Et langtidsstudie i skizofreni
10. september 2026 opdateret af: Denovo Biopharma LLC
Langsigtet åbent sikkerhedsundersøgelse af Pomaglumetad Methionil hos patienter med skizofreni
Formålet med denne undersøgelse er at evaluere den langsigtede sikkerhed af pomaglumetad methionil hos deltagere med skizofreni.
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
The primary objective of this study was to evaluate the long-term safety of pomaglumetad methionil (LY2140023) in patients with schizophrenia by monitoring extrapyramidal symptoms (EPS), as evaluated by the Barnes Akathisia Scale (BAS), the Simpson-Angus Scale (SAS), and the Abnormal Involuntary Movement Scale (AIMS); weight; prolactin; and the following metabolic parameters: fasting glucose, total cholesterol, low-density lipoprotein cholesterol (LDL), high-density lipoprotein (HDL) cholesterol, and total triglycerides.
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
129
Fase
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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Salvador, Brasilien, 40301500
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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São Paulo, Brasilien, 22270-060
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California
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Cerritos, California, Forenede Stater, 90703
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Escondido, California, Forenede Stater, 92025
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Garden Grove, California, Forenede Stater, 92845
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Long Beach, California, Forenede Stater, 90813
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San Diego, California, Forenede Stater, 92123
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Sherman Oaks, California, Forenede Stater, 91403
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Torrance, California, Forenede Stater, 90502
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20016
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Florida
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Coral Gables, Florida, Forenede Stater, 33145
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Lauderhill, Florida, Forenede Stater, 33319
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Maitland, Florida, Forenede Stater, 32751
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North Miami, Florida, Forenede Stater, 33161
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Oakland Park, Florida, Forenede Stater, 33334
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Sanford, Florida, Forenede Stater, 32771
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Illinois
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Chicago, Illinois, Forenede Stater, 60640
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46260
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Louisiana
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Lake Charles, Louisiana, Forenede Stater, 70629
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Mississippi
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Flowood, Mississippi, Forenede Stater, 39232
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Missouri
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Creve Coeur, Missouri, Forenede Stater, 63141
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New Jersey
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Marlton, New Jersey, Forenede Stater, 08053
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Princeton, New Jersey, Forenede Stater, 08540
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New York
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Brooklyn, New York, Forenede Stater, 11235
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Cedarhurst, New York, Forenede Stater, 11516
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Fresh Meadows, New York, Forenede Stater, 11366
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Rochester, New York, Forenede Stater, 14615
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Staten Island, New York, Forenede Stater, 10312
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28211
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Ohio
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Beachwood, Ohio, Forenede Stater, 44122
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73103
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oregon
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Eugene, Oregon, Forenede Stater, 97401
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Philadelphia, Pennsylvania, Forenede Stater, 19139
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Austin, Texas, Forenede Stater, 78754
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DeSoto, Texas, Forenede Stater, 75115
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Wharton, Texas, Forenede Stater, 77488
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Virginia
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Richmond, Virginia, Forenede Stater, 23230
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Limoges, Frankrig, 87025
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Chaïdári, Grækenland, 12462
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Bialystok, Polen, 15-879
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Gdynia, Polen, 81-361
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San Juan, Puerto Rico, 00926
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Bucharest, Rumænien, 041914
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Madrid, Spanien, 28031
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vic, Spanien, 08500
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Luleå, Sverige, SE 972 35
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Malmö, Sverige, 21153
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Dresden, Tyskland, 01307
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Oranienburg, Tyskland, 16515
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Vienna, Østrig, 1010
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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
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Deltagerne er klinisk diagnosticeret med skizofreni
- Kvindelige deltagere i den fødedygtige alder skal teste negativ for graviditet ved studiestart og acceptere at bruge en enkelt, effektiv, medicinsk acceptabel præventionsmetode
- Nye deltagere skal kræve påbegyndelse af eller ændring af nuværende antipsykotisk behandling, som indikeret af deres nuværende kliniske psykiatriske status og/eller behandlingstolerabilitet som ambulant. Kriteriet gælder ikke for deltagere, der ruller over fra en feeder-undersøgelse (NCT01328093 og NCT01452919)
- Deltagerne skal betragtes som pålidelige og have et niveau af forståelse, der er tilstrækkeligt til at udføre alle test og undersøgelser, der kræves af protokollen, og være villige til at udføre alle undersøgelsesprocedurer
- Deltagerne skal være i stand til at forstå undersøgelsens karakter og have givet deres eget informerede samtykke
Ekskluderingskriterier:
- Er i øjeblikket tilmeldt eller afbrudt inden for de sidste 60 dage fra et klinisk forsøg, der involverer et forsøgsprodukt (IP) eller ikke-godkendt brug af et lægemiddel eller en enhed, eller samtidig tilmeldt enhver anden form for medicinsk forskning, der vurderes ikke at være videnskabeligt eller medicinsk kompatibel med denne undersøgelse, bortset fra deltagere, der ruller over fra et feeder-studie (NCT01328093 og NCT01452919), som vil have gennemført et klinisk forsøg med pomaglumetad methionil
- Har andre aktuelle psykiatriske diagnoser ud over skizofreni
- Har tidligere gennemført eller trukket sig fra dette studie eller ethvert andet studie, der undersøger pomaglumetad methionil eller et hvilket som helst forgængermolekyle med glutamaterg aktivitet, undtagen deltagere, der ruller over fra et feeder-studie (NCT01328093 og NCT01452919), som vil have gennemført et klinisk forsøg med pothionillumet meth.
- Deltagere, der efter investigatorens mening har modtaget et tilstrækkeligt behandlingsforsøg med clozapin i doser på over 200 mg dagligt inden for 12 måneder før undersøgelsens start, eller som overhovedet har modtaget clozapin i løbet af måneden før undersøgelsens start
- Deltagere, der har en historie med utilstrækkelig klinisk respons på antipsykotisk behandling for skizofreni
- Deltagere, der af en eller anden grund anses for at være til fare for sig selv, eller som aktivt udviser selvmordsadfærd
- Kvindelige deltagere, der er gravide, ammer eller har til hensigt at blive gravide inden for 30 dage efter at have afsluttet undersøgelsen
- Har kendt ukorrigeret snævervinklet glaukom
- Deltagere med aktuelle eller tidligere anfaldssygdomme, leukopeni, ukontrolleret diabetes, visse leversygdomme, nyreinsufficiens, ukontrolleret skjoldbruskkirteltilstand eller andre alvorlige eller ustabile sygdomme
- Deltagere, der har haft elektrokonvulsiv terapi (ECT) inden for 3 måneder efter studiestart, eller som vil have ECT på et hvilket som helst tidspunkt under undersøgelsen
- Deltagere med kendt sygehistorie med positiv status for humant immundefektvirus (HIV).
- Deltagere, der tester positive for (1) Hepatitis C-virus-antistof eller (2) Hepatitis B-overfladeantigen (HBsAg) med eller uden positivt Hepatitis B-kerne-total-antistof
- Deltagere med et korrigeret QT-interval (Bazett's; QTcB) >450 msek (mand) eller >470 msek (kvinde) ved undersøgelsens start
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Antal våben
1
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Eksperimentel: Pomaglumetad methionil
Pomaglumetad methionil will be administered orally.
Participants entering the study will be flexibly dosed between 20 milligrams (mg), 40 mg, or 80 mg twice daily.
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Indgives oralt
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Kategorisk ændring fra baseline op til 5 år i Barnes Akathisia Scale (BAS)
Tidsramme: Baseline, op til 5 år
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Baseline, op til 5 år
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Kategorisk ændring fra baseline op til 5 år i Simpson-Angus Scale (SAS)
Tidsramme: Baseline, op til 5 år
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Baseline, op til 5 år
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Kategorisk ændring fra baseline op til 5 år i Abnormal Involuntary Movement Scale (AIMS)
Tidsramme: Baseline, op til 5 år
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Baseline, op til 5 år
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Andel af deltagere med klinisk signifikant vægtændring fra baseline op til 5 år
Tidsramme: Baseline op til 5 år
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Baseline op til 5 år
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Kategorisk ændring fra baseline op til 5 år i prolaktinniveau
Tidsramme: Baseline, op til 5 år
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Baseline, op til 5 år
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Kategorisk ændring fra baseline op til 5 år i fastende glukose og lipider
Tidsramme: Baseline, op til 5 år
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Baseline, op til 5 år
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Tid til manglende effekt
Tidsramme: Baseline op til 5 år
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Baseline op til 5 år
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Antal deltagere med selvmordsadfærd og -forestillinger målt ved Columbia Suicide Severity Rating Scale (CSSRS)
Tidsramme: Baseline op til 5 år
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Baseline op til 5 år
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Ændring fra baseline op til 5 år i Clinical Global Impressions-Severity (CGI-S)
Tidsramme: Baseline, op til 5 år
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Baseline, op til 5 år
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Ændring fra baseline op til 5 år i Brief Psychiatric Rater Scale (BPRS)
Tidsramme: Baseline, op til 5 år
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Baseline, op til 5 år
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
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
Studiestart
1. december 2011
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
1. oktober 2012
Studieafslutning (Faktiske)
Studieafslutning
1. oktober 2012
Datoer for studieregistrering
Først indsendt
Først indsendt
30. november 2011
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
6. december 2011
Først opslået (Anslået)
Først opslået
7. december 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
14. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. september 2026
Sidst verificeret
Sidst verificeret
1. oktober 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 12666
- H8Y-MC-HBBV (Anden identifikator: Eli Lilly and Company)
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 .