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| ID | Type | Description | Link |
|---|---|---|---|
| R092670PSY3015 | Other Identifier | Janssen Research & Development, LLC | |
| 2017-001941-28 | EudraCT Number |
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The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).
The primary hypothesis of this study is that the efficacy of PP6M is non-inferior to PP3M for preventing relapse in participants with schizophrenia who were previously stabilized on corresponding doses of PP1M or PP3M. The study consists of mainly 3 phases: a screening phase (up to 28 days), a maintenance phase (of 1 or 3 months), and a double-blind phase (of 12 months [neither the researchers nor the participants know what treatment the participant is receiving]). Additional/conditional phases include a transition phase (before maintenance phase). Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, and safety. The study duration will vary from approximately 13 months to 19 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PP1M: Transition Phase | Experimental | Participants who previously have not achieved stability with moderate to higher doses of Paliperidone palmitate 1-month (PP1M) or Paliperidone palmitate 3-month (PP3M) will enter into a transition period of up to 4 months. During transition period participants will receive 1 to 5 injections of PP1M 50 to 100 milligrams equivalent (mg eq.). The participants who achieved stability (stability is defined as at least 3 months of injections with the last 2 doses being the same strength) with PP1M 100 mg eq. will precede from transition phase to maintenance phase. |
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| PP1M/PP3M: Maintenance Phase | Experimental | All the participants will receive only 1 dose of PP1M 100 or 150 mg eq. or PP3M 350 or 525 mg eq. The participants will precede from maintenance phase to double-blind phase. |
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| PP6M or Placebo: Double-Blind Phase | Experimental | Participants will receive intramuscular injection of PP6M in left gluteal muscle on Day 1 and right gluteal muscle on Day 183 with alternating placebo in right gluteal muscle on Day 92 and left gluteal muscle on Day 274. |
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| PP3M: Double-Blind Phase | Experimental | Participants will receive intramuscular injections of PP3M at dose of 350 mg eq. or 525 mg eq. in left gluteal muscle on Day 1 and 274 and right gluteal muscle on Day 92 and 183. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PP6M | Drug | Participants will receive intramuscular injection of PP6M. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Relapse During the Double-Blind (DB) Phase | Time to relapse is time between participant randomization in DB Phase and first documentation of relapse event by end of Month 12 of DB phase. Relapse is defined as: a) Psychiatric hospitalization; b) Positive and Negative Syndrome Scale (PANSS) total score: Increase of 25 percentage (%), 10 point increase in PANSS for 2 analysis separated by 3-7 days if score was greater than (>) 40, less than or equal to (<=)40; c) Participants inflicted knowing self-injury/shown violent behavior leading to suicide, clinically significant injury to him/herself or other person/property; d) Participants had suicidal/homicidal ideation/violent behavior that was clinically significant as per investigator; e) PANSS items P1- delusions, P2- conceptual disorganization, P3-hallucinatory behavior, P6- suspiciousness/ persecution, P7-hostility, G8-uncooperativeness: score: greater than or equal to (>=)5, >=6 for 2 analysis separated by 3-7 days on any items if maximum score for PANSS: <=3 or 4, respectively. | Up to 12 months of DB Phase |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score | The neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale, which provides a total score (sum of the scores for all 30 items) and scores for 3 subscales: the 7-item positive-symptom (P) subscale, the 7-item negative-symptom (N) subscale, and the 16-item general-psychopathology symptom (G) subscale. Each item is rated on a scale from 1 (absent) to 7 (extreme). The PANSS total score ranges from 30 (absent disease)-210 (more severe neuropsychiatric symptoms of schizophrenia). |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland Research Northwest | Rogers | Arkansas | 72758 | United States | ||
| California Pharmaceutical Research Institute, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39511777 | Derived | Correll CU, Johnston KL, Turkoz I, Kutch M, Knight RK, Doring M, Sajatovic M. Comparing two transitioning strategies to paliperidone palmitate once-every-6-months. CNS Spectr. 2024 Dec;29(6):633-639. doi: 10.1017/S1092852924000476. Epub 2024 Nov 8. | |
| 37653768 | Derived | Richarz U, Han J, Bai YM, Yu-Hai Chen E, Chung YC, Jhanwar VG, Kim SW, Sulaiman AH, Knight K, Gopal S. Efficacy and safety of paliperidone palmitate 6-monthly long-acting injectable in reduction of relapses in patients with schizophrenia: An Asian subgroup analysis of phase 3, randomized study. Medicine (Baltimore). 2023 Aug 25;102(34):e34623. doi: 10.1097/MD.0000000000034623. |
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Total 841 participants were enrolled, out of which 838 participants received treatment. 2 participants were enrolled but did not receive treatment and 1 participant withdrew from the Open-label Phase and as permitted per the protocol, re-entered the study (under a different participant identifier) and was counted twice in the total. Per the rules specified in statistical analysis plan, only data collected during the second study participation was included in data summary for this participant.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-Label (OL) PP1M/PP3M | Participants previously treated with oral antipsychotics, or injectable risperidone, or a moderate or higher dose of paliperidone palmitate 1-month (PP1M) with previous initiation but without previous stabilization (where stabilization was defined as at least 3 months of injections with the last 2 doses being the same strength) received 1 to 5 intramuscular (IM) injections of PP1M 50 to 150 milligrams equivalent (mg eq.). Participants received single dose of IM injection of PP1M as 100 or 150 mg eq. or PP3M as 350 or 525 mg eq during the OL-maintenance phase. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-Label Phase |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 11, 2019 | Nov 11, 2021 |
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| PP3M 350 mg eq. | Drug | Participants will receive intramuscular injection of PP3M 350 mg eq. |
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| PP3M 525 mg eq. | Drug | Participants will receive intramuscular injection of PP3M 525 mg eq. |
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| PP1M | Drug | Participants will receive intramuscular injection of PP1M 50 to 150 mg eq. |
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| Placebo | Other | Participants will receive matching placebo. |
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| Baseline (DB) to 12 Months of DB Phase |
| Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score | CGI-S is defined as clinician-rated scale that assesses the severity of mental illness on a scale of 0 to 7. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to:1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill patients. A higher score implies a more severe condition. | Baseline (DB) to 12 Months of DB Phase |
| Change From Baseline in the Personal and Social Performance (PSP) Scale Total Score | The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Each domain was assessed on a 6-point scale, from 1 (absent) to 6 (very severe) (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe). PSP total score was calculated as sum of all the domain scores and ranges from 1 to 100. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Higher score indicates better performance. | Baseline (DB) to 12 Months of DB Phase |
| Percentage of Participants With Symptomatic Remission Based on PANSS Score During DB Phase | Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity. The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. | Up to 12 months of DB Phase |
| Change From Baseline in the Satisfaction With Participants in Social Roles (SPSR) Score | The SPSR Short Form 8a is a participant-reported outcome used to assess the satisfaction with participation in social roles. The participants were asked to rate 8 items on 5-point Likert scale, with scores ranging from 8 to 40, where higher scores represents higher satisfaction. | Baseline (DB) to 12 Months of DB Phase |
| Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score | TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions were calculated and used for analysis. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction. | Baseline (DB) to 12 Months of DB Phase |
| Change From Baseline in the Simpson-Angus Rating Scale (SAS) Total Score | The SAS rates 10 items for general extrapyramidal symptoms (EPS) on a 5-point scale from 0 (normal) to 4 (extreme), including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head rotation, Glabellar tap, tremor, and salivation. The SAS total score is the average score (total sum of item scores divided by the number of items) and ranges between 0 and 4. Negative change in score indicates improvement. Higher scores denote more severe condition of EPS. | Baseline (DB) to 12 Months of DB Phase |
| Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score | BARS is used to rate observable, restless movements of drug induced akathisia and subjective awareness of restlessness and any distress associated with the akathisia. BARS consists of the following 4 items: objective assessment of akathisia symptoms, subjective assessment of the participants's awareness of inner restlessness, distress restlessness, and global clinical assessment of akathisia. First three items are rated on a 4-point scale ranging from 0 (no abnormal movements or absence of inner restlessness or no distress) to 3 (severe akathisia or awareness of intense compulsion to move most of the time or severe distress). The last item, the global clinical assessment of akathisia, is rated on a 6-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). | Up to 12 Months of DB Phase |
| Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Total Score | AIMS is a 14-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 to 14 are yes/no questions regarding the global judgement and dental status of the participant. The total score is the sum of the scores for the 14 items and the possible total score ranges from 0 to 44. A higher total score is indicative of more severe dyskinetic movements. | Baseline (DB) to 12 Months of DB Phase |
| Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | The C-SSRS is a questionnaire used for suicide risk assessment. Affirmative or negative responses are provided to items 1 to 5 for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods [not plan] without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and items 6 to 10 for suicide behavior (6. Preparatory acts or behavior, 7. Aborted attempt, 8. Interrupted attempt, 9. Actual attempt, 10. Completed suicide). Total score ranges from 1 to 10. Higher scores indicate more severe suicidal ideation. | Baseline and endpoint (12 Months of DB Phase) |
| Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | Number of participants with treatment-emergent abnormal ECG values were reported. It includes heart rate (abnormally low refers to less than or equal to [<=] 50 beats per minute (bpm) , abnormally high refers greater than or equal to [>=] 100 bpm), pulse rate (PR) interval (abnormally high refers to >= 210 milliseconds [msec]), QRS interval (abnormally Low refers to <= 50, abnormally high refers to >= 120 msec) and QT interval (abnormally low refers to <= 200, abnormally high >= 500 msec). | Baseline (DB) to 12 Months of DB Phase |
| Change From Baseline in the Body Mass Index (BMI) During DB Phase | Change from baseline in BMI was reported. | Baseline (DB) to 12 Months of DB Phase |
| Change From Baseline in the Waist Circumference During DB Phase | Change from baseline in waist circumference was reported. | Baseline (DB) to 12 Months of DB Phase |
| Change From Baseline in the Body Weight During DB Phase | Change from baseline in body weight was reported. | Baseline (DB) to 12 Months of DB Phase |
| Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase | Change from baseline vital signs (pulse rate) were reported. This included supine pulse rate, standing pulse rate and supine-standing pulse rate. | Baseline (DB) to 12 Months of DB Phase |
| Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase | Change from baseline in vital signs including SBP and DBP (supine/standing) were reported. | Baseline (DB) to 12 Months of DB Phase |
| Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase | The neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale, which provides a total score (sum of the scores for all 30 items) and Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology). | Baseline (DB) to 12 Months of DB Phase |
| Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Number of participants with clinically significant abnormal laboratory values in chemistry included alanine aminotransferase (Unit per Litre [U/L]), albumin (Gram per Litre [g/L]), alkaline phosphatase (U/L), aspartate aminotransferase (U/L), bicarbonate (millimoles per litre [mmol/L]), bilirubin (micromoles per litre [umol/L]), calcium (mmol/L), chloride (mmol/L), cholesterol (mmol/L), creatinine (umol/L), gamma glutamyl transferase (GGT) (U/L), glucose (mmol/L), high-density lipoproteins (HDL) cholesterol (mmol/L), low density lipoproteins (LDL) cholesterol (mmol/L), lactate dehydrogenase (U/L), phosphate (mmol/L), potassium (mmol/L), protein (mmol/L), sodium (mmol/L), triglycerides (mmol/L), urate (umol/L), urea nitrogen (mmol/L) were reported. Here, ABL signifies abnormally low and ABH signifies abnormally high levels. | Up to 12 Months of DB Phase |
| Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Number of participants with clinically significant abnormal laboratory values in hematology included hemoglobin (Hb), hematocrit (Hct), red blood cell (RBC) count, white blood cell (WBC) count with differential, platelets, hemoglobin A1c. Here, ABL signifies abnormally low and ABH signifies abnormally high levels. | Up to 12 Months of DB Phase |
| Anaheim |
| California |
| 92804 |
| United States |
| ATP Clinical Research | Costa Mesa | California | 92626 | United States |
| Collaborative NeuroScience Network | Garden Grove | California | 92845 | United States |
| Synergy East | Lemon Grove | California | 91945 | United States |
| Pacific Research Partners | Oakland | California | 94607 | United States |
| SF-Care, Inc | San Rafael | California | 94901 | United States |
| New Life Medical Research Center, Inc. | Hialeah | Florida | 33012 | United States |
| Clintex Research Group | Miami | Florida | 33135 | United States |
| Florida Research Center Inc. | Miami | Florida | 33174 | United States |
| Olympian Clinical Research | Tampa | Florida | 33614 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Uptown Research Institute | Chicago | Illinois | 60640 | United States |
| Alexian Behavioral Health Hospital | Hoffman Estates | Illinois | 60169 | United States |
| Ascension via Christi Research | Wichita | Kansas | 67214 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Cherry Street Services, Inc. | Grand Rapids | Michigan | 49503 | United States |
| St. Louis Clinical Trials | St Louis | Missouri | 63141 | United States |
| The Zucker Hillside Hospital | Glen Oaks | New York | 11004 | United States |
| Clinical Trials of America Inc | Hickory | North Carolina | 28601 | United States |
| Wexner Medical Center at the Ohio State University | Columbus | Ohio | 43210 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Future Search Trials of Dallas | Dallas | Texas | 75231 | United States |
| Psychiatric and Behavioral Solutions | Salt Lake City | Utah | 84105-2425 | United States |
| Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales | Buenos Aires | C1133AAH | Argentina |
| CEN | Córdoba | X5004FJF | Argentina |
| Sanatorio Prof. Leon S. Morra | Córdoba | X5009BIN | Argentina |
| Instituto de Neurociencias San Agustin | La Plata | 1900 | Argentina |
| Clinica Privada de Salud Mental Santa Teresa de Ávila | La Plata | B1904ADM | Argentina |
| C I A P Centro de investigacion y Asistencia en Psiquiatria | Rosario | 2000 | Argentina |
| The Lyell McEwin Hospital | Elizabeth Vale | 5112 | Australia |
| Neuro Trials Victoria | Noble Park | 3174 | Australia |
| Trial Tech Tecnologia em Pesquisas com Medicamentos | Curitiba | 80240-280 | Brazil |
| Instituto Bairral de Psiquiatria | Itapira | 13970-905 | Brazil |
| Hospital das Clinicas de Porto Alegre | Porto Alegre | 90035-903 | Brazil |
| Ruschel Medicina e Pesquisa Clínica Ltda | Rio de Janeiro | 22270 060 | Brazil |
| CPQuali Pesquisa Clinica LTDA ME | São Paulo | 01228-900 | Brazil |
| SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo | São Paulo | 04020-060 | Brazil |
| Hospital Das Clinicas Da Faculdade De Medicina Da USP | São Paulo | 05403-903 | Brazil |
| Mental Health Center Prof. Dr. Ivan Temkov | Burgas | 8001 | Bulgaria |
| State Psychiatric Hospital Pazardzhik | Pazardzhik | 4400 | Bulgaria |
| UMHAT 'Sveti Georgi'-Plovdiv | Plovdiv | 4002 | Bulgaria |
| State Psychiatric HospitalDr.Georgi Kissiov | Radnevo | 6260 | Bulgaria |
| Centre for Mental Health Prof.N.Shipkovenski EOOD | Sofia | 1377 | Bulgaria |
| Medical Center Intermedica, OOD | Sofia | 1680 | Bulgaria |
| Psychiatricka ambulance, MUDr. Marta Holanova | Brno | 61500 | Czechia |
| NeuropsychiatrieHK, s.r.o. | Hradec Kralove-Vekose | 50341 | Czechia |
| A Shine S R O | Pilsen | 31200 | Czechia |
| Pragtis S R O | Prague | 12000 | Czechia |
| Institut Neuropsychiatricke pece | Prague | 18600 | Czechia |
| Psychiatricka ambulance MUDr. Simona Papezova | Prague | 19000 | Czechia |
| C.H.S. Charles Perrens | Bordeaux | 33076 | France |
| CHRU La Colombière | Montpellier | 34090 | France |
| CHU Caremeau | Nîmes | 30029 | France |
| Hopital Sainte Anne | Paris | 75674 | France |
| Hopital Sainte Musse | Toulon | 83000 | France |
| Kwai Chung Hospital | Hong Kong | Hong Kong |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Józsefvarosi Szent Kozma Egészségügyi Központ | Budapest | 1084 | Hungary |
| Petz Aladar Megyei Oktato Korhaz | Győr | 9023 | Hungary |
| Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza | Kalocsa | 6300 | Hungary |
| CRU Hungary Kft. | Miskolc | 3529 | Hungary |
| Ratandeep Multispeciality Hospital | Ahmedabad | 380008 | India |
| Sri Ramachandra Medical Centre | Chennai | 600116 | India |
| Asha hospital | Hyderabad | 500034 | India |
| Ahana Hospitals | Madurai | 625020 | India |
| Vinaya Hospital and Research Center | Mangalore | 575003 | India |
| Kasturba Medical College Hospital | Manipal | 576104 | India |
| Jehangir Clinical Development Center Pvt Ltd | Pune | 411001 | India |
| Deva Institute of Health Care and Research Pvt Ltd | Varanasi | 221005 | India |
| Clinica Psichiatrica - Università di Cagliari | Cagliari | 09127 | Italy |
| Dipartimento di Salute Mentale | Lecce | 73100 | Italy |
| Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria | Naples | 80138 | Italy |
| Universita degli Studi di Roma 'La Sapienza' - Azienda Ospedaliera Sant Andrea | Roma | 00189 | Italy |
| Hospital Bahagia Ulu Kinta | Ipoh | 31250 | Malaysia |
| Hospital Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
| Sarawak General Hospital | Kuching | 93586 | Malaysia |
| Gabipros SC | Mexico City | 07810 | Mexico |
| Instituto Neuropsique | Monterrey | 64610 | Mexico |
| Centro de Estudios Clinicos y Especialidades Medicas S C | Monterrey | 64620 | Mexico |
| Infosame/Research | Monterrey | 64710 | Mexico |
| Centro de Atencion e Investigacion Cardiovascular del Potosi S C | San Luis Potosí City | 78200 | Mexico |
| Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk | Bialystok | 15-404 | Poland |
| Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski | Bialystok | 15-464 | Poland |
| Zespol Opieki Zdrowotnej w Chelmnie | Chełmno | 86-200 | Poland |
| Centrum Badan Klinicznych PI House sp z o o | Gdansk | 80 546 | Poland |
| Szpital Specjalistyczny im H Klimontowicza Oddzial Psychiatryczny | Gorlice | 38-300 | Poland |
| Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS | Leszno | 64-100 | Poland |
| Centrum Medyczne Luxmed Sp z o o | Lublin | 20 109 | Poland |
| Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim | Pruszcz Gdański | 83-000 | Poland |
| Mazowieckie Specjalistyczne Centrum Zdrowia im. Prof. Jana Mazurkiewicza w Pruszkowie | Pruszków | 05-802 | Poland |
| Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu | Torun | 87 100 | Poland |
| Clinical Psychiatric Hospital #3 Named After V.A. Gilyarovsky | Moscow | 107076 | Russia |
| Psychiatric Clinical hospital 1 named after N.A. Alekseev | Moscow | 117152 | Russia |
| Nizny Novgorod clinical psychiatric hospital 1 | Nizny Novgorod | 603155 | Russia |
| Psychoneurological Dispensary of Frunzensky District | Saint Petersburg | 190013 | Russia |
| Psychoneurological dispensary 10 | Saint Petersburg | 190121 | Russia |
| St-Petersburg Bekhterev Psychoneurological Research Institute | Saint Petersburg | 192109 | Russia |
| Psychoneurological dispensary 1 | Saint Petersburg | 199178 | Russia |
| SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky | Saratov | 410028 | Russia |
| Saratov Regional Psychiatric hospital named after St. Sofia | Saratov | 410060 | Russia |
| Psychoneurological Dispensary #4 | St.Peterburg | 197110 | Russia |
| Research Institute of Mental Health | Tomsk | 634014 | Russia |
| Sverdlovsk Regional Clinical Psychiatric Hospital | Yekaterinburg | Russia |
| Flexivest 14 Research | Cape Town | 7550 | South Africa |
| Gert Bosch Pretoria South Africa | Pretoria | 0042 | South Africa |
| Juan Schrönen - Western Cape South Africa | Welgemoed | 7530 | South Africa |
| Chonnam National University Hospital | Gwangju | 61469 | South Korea |
| CHA Bundang Medical Center, CHA University | Gyeonggi-do | 13496 | South Korea |
| Chonbuk National Univ Hospital | Jeonju | 54907 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Hosp Univ Vall D Hebron | Barcelona | 08035 | Spain |
| Inst. Internac. Neurociencias Aplicadas | Barcelona | 8006 | Spain |
| Hosp. Univ. de Basurto | Bilbao | 48013 | Spain |
| Centro Salud Mental La Corredoria | Oviedo | 33011 | Spain |
| Hosp. El Bierzo | Ponferrada | 24404 | Spain |
| Hosp. Clinico Univ. de Valencia | Valencia | 46010 | Spain |
| Hosp. Prov. de Zamora | Zamora | 49021 | Spain |
| National Cheng Kung University Hospital | Tainan | 70403 | Taiwan |
| Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Chang Gung Memorial Hospital | Taoyuan | 333 | Taiwan |
| Abdurrah Yurtarslan Training and Research Hospital | Ankara | 6200 | Turkey (Türkiye) |
| Ankara Numune Research and Training Hospital | Ankara | 6800 | Turkey (Türkiye) |
| Erenkoy Mental Health Hospital | Istanbul | 34736 | Turkey (Türkiye) |
| Selcuk University, Medical School, Department of Psychiatry | Konya | 42130 | Turkey (Türkiye) |
| Sakarya University Medical Faculty Psychiatry Department | Sakarya | 54187 | Turkey (Türkiye) |
| MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association | Hlevakha | 8630 | Ukraine |
| Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3' | Kharkiv | 61068 | Ukraine |
| CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council | Kherson | 73488 | Ukraine |
| Kyiv Territorial Medical Incorporation 'Psychiatry' | Kyiv | 04080 | Ukraine |
| Municipal Institution 'Lviv Regional Clinical Psycho-Neurological Dispensary' | Lviv | 79017 | Ukraine |
| CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital' | Lviv | 79021 | Ukraine |
| CNCE Odesa regional psychiatric hospital #2 Odesa regional council | Oleksandrivka | 67513 | Ukraine |
| CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council' | Smila | 20708 | Ukraine |
| CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC' | Vinnytsia | 21005 | Ukraine |
| 37480362 | Derived | Najarian D, Turkoz I, Knight RK, Galderisi S, Lamaison HF, Zalitacz P, Aravind S, Richarz U. Long-Term Efficacy and Safety of Paliperidone 6-Month Formulation: An Open-Label 2-Year Extension of a 1-Year Double-Blind Study in Adult Participants With Schizophrenia. Int J Neuropsychopharmacol. 2023 Aug 29;26(8):537-544. doi: 10.1093/ijnp/pyad028. |
| 34791283 | Derived | Najarian D, Sanga P, Wang S, Lim P, Singh A, Robertson MJ, Cohen K, Schotte A, Milz R, Venkatasubramanian R, T'Jollyn H, Walling DP, Galderisi S, Gopal S. A Randomized, Double-Blind, Multicenter, Noninferiority Study Comparing Paliperidone Palmitate 6-Month Versus the 3-Month Long-Acting Injectable in Patients With Schizophrenia. Int J Neuropsychopharmacol. 2022 Mar 17;25(3):238-251. doi: 10.1093/ijnp/pyab071. |
| FG001 | Double-blind PP3M | Participants received 4 doses of PP3M (350 or 525 mg eq. IM injection for up to 12 months (1 dose every 3 month) during DB phase. |
| FG002 | Double-blind PP6M | Participants received 2 doses of PP6M (700 or 1000 mg eq. IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug. |
| FG003 | Follow-up (FU) Phase PP3M | Participants who have received at least 1 dose of PP3M (350 or 525 mg eq.) IM injection during double-blind phase but then have relapsed or have met other relevant conditions for withdrawal or discontinuation can participate in the follow-up phase PP3M (350 or 525 mg eq.) IM injection for up to 12 months for evaluating efficacy and safety. |
| FG004 | Follow-up Phase PP6M | Participants received PP6M (700 or 1000 mg eq.) IM injection for up to 12 months for evaluating efficacy and safety. |
| COMPLETED |
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| NOT COMPLETED |
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| Double-Blind Phase |
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| Follow-Up Phase |
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Not provided
| ID | Title | Description |
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| BG000 | Open-Label (OL) PP1M/PP3M | Participants previously treated with oral antipsychotics, or injectable risperidone, or a moderate or higher dose of paliperidone palmitate 1-month (PP1M) with previous initiation but without previous stabilization (where stabilization was defined as at least 3 months of injections with the last 2 doses being the same strength) received 1 to 5 intramuscular (IM) injections of PP1M 50 to 150 milligrams equivalent (mg eq.). Participants received single dose of IM injection of PP1M as 100 or 150 mg eq. or PP3M as 350 or 525 mg eq during the OL-maintenance phase. |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | Time to Relapse During the Double-Blind (DB) Phase | Time to relapse is time between participant randomization in DB Phase and first documentation of relapse event by end of Month 12 of DB phase. Relapse is defined as: a) Psychiatric hospitalization; b) Positive and Negative Syndrome Scale (PANSS) total score: Increase of 25 percentage (%), 10 point increase in PANSS for 2 analysis separated by 3-7 days if score was greater than (>) 40, less than or equal to (<=)40; c) Participants inflicted knowing self-injury/shown violent behavior leading to suicide, clinically significant injury to him/herself or other person/property; d) Participants had suicidal/homicidal ideation/violent behavior that was clinically significant as per investigator; e) PANSS items P1- delusions, P2- conceptual disorganization, P3-hallucinatory behavior, P6- suspiciousness/ persecution, P7-hostility, G8-uncooperativeness: score: greater than or equal to (>=)5, >=6 for 2 analysis separated by 3-7 days on any items if maximum score for PANSS: <=3 or 4, respectively. | DB Intent-to-Treat (ITT) analysis set included participants who were randomly assigned to paliperidone palmitate 6-month (PP6M) /paliperidone palmitate 3-month (PP3M) during DB Phase, received at least 1 dose of PP6M/PP3M. | Posted | Median | 95% Confidence Interval | Days | Up to 12 months of DB Phase |
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| Secondary | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score | The neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale, which provides a total score (sum of the scores for all 30 items) and scores for 3 subscales: the 7-item positive-symptom (P) subscale, the 7-item negative-symptom (N) subscale, and the 16-item general-psychopathology symptom (G) subscale. Each item is rated on a scale from 1 (absent) to 7 (extreme). The PANSS total score ranges from 30 (absent disease)-210 (more severe neuropsychiatric symptoms of schizophrenia). | DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline (DB) to 12 Months of DB Phase |
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| Secondary | Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score | CGI-S is defined as clinician-rated scale that assesses the severity of mental illness on a scale of 0 to 7. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to:1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill patients. A higher score implies a more severe condition. | DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline (DB) to 12 Months of DB Phase |
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| Secondary | Change From Baseline in the Personal and Social Performance (PSP) Scale Total Score | The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Each domain was assessed on a 6-point scale, from 1 (absent) to 6 (very severe) (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe). PSP total score was calculated as sum of all the domain scores and ranges from 1 to 100. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Higher score indicates better performance. | DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline (DB) to 12 Months of DB Phase |
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| Secondary | Percentage of Participants With Symptomatic Remission Based on PANSS Score During DB Phase | Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity. The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. | DB ITT included all participants who were randomly assigned to treatment group of either PP6M or PP3M, received at least 1 dose of PP6M/PP3M. | Posted | Number | Percentage of participants | Up to 12 months of DB Phase |
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| Secondary | Change From Baseline in the Satisfaction With Participants in Social Roles (SPSR) Score | The SPSR Short Form 8a is a participant-reported outcome used to assess the satisfaction with participation in social roles. The participants were asked to rate 8 items on 5-point Likert scale, with scores ranging from 8 to 40, where higher scores represents higher satisfaction. | DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline (DB) to 12 Months of DB Phase |
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| Secondary | Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score | TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions were calculated and used for analysis. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction. | DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline (DB) to 12 Months of DB Phase |
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| Secondary | Change From Baseline in the Simpson-Angus Rating Scale (SAS) Total Score | The SAS rates 10 items for general extrapyramidal symptoms (EPS) on a 5-point scale from 0 (normal) to 4 (extreme), including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head rotation, Glabellar tap, tremor, and salivation. The SAS total score is the average score (total sum of item scores divided by the number of items) and ranges between 0 and 4. Negative change in score indicates improvement. Higher scores denote more severe condition of EPS. | DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. | Posted | Median | Full Range | units on a scale | Baseline (DB) to 12 Months of DB Phase |
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| Secondary | Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score | BARS is used to rate observable, restless movements of drug induced akathisia and subjective awareness of restlessness and any distress associated with the akathisia. BARS consists of the following 4 items: objective assessment of akathisia symptoms, subjective assessment of the participants's awareness of inner restlessness, distress restlessness, and global clinical assessment of akathisia. First three items are rated on a 4-point scale ranging from 0 (no abnormal movements or absence of inner restlessness or no distress) to 3 (severe akathisia or awareness of intense compulsion to move most of the time or severe distress). The last item, the global clinical assessment of akathisia, is rated on a 6-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). | DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. | Posted | Count of Participants | Participants | Up to 12 Months of DB Phase |
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| Secondary | Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Total Score | AIMS is a 14-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 to 14 are yes/no questions regarding the global judgement and dental status of the participant. The total score is the sum of the scores for the 14 items and the possible total score ranges from 0 to 44. A higher total score is indicative of more severe dyskinetic movements. | DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. | Posted | Median | Full Range | units on a scale | Baseline (DB) to 12 Months of DB Phase |
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| Secondary | Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score | The C-SSRS is a questionnaire used for suicide risk assessment. Affirmative or negative responses are provided to items 1 to 5 for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods [not plan] without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and items 6 to 10 for suicide behavior (6. Preparatory acts or behavior, 7. Aborted attempt, 8. Interrupted attempt, 9. Actual attempt, 10. Completed suicide). Total score ranges from 1 to 10. Higher scores indicate more severe suicidal ideation. | DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'n' (number analyzed) included all evaluable participants who were analyzed for specified categories. | Posted | Count of Participants | Participants | Baseline and endpoint (12 Months of DB Phase) |
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| Secondary | Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase | Number of participants with treatment-emergent abnormal ECG values were reported. It includes heart rate (abnormally low refers to less than or equal to [<=] 50 beats per minute (bpm) , abnormally high refers greater than or equal to [>=] 100 bpm), pulse rate (PR) interval (abnormally high refers to >= 210 milliseconds [msec]), QRS interval (abnormally Low refers to <= 50, abnormally high refers to >= 120 msec) and QT interval (abnormally low refers to <= 200, abnormally high >= 500 msec). | Double-blind safety analysis set (DB safety) included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline (DB) to 12 Months of DB Phase |
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| Secondary | Change From Baseline in the Body Mass Index (BMI) During DB Phase | Change from baseline in BMI was reported. | DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | kilogram per meter square (kg/m^2) | Baseline (DB) to 12 Months of DB Phase |
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| Secondary | Change From Baseline in the Waist Circumference During DB Phase | Change from baseline in waist circumference was reported. | DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | centimeter (cm) | Baseline (DB) to 12 Months of DB Phase |
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| Secondary | Change From Baseline in the Body Weight During DB Phase | Change from baseline in body weight was reported. | DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | kilogram (kg) | Baseline (DB) to 12 Months of DB Phase |
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| Secondary | Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase | Change from baseline vital signs (pulse rate) were reported. This included supine pulse rate, standing pulse rate and supine-standing pulse rate. | DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline (DB) to 12 Months of DB Phase |
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| Secondary | Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase | Change from baseline in vital signs including SBP and DBP (supine/standing) were reported. | DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | millimetre of mercury (mmHg) | Baseline (DB) to 12 Months of DB Phase |
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| Secondary | Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase | The neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale, which provides a total score (sum of the scores for all 30 items) and Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology). | DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline (DB) to 12 Months of DB Phase |
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| Secondary | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase | Number of participants with clinically significant abnormal laboratory values in chemistry included alanine aminotransferase (Unit per Litre [U/L]), albumin (Gram per Litre [g/L]), alkaline phosphatase (U/L), aspartate aminotransferase (U/L), bicarbonate (millimoles per litre [mmol/L]), bilirubin (micromoles per litre [umol/L]), calcium (mmol/L), chloride (mmol/L), cholesterol (mmol/L), creatinine (umol/L), gamma glutamyl transferase (GGT) (U/L), glucose (mmol/L), high-density lipoproteins (HDL) cholesterol (mmol/L), low density lipoproteins (LDL) cholesterol (mmol/L), lactate dehydrogenase (U/L), phosphate (mmol/L), potassium (mmol/L), protein (mmol/L), sodium (mmol/L), triglycerides (mmol/L), urate (umol/L), urea nitrogen (mmol/L) were reported. Here, ABL signifies abnormally low and ABH signifies abnormally high levels. | Double-Blind safety analysis set (DB safety) included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. Here 'n' (number analyzed) included all evaluable participants who were analyzed for specified categories. | Posted | Count of Participants | Participants | Up to 12 Months of DB Phase |
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| Secondary | Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase | Number of participants with clinically significant abnormal laboratory values in hematology included hemoglobin (Hb), hematocrit (Hct), red blood cell (RBC) count, white blood cell (WBC) count with differential, platelets, hemoglobin A1c. Here, ABL signifies abnormally low and ABH signifies abnormally high levels. | Double-blind safety analysis set (DB safety) included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. Here 'n' (number analyzed) included all evaluable participants who were analyzed for specified categories. | Posted | Count of Participants | Participants | Up to 12 Months of DB Phase |
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Up to 2.5 Years
Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Open-Label (OL) PP1M/PP3M | Participants previously treated with oral antipsychotics, or injectable risperidone, or a moderate or higher dose of paliperidone palmitate 1-month (PP1M) with previous initiation but without previous stabilization (where stabilization was defined as at least 3 months of injections with the last 2 doses being the same strength) received 1 to 5 intramuscular (IM) injections of PP1M 50 to 150 milligrams equivalent (mg eq.). Participants received single dose of IM injection of PP1M as 100 or 150 mg eq. or PP3M as 350 or 525 mg eq during the OL-maintenance phase. | 1 | 838 | 23 | 838 | 127 | 838 |
| EG001 | Double-blind PP3M | Participants received 4 doses of PP3M (350 or 525 mg eq. IM injection for up to 12 months (1 dose every 3 month) during DB phase. | 2 | 224 | 15 | 224 | 52 | 224 |
| EG002 | Double-blind PP6M | Participants received 2 doses of PP6M (700 or 1000 mg eq. IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug. | 1 | 478 | 24 | 478 | 125 | 478 |
| EG003 | Follow-up (FU) Phase PP3M | Participants who have received at least 1 dose of PP3M (350 or 525 mg eq.) IM injection during double-blind phase but then have relapsed or have met other relevant conditions for withdrawal or discontinuation can participate in the follow-up phase PP3M (350 or 525 mg eq.) IM injection for up to 12 months for evaluating efficacy and safety. | 0 | 42 | 1 | 42 | 1 | 42 |
| EG004 | Follow-up Phase PP6M | Participants received PP6M (700 or 1000 mg eq.) IM injection for up to 12 months for evaluating efficacy and safety. | 0 | 109 | 6 | 109 | 5 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Death | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Sudden Death | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
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| Limb Injury | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
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| Radius Fracture | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Non-systematic Assessment |
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| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Brain Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | Non-systematic Assessment |
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| Chronic Lymphocytic Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | Non-systematic Assessment |
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| Nasal Sinus Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | Non-systematic Assessment |
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| Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.1 | Non-systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 22.1 | Non-systematic Assessment |
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| Acute Psychosis | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Adjustment Disorder with Mixed Anxiety and Depressed Mood | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Adjustment Disorder with Mixed Disturbance of Emotion and Conduct | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Alcohol Withdrawal Syndrome | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Behavioural Addiction | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Completed Suicide | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Hallucination, Auditory | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Mental Disorder | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Mixed Anxiety and Depressive Disorder | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Panic Disorder | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Psychotic Disorder | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Psychotic Symptom | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Suicidal Ideation | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Suicide Attempt | Psychiatric disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pelvi-Ureteric Obstruction | Renal and urinary disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Priapism | Reproductive system and breast disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Mammoplasty | Surgical and medical procedures | MedDRA Version 22.1 | Non-systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Peripheral Artery Occlusion | Vascular disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | General disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Weight Increased | Investigations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 22.1 | Non-systematic Assessment |
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The non-inferiority design was based on the principle of enrichment; that is, criteria of clinical stability were applied prior to entry into the Double-blind Phase. Hence, the ITT (DB) analysis set does not reflect the overall sample of participants who were initially enrolled in Study PSY3015 (ClinicalTrials.gov Identifier: NCT03345342) for treatment with PP3M/PP6M. Therefore, results may not reflect true efficacy for prevention of relapses in the overall population.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the Sponsor for review at least 60 days before submission for publication or presentation. Expedited reviews will be arranged for abstracts, poster presentations, or other materials. If requested by the Sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Compound Development Team Leader | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 26, 2020 | Sep 22, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Death |
|
| Initiated Prohibited Medication |
|
| Lost to Follow-up |
|
| Physician Decision |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Other |
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| Lost to Follow-up |
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| Physician Decision |
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| Withdrawal by Subject |
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| Other |
|
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| BRAZIL |
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| BULGARIA |
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| CZECH REPUBLIC |
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| FRANCE |
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| HONG KONG |
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| HUNGARY |
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| INDIA |
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| ITALY |
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| KOREA, REPUBLIC OF |
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| MALAYSIA |
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| MEXICO |
|
| POLAND |
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| RUSSIAN FEDERATION |
|
| SPAIN |
|
| TAIWAN |
|
| TURKEY |
|
| UKRAINE |
|
| UNITED STATES |
|
|
|
| Units | Counts |
|---|---|
| Participants |
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Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
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| Units |
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| Counts |
|---|
| Participants |
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| Participants |
|
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| OG001 |
| DB PP6M |
Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug. |
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