Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
Sponsor
ACADIA Pharmaceuticals Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03121586
Collaborator
(none)
500
148
1
85.9
3.4
0
Study Details
Study Description
Brief Summary
To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
Actual Study Start Date
:
Jan 1, 2017
Anticipated Primary Completion Date
:
Mar 1, 2024
Anticipated Study Completion Date
:
Mar 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Drug - Pimavanserin Pimavanserin 34 mg, 20 mg, or 10 mg, + background antipsychotic, taken once daily by mouth |
Drug: Pimavanserin
Pimavanserin 10 mg, tablet, taken as one 10 mg tablets, once daily by mouth, OR Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth, OR Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth
|
Outcome Measures
Primary Outcome Measures
- Evaluate the long-term safety and tolerability of pimavanserin (e.g., Summary of Treatment-Emergent Adverse Events [Safety and Tolerability]) [52 weeks]
Evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patient is able to understand and provide signed informed consent
-
Has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) considered reliable by the Investigator in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures and who is also able to provide input helpful for completing study rating scale
-
Is completing the Week 6 visit in Study ACP-103-034 or the Week 26 visit in Study ACP-103-038 or 064 while continuing to take his/her assigned dose of blinded study drug and may, in the Investigator's opinion, benefit from continued adjunctive treatment with pimavanserin to a antipsychotic
-
If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use two clinically acceptable methods of contraception
-
The main background antipsychotic with which the subject is being treated must continue to be on one of the antipsychotics listed below:
-
Aripiprazole
-
Aripiprazole long-acting injectables:
-
Abilify Maintena®
-
Aristada®
-
Asenapine
-
Risperidone
-
Risperidone long-acting injection
-
Olanzapine
-
Paliperidone extended release (ER) (≤9 mg)
-
Paliperidone palmitate
-
Invega Sustenna® (≤156 mg)
-
Invega Trinza® (≤546 mg)
-
Trevicta® (≤350 mg)
-
Xeplion® (≤100 mg)
-
Lurasidone
-
Cariprazine
-
Brexpiprazole
-
Asenapine
Exclusion Criteria:
-
Patient is judged by the Investigator or the Medical Monitor to be inappropriate for the study (e.g., significantly noncompliant in Studies ACP-103-034, -038, or -064)
-
A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse
-
Subjects from Studies 034 and 038 with a result indicating the presence of marijuana are permitted, if allowed by medical regulations, if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation
-
Subjects from Study 064 with a result indicating the presence of marijuana are not permitted in the study
-
Is taking a medication or drug or other substance that is prohibited according to this protocol
-
Known family or personal history or symptoms of long QT syndrome or risk factors for torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval
-
Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the study.
Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alea Research Institute | Phoenix | Arizona | United States | 85012 |
| 2 | Woodland International Research Group, LLC | Little Rock | Arkansas | United States | 72211 |
| 3 | Woodland Research Northwest, LLC | Rogers | Arkansas | United States | 72758 |
| 4 | CITrials - Bellflower | Bellflower | California | United States | 90706 |
| 5 | ProScience Research Group | Culver City | California | United States | 90230 |
| 6 | Synergy San Diego | Lemon Grove | California | United States | 91945 |
| 7 | Long Beach VA Healthcare System | Long Beach | California | United States | 90822 |
| 8 | Synergy San Diego | National City | California | United States | 91950 |
| 9 | Artemis Institute for Clinical Research | San Diego | California | United States | 92103 |
| 10 | Sharp Mesa Vista Hospital | San Diego | California | United States | 92123 |
| 11 | CITrials | Santa Ana | California | United States | 92705 |
| 12 | Collaborative Nueroscience Network, LLC | Torrance | California | United States | 90502 |
| 13 | Flagship Norwalk, LLC | Norwalk | Connecticut | United States | 90650 |
| 14 | Galiz Research | Hialeah | Florida | United States | 33016 |
| 15 | Innovative Clinical Research, Inc. | Lauderhill | Florida | United States | 33319 |
| 16 | Premier Clinical Research Institute, Inc. | Miami | Florida | United States | 33122 |
| 17 | Miller School of Medicine University of Miami | Miami | Florida | United States | 33136 |
| 18 | Meridien Research | Orlando | Florida | United States | 32810 |
| 19 | Stedman Clinical Trials | Tampa | Florida | United States | 33613 |
| 20 | Synexus Clinical Research, Inc. | Atlanta | Georgia | United States | 30328 |
| 21 | Atlanta Center for Medical Research | Atlanta | Georgia | United States | 30331 |
| 22 | iResearch Atlanta LLC | Decatur | Georgia | United States | 30030 |
| 23 | Northwest Behavioral Research Center | Marietta | Georgia | United States | 30060 |
| 24 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 25 | American Medical Research | Chicago | Illinois | United States | 60612 |
| 26 | Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois | United States | 60169 |
| 27 | Department of Psychiatry and Behavioral Sciences KU School of Medicine-Wichita | Wichita | Kansas | United States | 67214 |
| 28 | Lake Charles Clinical Trials | Lake Charles | Louisiana | United States | 70629 |
| 29 | Altea Research Institute | Las Vegas | Nevada | United States | 89102 |
| 30 | Hassman Research Institute | Berlin | New Jersey | United States | 08009 |
| 31 | Albuquerque Neuroscience Inc. | Albuquerque | New Mexico | United States | 87109 |
| 32 | Neurobehavioral Research, Inc. | Cedarhurst | New York | United States | 11516 |
| 33 | Synexus Clinical Research, Inc. | Jamaica | New York | United States | 11432 |
| 34 | Finger Lakes Clinical Research | Rochester | New York | United States | 14618 |
| 35 | New Hope Clinical Research | Charlotte | North Carolina | United States | 28211 |
| 36 | Carolina Behavioral Care | Durham | North Carolina | United States | 27704 |
| 37 | Midwest Clinical Research Center | Dayton | Ohio | United States | 45417 |
| 38 | Cutting Edge Research Group | Oklahoma City | Oklahoma | United States | 73116 |
| 39 | Suburban Research Associates | Downingtown | Pennsylvania | United States | 19335 |
| 40 | University Hills Clinical Research | Irving | Texas | United States | 75062 |
| 41 | Pillar Clinical Research, LLC | Richardson | Texas | United States | 75080 |
| 42 | Psychiatric and Behavioral Solutions LLC | Salt Lake City | Utah | United States | 84105 |
| 43 | Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD | Burgas | Bulgaria | 8000 | |
| 44 | State Psychiatric Hospital - Kardzhali, EOOD | Kardzhali | Bulgaria | 6600 | |
| 45 | State Psychiatric Hospital - Lovech | Lovech | Bulgaria | 5500 | |
| 46 | State Psychiatric Hospital - Pazardzhik AD | Pazardzhik | Bulgaria | 4400 | |
| 47 | UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Physchiatry | Plovdiv | Bulgaria | 4000 | |
| 48 | Medical Center Mentalcare OOD | Plovdiv | Bulgaria | 4004 | |
| 49 | Medical Centre "Sveti Naum" | Sofia | Bulgaria | 1113 | |
| 50 | MHC - Sofia, EOOD | Sofia | Bulgaria | 1202 | |
| 51 | DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD | Sofia | Bulgaria | 1408 | |
| 52 | Military Medical Academy, Multiprofile Hospital for Actie Treatment - Sofia | Sofia | Bulgaria | 1431 | |
| 53 | UMHAT "Alexandrovska" EAD | Sofia | Bulgaria | 1431 | |
| 54 | Medical Center Hera EOOD | Sofia | Bulgaria | 1510 | |
| 55 | Medical Center Intermedica, OOD | Sofia | Bulgaria | 1680 | |
| 56 | MHAT-Targovishte, AD | Targovishte | Bulgaria | 7700 | |
| 57 | State Psychiatric Hospital - Tserova Koria | Tserova Koria | Bulgaria | 5047 | |
| 58 | DCC "Mladost M" - Varna, OOD | Varna | Bulgaria | 9020 | |
| 59 | Mental Health Center - Veliko Tarnovo EOOD | Veliko Tarnovo | Bulgaria | 5000 | |
| 60 | Mental Health Center-Vratsa EOOD | Vratsa | Bulgaria | 3000 | |
| 61 | Dr. Alexander McIntyre Inc. | Penticton | British Columbia | Canada | V2A 4M4 |
| 62 | Chatham-Kent Clinical Trials Research Ctr | Chatham | Ontario | Canada | N7L1C1 |
| 63 | Centre for Addiction and Mental Health | Toronto | Ontario | Canada | M6J 1H4 |
| 64 | McGill University Health Ctr Allan Memorial Int. | Montréal | Quebec | Canada | H3A 1A1 |
| 65 | NeuropsychiatrieHK s.r.o. | Hradec Králové | Czechia | 50341 | |
| 66 | A-SHINE s.r.o. | Plzen | Czechia | 31200 | |
| 67 | CLINTRIAL s.r.o. | Praha 10 | Czechia | 10000 | |
| 68 | MUDr. Tibor Miklos | Praha 10 | Czechia | 10600 | |
| 69 | MEDICAL SERVICES PRAGUE s.r.o. | Praha 6 | Czechia | 16000 | |
| 70 | Psychiatrie Ricany s.r.o. | Říčany | Czechia | 25101 | |
| 71 | Dr. Máthé és Társa Bt. | Kalocsa | Bács-Kiskun Megye | Hungary | 6300 |
| 72 | ÓBudai Egészségűgyi Centrum Kft | Budapest | Pest Megye | Hungary | 1036 |
| 73 | Semmelweis Egyetem | Budapest | Pest Megye | Hungary | 1083 |
| 74 | Jozsefvarosi Szent Kozma Egeszsegugyi Kozpont | Budapest | Hungary | 1084 | |
| 75 | Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet | Budapest | Hungary | 1135 | |
| 76 | Debreceni Egyetem | Debrecen | Hungary | 4032 | |
| 77 | Békés Megyei Központi Kórház/Pszichiátria osztály | Gyula | Hungary | 5700 | |
| 78 | PsychoTech Kft. | Pécs | Hungary | 7633 | |
| 79 | Neuromeda, JSC | Kaunas | Lithuania | 50185 | |
| 80 | Romuvos klinika, UAB | Kaunas | Lithuania | LT-44279 | |
| 81 | Kaunas City Outpatient Clinic, Public Institution | Kaunas | Lithuania | LT-48259 | |
| 82 | Silutes Mental Health and Psychotherapy Center, JSC | Silute | Lithuania | 99142 | |
| 83 | Zirmunai Mental Health Center, Public Institution | Vilnius | Lithuania | 09112 | |
| 84 | Antakalnis Psychiatric Consultation Center, Public Institution | Vilnius | Lithuania | 10204 | |
| 85 | Podlaskie Centrum Psychogeriatrii | Białystok | Poland | 15-756 | |
| 86 | Przychodnia Srodmiescie Sp. z o. o. | Bydgoszcz | Poland | 85-080 | |
| 87 | Centrum Badan Klinicznych P.I. House Sp. z o.o. | Gdańsk | Poland | 80-546 | |
| 88 | Care Clinic centrum Medyczne | Katowice | Poland | 40-568 | |
| 89 | Centrum Medyczne "Luxmed" Sp. z o.o. | Lublin | Poland | 20-080 | |
| 90 | Specjalistyczna Praktyka Lekarska Marek Domański | Lublin | Poland | 20-582 | |
| 91 | NZOZ Syntonia | Pruszcz Gdański | Poland | 83-000 | |
| 92 | Ośr. Badań Klin. CLINSANTE S.C. | Torun | Poland | 87-100 | |
| 93 | GUZ Lipetsk Regional psychoneurological Hospital #1 | Plekhanovo | Lipetsk Region | Russian Federation | 399313 |
| 94 | State Budget Healthcare Institution of Stavropol Region (Regional Specialized Psychiatric Hospital #2) | Tonnel'nyy | Stavropol Region | Russian Federation | 357034 |
| 95 | State Budget Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Psychiatric Hospital" | Arkhangel'sk | Russian Federation | 163530 | |
| 96 | Sverdlov Regional Psychiatric Clinical Hospital | Ekaterinburg | Russian Federation | 620030 | |
| 97 | State municipal healthcare Institution "Leningrad region psychoneurological center" | Leningrad | Russian Federation | 188820 | |
| 98 | Federal State Budgetary Research Institution "Mental Health Science Center" | Moscow | Russian Federation | 115522 | |
| 99 | Saint-Petersburg State Healthcare Institution "Saint Nicolas Wonderworker Psychiatric Hospital" | Saint Petersburg | Russian Federation | 190121 | |
| 100 | "Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev" | Saint Petersburg | Russian Federation | 192019 | |
| 101 | FSBI "National Medical Scientifi Center of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH | Saint Petersburg | Russian Federation | 192019 | |
| 102 | Saint-Petersburg Scientific Research Psychoneurological Institute N.A. V.M. Bekhterev | Saint Petersburg | Russian Federation | 192019 | |
| 103 | V. M. Bekhterev National Research Medical Center For Psychiatry and Neurology | Saint Petersburg | Russian Federation | 192019 | |
| 104 | Saint-Petersburg State Budget Healthcare Institution "Psychoneurological Center #5" | Saint Petersburg | Russian Federation | 195112 | |
| 105 | Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 n.a. I.I. Skvortsov-Stepanov" | Saint Petersburg | Russian Federation | 197341 | |
| 106 | Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 n.a.I.I. Skvortsov-Stepanov | Saint Petersburg | Russian Federation | 197341 | |
| 107 | SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-Stepanov | Saint Petersburg | Russian Federation | 197341 | |
| 108 | State Budget Healthcare Institution "Samara Psychiatric Hospital" | Saint Petersburg | Russian Federation | 443016 | |
| 109 | St. Petersburg SHI "Psychoneurological Dispensary #10" | Saint-Petersburg | Russian Federation | 190121 | |
| 110 | Saint Petersburg State Budget Healthcare Institution "City Psychiatric Hospital No. 6 (Inpatient Department with Treatment Center)" | Saint-Petersburg | Russian Federation | 193167 | |
| 111 | FSBEI HE "Smolensk State Medical University" of the MoH of the RF | Smolensk | Russian Federation | 214019 | |
| 112 | "Podderzhka" Research and Educational Center of Psychotherapy Limited Liability Company | Stavropol' | Russian Federation | 355000 | |
| 113 | OOO "Lion-Med" | Voronezh | Russian Federation | 394024 | |
| 114 | State Budget Healthcare Institution of Yaroslavl Region "Yaroslavl Region Clinical Psychiatric Hospital" | Yaroslavl | Russian Federation | 150003 | |
| 115 | Clinical center of Serbia | Belgrade | Serbia | 11 000 | |
| 116 | Clinic for Psychiatric Diseases "Dr Laza Lazarevic" | Belgrade | Serbia | 11000 | |
| 117 | Clinical Hospital Center "Dr. Dragisa Misovic-Dedinje", Clinic of Psychiatry | Belgrade | Serbia | 11000 | |
| 118 | General Hospital Euromedik | Belgrade | Serbia | 11000 | |
| 119 | Military Medical Academy Clinic of Psychiatry | Belgrade | Serbia | 11000 | |
| 120 | Institute of Mental Health | Belgrad | Serbia | 11000 | |
| 121 | Special Hospital for Psychiatric Diseases "Kovin" | Kovin | Serbia | 26220 | |
| 122 | Special Neuropsychiatric Hospital Kovin | Kovin | Serbia | 26220 | |
| 123 | Clinical Center Kragujevac, Clinic of Psychiatry | Kragujevac | Serbia | 34 000 | |
| 124 | Clinical Center Kragujevac | Kragujevac | Serbia | 34 000 | |
| 125 | Clinical Center Nis, Clinic of Mental Health | Nis | Serbia | 18 000 | |
| 126 | FIDMAG Germanes Hospitalaries | Barcelona | Spain | 08830 | |
| 127 | Hospital General Universitario Gregorio Marañon Instituto Provincial de Psiquiatria | Madrid | Spain | 28007 | |
| 128 | CSM La Corredoria | Oviedo | Spain | 33011 | |
| 129 | Centro de Salud Parquesol, 2ª planta - Servicio de Psiquiatria | Valladolid | Spain | 47016 | |
| 130 | Hospital Provincial de Zamora | Zamora | Spain | 49021 | |
| 131 | Communal Establishment "Odesa Regional Psychiatric Hospital #2" | Odessa | Oblast | Ukraine | 67513 |
| 132 | Communal Establishment "I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital" | Dnipro | Ukraine | 49005 | |
| 133 | CI of Kyiv RC Regional Psychiatric-Narcological Medical Association, Depart #10 (male), Dept #2 (female) | Hlevakha | Ukraine | 08631 | |
| 134 | SI "Institute of Neurology, Psychiatry and Narcology of National Academy of Medical Sciences of Ukraine" | Kharkiv | Ukraine | 61068 | |
| 135 | SI Institute of Neurology,Psychiatry&Narcology of NAMSU | Kharkiv | Ukraine | 61068 | |
| 136 | State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine", Department of Urgent Psychiatry and Narcology | Kharkiv | Ukraine | 61068 | |
| 137 | CI Kherson Regional Psychiatric Hospital of Kherson RC | Kherson | Ukraine | 73488 | |
| 138 | Main Military Clinical Hospital of MDU | Kyiv | Ukraine | 01133 | |
| 139 | Kyiv City Psychoneurological Hospital #2 Kyiv City Psychoneurological Hospital #2 Consultative Department | Kyiv | Ukraine | 02192 | |
| 140 | Kyiv Regional Medical Incorporation Psychiatry Center of Novel Treatment and Rehabilitation of Psychotic Disorders, Department #29, Department #30 | Kyiv | Ukraine | 04080 | |
| 141 | Ukrainian Scientific Research Institute of Social and Forensic Psychiatry and Narcology of Ministry of Healthcare of Ukraine | Kyiv | Ukraine | 04080 | |
| 142 | Kyiv City Psychoneurological Hospital #3, General Psychiatry Department No. 2 | Kyiv | Ukraine | 08631 | |
| 143 | CI of LRC Lviv Regional Psychoneurology Dispensary | Lviv | Ukraine | 79017 | |
| 144 | CI Lviv Regional Clinical Psychiatric Hospital Dept #20 | Lviv | Ukraine | 79021 | |
| 145 | CI Odesa Regional Medical Centre of Mental Health | Odesa | Ukraine | 65014 | |
| 146 | Poltava Regional Clinical Psychiatric Hospital n.a. O.F. Maltsev | Poltava | Ukraine | 36013 | |
| 147 | CI Cherkasy Regional Psychiatric Hospital of ChRC Female Dept #11, Male Dept #12 | Smila | Ukraine | 20708 | |
| 148 | Communal Establishment "Acad. O.I. Iushchenko Vinnytsia Regional Psychoneurologic Hospital" | Vinnytsia | Ukraine | 21005 |
Sponsors and Collaborators
- ACADIA Pharmaceuticals Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT03121586
Other Study ID Numbers:
- ACP-103-035
- 2016-003435-38
First Posted:
Apr 20, 2017
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: