, Europe, and Asia.

Eligible patients were to be treated with paliperdione palmitate for up to 25 weeks (stabilization phase). Patients meeting stabilization criteria were to be randomized to either paliperidone palmitate or oral risperidone and be treated for 24 months (relapse prevention phase).

Participant milestones

Participant milestones
Measure	Paliperidone Palmitate 50, 75, 100, or 150 mg equivalent (eq.) monthly injection
Stabilization Phase (25 Weeks) STARTED	162
Stabilization Phase (25 Weeks) COMPLETED	2
Stabilization Phase (25 Weeks) NOT COMPLETED	160
Relapse Prevention Phase (24 Months) STARTED	2
Relapse Prevention Phase (24 Months) COMPLETED	0
Relapse Prevention Phase (24 Months) NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Paliperidone Palmitate 50, 75, 100, or 150 mg equivalent (eq.) monthly injection
Stabilization Phase (25 Weeks) Adverse Event	4
Stabilization Phase (25 Weeks) Lack of Efficacy	3
Stabilization Phase (25 Weeks) Lost to Follow-up	5
Stabilization Phase (25 Weeks) Withdrawal by Subject	4
Stabilization Phase (25 Weeks) Study Closed by Sponsor	139
Stabilization Phase (25 Weeks) Failed to Meet Stability Criteria	2
Stabilization Phase (25 Weeks) Prohibited Medication During Study	1
Stabilization Phase (25 Weeks) Patient Moved Away	2
Relapse Prevention Phase (24 Months) Study Closed by Sponsor	2

Baseline Characteristics

28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paliperidone Palmitate n=162 Participants 50, 75, 100, or 150 mg equivalent (eq.) monthly injection
Age Continuous	27 years STANDARD_DEVIATION 4.55 • n=5 Participants
Age, Customized 18-23 years	46 participants n=5 Participants
Age, Customized 24-29 years	62 participants n=5 Participants
Age, Customized 30-35 years	54 participants n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants
Sex: Female, Male Male	108 Participants n=5 Participants
Positive and Negative Syndrome Scale (PANSS) Total Score	85.9 units on a scale STANDARD_DEVIATION 13.65 • n=5 Participants
Clinical Global Impression of Severity (CGI-S)	4.4 units on a scale STANDARD_DEVIATION 0.56 • n=5 Participants
Age at First Diagnosis of Schizophrenia	24.1 years STANDARD_DEVIATION 4.61 • n=5 Participants
Current Schizophrenia Diagnosis Paranoid (295.30)	142 participants n=5 Participants
Current Schizophrenia Diagnosis Disorganized (295.10)	6 participants n=5 Participants
Current Schizophrenia Diagnosis Undifferentiated (295.90)	13 participants n=5 Participants
Current Schizophrenia Diagnosis Residual (295.60)	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: The analysis population was to include all randomized patients who took at least one dose of study medication (ITT population). However, due to early study termination, only 2 patients were randomized and they did not have sufficient follow up. Hence the planned efficacy analysis could not be carried out.

Outcome measures

Outcome data not reported

Adverse Events

Paliperidone Palmitate

Serious events: 6 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Paliperidone Palmitate n=162 participants at risk 50, 75, 100, or 150 mg equivalent (eq.) monthly injection
Psychiatric disorders Schizophrenia	2.5% 4/162
Psychiatric disorders Aggression	0.62% 1/162
Psychiatric disorders Depression	0.62% 1/162
Psychiatric disorders Self Injurious Behaviour	0.62% 1/162
Injury, poisoning and procedural complications Hand Fracture	0.62% 1/162

Other adverse events

Other adverse events
Measure	Paliperidone Palmitate n=162 participants at risk 50, 75, 100, or 150 mg equivalent (eq.) monthly injection
Psychiatric disorders Insomnia	6.2% 10/162
Psychiatric disorders Agitation	4.9% 8/162
Psychiatric disorders Anxiety	4.9% 8/162
Psychiatric disorders Restlessness	2.5% 4/162
Nervous system disorders Headache	4.9% 8/162
Nervous system disorders Tremor	4.9% 8/162
Nervous system disorders Akathisia	3.1% 5/162
General disorders Injection Site Pain	6.2% 10/162
Investigations Weight Increased	4.9% 8/162
Musculoskeletal and connective tissue disorders Pain in Extremity	3.1% 5/162

Additional Information

Clinical Project Scientist

Ortho-McNeil Janssen Scientific Affairs, LLC

Phone: 609-730-3229

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place