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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

Data source: BASEC (Imported from 29.11.2021), WHO (Imported from 18.04.2021)
Changed: 25.11.2021
Disease category: Brain diseases (non cancer)

Brief description of trial (Data source: 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.

Health conditions investigated (Data source: BASEC)

grande infarto emisferico

Health conditions (Data source: WHO)

Brain Edema;Stroke, Acute

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

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

Interventions (Data source: WHO)

Drug: BIIB093;Drug: Placebo

Criteria for participation in trial (Data source: 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

Exclusion criteria (Data source: 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 (Data source: 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

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02864953

Further information on the trial from WHO database (ICTRP)

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

Further information on trial

Date trial registered

12.07.2016

Incorporation of the first participant

29.08.2018

Recruitment status

Recruiting

Academic title (Data source: 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

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

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

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: WHO)

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

Secundary end point (Data source: 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

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Aarau, Bern, Lugano

Countries (Data source: 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

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

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

Contact for general information (Data source: WHO)

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

Contact for scientific information (Data source: WHO)

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

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Biogen

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Comitato etico cantonale Ticino

Date of authorisation by the ethics committee

11.12.2018

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2018-01727

Secondary ID (Data source: WHO)

RPI 301
2017-004854-41
252LH301