An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
25. juli 2017 opdateret af: Alkermes, Inc.
A Phase 3, Multicenter Extension of Study ALK9072-003EXT to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia
This is an extension of a previous study (ALK9072-003EXT).
The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
291
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Burgas, Bulgarien
- Alkermes Investigational Site
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Novi Iskar, Bulgarien
- Alkermes Investigational Site
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Pazardzhik, Bulgarien
- Alkermes Investigational Site
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Plovdiv, Bulgarien
- Alkermes Investigational Site
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Sofia, Bulgarien
- Alkermes Investigational Site
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Targovishte, Bulgarien
- Alkermes Investigational Site
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Veliko Tarnovo, Bulgarien
- Alkermes Investigational Site
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Vratsa, Bulgarien
- Alkermes Investigational Site
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Lipetsk, Den Russiske Føderation
- Alkermes Investigational Site
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Moscow, Den Russiske Føderation
- Alkermes Investigational Site
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Rostov-on-Don, Den Russiske Føderation
- Alkermes Investigational Site
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Samara, Den Russiske Føderation
- Roshchino township
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Saratov, Den Russiske Føderation
- Roshchino township
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St. Petersburg, Den Russiske Føderation
- Alkermes Investigational Site
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Stavropol, Den Russiske Føderation
- Alkermes Investigational Site
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Talagi, Den Russiske Føderation
- Alkermes Investigational Site
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Yaroslavl, Den Russiske Føderation
- Alkermes Investigational Site
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Vyborgskiy
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Roshchino, Vyborgskiy, Den Russiske Føderation
- Alkermes Investigational Site
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Cebu City, Filippinerne
- Alkermes Investigational Site
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Iloilo City, Filippinerne
- Alkermes Investigational Site
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Mandaluyong City, Filippinerne
- Alkermes Investigational Site
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Manila, Filippinerne
- Alkermes Investigational Site
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Bataan
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Mariveles, Bataan, Filippinerne
- Alkermes Investigational Site
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72201
- Alkermes Investigational Site
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Little Rock, Arkansas, Forenede Stater, 72211
- Alkermes Investigational Site
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California
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Garden Grove, California, Forenede Stater, 92845
- Alkermes Investigational Site
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Oakland, California, Forenede Stater, 94612
- Alkermes Investigational Site
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Oceanside, California, Forenede Stater, 92056
- Alkermes Investigational Site
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Orange, California, Forenede Stater, 92868
- Alkermes Investigational Site
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District of Columbia
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Washington, D.C., District of Columbia, Forenede Stater, 20016
- Alkermes Investigational Site
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Florida
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Fort Lauderdale, Florida, Forenede Stater, 33308
- Alkermes Investigational Site
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Leesburg, Florida, Forenede Stater, 34748
- Alkermes Investigational Site
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Georgia
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Atlanta, Georgia, Forenede Stater, 30308
- Alkermes Investigational Site
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Illinois
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Chicago, Illinois, Forenede Stater, 60640
- Alkermes Investigational Site
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Chicago, Illinois, Forenede Stater, 60611
- Alkermes Investigational Site
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Hoffman Estates, Illinois, Forenede Stater, 60169
- Alkermes Investigational Site
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Louisiana
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Shreveport, Louisiana, Forenede Stater, 71101
- Alkermes Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73116
- Alkermes Investigational Site
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Texas
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Dallas, Texas, Forenede Stater, 75231
- Alkermes Investigational Site
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Dallas, Texas, Forenede Stater, 75243
- Alkermes Investigational Site
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Jeollanam-do, Korea, Republikken
- Alkermes Investigational Site
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Cheras, Malaysia
- Alkermes Investigational Site
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Johor Bahru, Malaysia
- Alkermes Investigational Site
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Kuala Lampur, Malaysia
- Alkermes Investigational Site
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Kuching, Malaysia
- Alkermes Investigational Site
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Bucharest, Rumænien
- Alkermes Investigational Site
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Oradea, Rumænien
- Alkermes Investigational Site
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Targu Mures, Rumænien
- Alkermes Investigational Site
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Chernigiv, Ukraine
- Alkermes Investigational Site
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Donetsk, Ukraine
- Alkermes Investigational Site
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Kharkiv, Ukraine
- Alkermes Investigational Site
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Kherson, Ukraine
- Alkermes Investigational Site
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Kyiv, Ukraine
- Alkermes Investigational Site
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Lviv, Ukraine
- Alkermes Investigational Site
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Poltava, Ukraine
- Alkermes Investigational Site
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Ternopil, Ukraine
- Alkermes Investigational Site
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Vinnytsia, Ukraine, 61068
- Roshchino township
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Completed the treatment period of Study ALK9072-003EXT
- Continues to require chronic treatment with an antipsychotic medication
- Continues to reside in a stable living situation
- Continues to have an identified reliable informant
Exclusion Criteria:
- Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding during participation in Study ALK9072-003EXT that was clinically relevant and related to study drug
- Missed more than 1 scheduled study visit during participation in the preceding Study ALK9072-003EXT
- Has a significant or unstable medical condition that would preclude safe completion of the current study
- Subject is pregnant or breastfeeding
- Subject expects to be incarcerated, or has pending legal action which may impact compliance with study participation or procedures
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: ALKS 9072, Low Dose
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Intramuscular injection, given monthly
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Eksperimentel: ALKS 9072, High Dose
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Intramuscular injection, given monthly
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
Tidsramme: Up to 12 months
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This measure includes all incidences, including those that occurred >5%.
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Up to 12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time
Tidsramme: Up to 12 months
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This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme.
Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale).
Change is calculated between the baseline visit and the subject's last visit in the treatment period.
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Up to 12 months
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Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time
Tidsramme: Up to 12 months
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The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time.
Results indicate participants evaluated at one of the following categories: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients".
Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data.
Change is calculated between the baseline visit and the subject's last visit in the treatment period.
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Up to 12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Robert Risinger, MD, Alkermes, Inc.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- McEvoy JP, Weiden PJ, Lysaker PH, Sun X, O'Sullivan AK. Long-term effect of aripiprazole lauroxil on health-related quality of life in patients with schizophrenia. BMC Psychiatry. 2021 Mar 24;21(1):164. doi: 10.1186/s12888-021-03124-2.
- Lauriello J, Claxton A, Du Y, Weiden PJ. Beyond 52-Week Long-Term Safety: Long-Term Outcomes of Aripiprazole Lauroxil for Patients With Schizophrenia Continuing in an Extension Study. J Clin Psychiatry. 2020 Aug 18;81(5):19m12835. doi: 10.4088/JCP.19m12835.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2013
Primær færdiggørelse (Faktiske)
1. juni 2016
Studieafslutning (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først indsendt
5. juli 2013
Først indsendt, der opfyldte QC-kriterier
9. juli 2013
Først opslået (Skøn)
10. juli 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juli 2017
Sidst verificeret
1. juli 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ALK9072-003EXT2
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .