Einleitung wieder einblenden
SNCTP000003095 | NCT02864953 | BASEC2018-01727

Studio randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, multicentrico, di fase 3 per valutare l’efficacia e la sicurezza di BIIB093 (glibenclamide) per via endovenosa per grave edema cerebrale in seguito a un grande infarto emisferico

Datenbasis: BASEC (Import vom 27.01.2022), WHO (Import vom 18.01.2022)
Geändert: 25.11.2021
Krankheitskategorie: Hirnerkrankungen (nicht Krebs)

Zusammenfassende Beschreibung der Studie (Datenquelle: BASEC)

Lo scopo di questo studio è determinare se BIIB093 migliori gli esiti funzionali (la capacità di svolgere le normali attività quotidiane, come camminare e vestirsi) dei partecipanti che hanno avuto un tipo di ictus, chiamato infarto emisferico esteso , rispetto al placebo dopo 90 giorni. Questo studio esaminerà anche la sopravvivenza a 90 giorni e verificherà la sicurezza e tollerabilità di BIIB093.
Prenderanno parte a questo studio circa 680 partecipanti in tutto il mondo.

Untersuchte Krankheiten (Datenquelle: BASEC)

grande infarto emisferico

Health conditions (Datenquelle: WHO)

Brain Edema;Stroke, Acute

Seltene Krankheit (Datenquelle: BASEC)

Nein

Untersuchte Intervention (z.B. Medikament, Therapie, Kampagne) (Datenquelle: BASEC)

Il trattamento dello studio verrà somministrato una volta attraverso un ago nella vena. Sarà somministrato ininterrottamente per 72 ore (3 giorni).

Interventions (Datenquelle: WHO)

Drug: BIIB093;Drug: Placebo

Kriterien zur Teilnahme an der Studie (Datenquelle: BASEC)

- Una diagnosi clinica di ictus ischemico acuto nel territorio dell’arteria cerebrale media.- Età compresa tra 18 e 85 anni, compresi.
- Screening National Institutes of Health Stroke Scale (NIHSS) ≥10
- Infusione del trattamento dello studio entro 10 ore dall’insorgenza dei sintomi o dal visto sano l’ultima volta.
- Prima del colpo attuale, nessuna disabilità significativa

Ausschlusskriterien (Datenquelle: BASEC)

1. Probabilità di ritiro di cure di supporto nel primo giorno.
2. Impegno per la craniectomia decompressiva prima dell'arruolamento.
3. Evidenza di infarto concomitante nell'emisfero controlaterale sufficientemente serio da influire sull'esito funzionale.

Inclusion/Exclusion Criteria (Datenquelle: WHO)


Inclusion Criteria:

1. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA)
territory.

2. A large hemispheric infarction defined as; lesion volume of 80 to 300 centimeters
cubed (cm^3) on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or
computed tomography perfusion (CTP), or an Alberta Stroke Program Early CT Score
(ASPECTS) of 1 to 5 with involvement of at least 2 defined cortical regions.

3. Screening National Institutes of Health Stroke Scale (NIHSS) >=10.

4. At the time of randomization, and in the Investigator's judgement, it must be feasible
for study drug treatment infusion to be initiated no later than 10 hours after time of
symptom onset, if known, or the time last known normal.

- Participants who wake with stroke may be included if neurological and other
exclusion criteria are satisfied. The time of stroke onset is to be taken as the
midpoint between sleep onset (or last known to be normal) and time of waking. .

5. For participants who receive thrombectomy, inclusion into the study must be based on
post-thrombectomy MRI-DWI.

Exclusion Criteria:

1. Participant is likely to have supportive care withdrawn on the first day.

2. Commitment to decompressive craniectomy (DC) prior to enrollment.

3. Evidence of concurrent infarction in the contralateral hemisphere sufficiently serious
so as to affect functional outcome.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Weitere Angaben zur Studie im WHO-Primärregister

https://clinicaltrials.gov/show/NCT02864953

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02864953

Weitere Informationen zur Studie

Registrationsdatum der Studie

12.07.2016

Einschluss der ersten teilnehmenden Person

29.08.2018

Rekrutierungsstatus

Recruiting

Wissenschaftlicher Titel (Datenquelle: WHO)

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction

Studientyp (Datenquelle: WHO)

Interventional

Design der Studie (Datenquelle: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).

Phase (Datenquelle: WHO)

Phase 3

Primäre Endpunkte (Datenquelle: WHO)

Part 1: Percentage of Participants with Improvement in Functional Outcome at Day 90 Assessed via the Modified Rankin Scale (mRS)

Sekundäre Endpunkte (Datenquelle: WHO)

Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Part 1: Reduction in Midline Shift at 72 Hours;Part 1: Number of Participants Who Achieved mRS 0-4 at Day 90;Part 1: Time to All-Cause Death

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors

Ergebnisse der Studie (Datenquelle: WHO)

Zusammenfassung der Ergebnisse

noch keine Angaben verfügbar

Link zu den Ergebnissen im Primärregister

noch keine Angaben verfügbar

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten

noch keine Angaben verfügbar

Studiendurchführungsorte

Durchführungsorte in der Schweiz (Datenquelle: BASEC)

Aarau, Bern, Lugano

Durchführungsländer (Datenquelle: WHO)

Australia, Belgium, Brazil, Canada, China, Croatia, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Japan, Korea, Lithuania, Portugal, Republic of, Russian Federation, Spain, Switzerland, Taiwan, United Kingdom, United States

Kontakt für weitere Auskünfte zur Studie

Angaben zur Kontaktperson in der Schweiz (Datenquelle: BASEC)

Dr. Carlo Cereda
+41 91 811 66 91
Carlo.Cereda@eoc.ch

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Medical Director;US Biogen Clinical Trial Center
Biogen
866-633-4636
clinicaltrials@biogen.com

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Medical Director;US Biogen Clinical Trial Center
Biogen
866-633-4636
clinicaltrials@biogen.com

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

Biogen

Bewilligung durch Ethikkommission (Datenquelle: BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Comitato etico cantonale Ticino

Datum der Bewilligung durch die Ethikkommission

11.12.2018

Weitere Studienidentifikationsnummern

Studienidentifikationsnummer der Ethikkommission (BASEC-ID) (Datenquelle: BASEC)

2018-01727

Secondary ID (Datenquelle: WHO)

RPI 301
2017-004854-41
252LH301