Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder
26. februar 2014 oppdatert av: Bial - Portela C S.A.
Extension Study to Investigate the Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate (BIA 2-093) in the Recurrence Prevention of Bipolar I Disorder
This was an extension study consisting of 2 parts.
In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks.
Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily.
Patients stable in remission continued double-blind therapy until approximately 6 months after the last patient entered Part II.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
The occurrence of a new manic/depressive episode was considered a treatment failure, and the patient was discontinued from the study.
At the end of Part II, 6 months after last patient enrolled and after no longer than approximately 15 months, if patients were still in remission and the investigational product was well-tolerated, patients had the option to enter long-term open-label treatment at the same dosage as used in Part II until a new episode occurred, until marketing was authorized, or until clinical development of BIA 2-093 in the recurrence prevention indication was discontinued.
If patients did not enter long-term treatment, an established recurrence prevention medication was prescribed, and BIA 2-093 was tapered off (patients assigned to 1800 mg had the daily dose decreased to 900 mg for 6 days; those assigned to 900 mg or 300 mg received placebo for 6 days).
Studietype
Intervensjonell
Registrering (Faktiske)
104
Fase
- Fase 2
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- signed the Informed consent form (ICF)
- completed the 3-week treatment period in Protocol with identification number SCO/BIA-2093-203 or Protocol with identification number PRA/BIA-2093-204 and shown response to treatment, defined as ≥ 50% improvement in the Young Mania Rating Scale (YMRS) total score or a YMRS total score < 12
- presented a serum pregnancy test (in cases of women of childbearing potential) consistent with a non-gravid state and used double-barrier contraception throughout the study
Exclusion Criteria:
- relevant electrocardiogram (ECG) or laboratory abnormalities
- any uncontrolled clinically relevant disorder
- uninsured capability to comply with the study protocol
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: BIA 2-093 1800 mg (Group 1)
BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily).
Study medication was administered orally, once daily in the evening.
|
BIA 2-093 1800 mg taken orally in the evening, for 2 weeks
Andre navn:
|
|
Eksperimentell: BIA 2-093 900 mg (Group 2)
BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily).
Study medication was administered orally, once daily in the evening.
|
BIA 2-093 900 mg taken orally in the evening, for 2 weeks
Andre navn:
|
|
Eksperimentell: BIA 2-093 300 mg (Group 3)
BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily).
Study medication was administered orally, once daily in the evening.
|
BIA 2-093 300 mg taken orally in the evening, for 2 weeks.
Andre navn:
|
|
Eksperimentell: ESL (Part I)
In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks.
|
In Part I, patients received one 900 mg BIA 2-093 tablet once daily, taken orally in the evening, for 2 weeks.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Patients Who Showed no Worsening According to the Clinical Global Impression - Bipolar Version (CGI-BP) Scale (Intent-to-Treat Population)
Tidsramme: 6 months
|
The CGI-BP scale is a modification of the CGI scale, which provides a means of assessing severity and treatment-related improvement in manic and depressive domains reflecting clinically relevant degrees of change.
The concept of improvement refers to the clinical distance between the individual's current condition and that prior to the start of treatment.
The scale for 'severity of illness' measures mania, depression and overall illness on a 7 point scale from 1 ('normal, not ill') to 7 ('very severely ill').
The scale for 'change from preceding phase' and 'change from worst phase' measures mania, depression, and overall illness on an 8-point scale from 1 (very much improved) to 8 ('not applicable').
If the patient, in 'change from preceding phase', at any visit during the double-blind, has a score of 5, 6, or 7 in any of 3 categories (mania, depression, or overall bipolar illness), then the illness will be considered to have worsened.
|
6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Patrício Soares-da-Silva, MD, PhD, BIAL - Portela & Ca. SA
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2006
Primær fullføring (Faktiske)
1. juni 2007
Studiet fullført (Faktiske)
1. juni 2007
Datoer for studieregistrering
Først innsendt
1. april 2013
Først innsendt som oppfylte QC-kriteriene
5. april 2013
Først lagt ut (Anslag)
8. april 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
27. mars 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. februar 2014
Sist bekreftet
1. februar 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BIA-2093-205
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .