1,4-DIAMINO-2,3-DICYANO-1,4-BIS(O-AMINOPHENYLMERCAPTO)BUTADIENE HEMIETHANOLATE for Subarachnoid haemorrhage

Inclusion criteria

• {"criterion_text":"- Male or female patients aged 18-80 years (both inclusive)\n- Moderate or severe SAH diagnosed with CT and caused (or suspected to be caused) by a ruptured saccular aneurysm with symptoms less than 8 hours\n- Intracerebroventricular access obtained within 8 h from start of symptoms\n- A WFNS score 1-5, assessed at any time after SAH diagnosis, but before first dose of IMP\n- Informed consent obtained from a trial guardian prior to initiation of any trial-related procedures."}

Exclusion criteria

• {"criterion_text":"- The SAH due to other causes (e.g., trauma, rupture of fusiform or mycotic aneurysms)\n- Intraventricular or intracerebral blood, in the absence of subarachnoid blood\n- Expected survival < 48 hours\n- Any severe or unstable chronic or acute concomitant condition, which, in the opinion of the PI/delegate, would affect the assessment of the safety of the IMP\n- Any known or CT evidence of previous major cerebral damage or preexisting cerebrovascular disorders, which in the opinion of the PI/delegate may affect the accurate diagnosis and evaluation of SAH\n- Participation in any other clinical trial with an experimental drug within the last 12 weeks\n- Known allergy to the IMP or its constituents\n- Female patients who are pregnant or breastfeeding. Women of childbearing potential must have a negative plasma or urine pregnancy test at screening"}

Primary endpoints

• {"endpoint_text":"- Frequency of TEAEs, SAEs and severe TEAEs, change from baseline in vital signs, laboratory results, OS","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Clinical outcomes as measured by: a. National Institute of Health Stroke Scale (NIHSS) on Day 14 or at discharge, whichever comes first. b. Modified Rankin Scale (mRS) at discharge from the NICU or the Neurosurgical Stepdown Unit, Day 28 and 84 after SAH. c. Extended Glasgow Outcome Scale (GOS-E) at discharge from neurosurgical care, Day 28 and 84 after SAH","definition_or_measurement_approach":"NIHSS assessed on Day 14 or at discharge; mRS assessed at discharge, Day 28 and Day 84; GOS-E assessed at discharge, Day 28 and Day 84."}
• {"endpoint_text":"- Number of days spent in NICU, the Neurosurgical Stepdown Unit, in hospital of trial site, and (if transferred) in any hospital","definition_or_measurement_approach":"Count of days spent in specified units/hospitals as recorded in patient hospitalization records."}
• {"endpoint_text":"- Pharmacokinetic endpoints: a. Plasma: i. Maximum (peak) concentration (Cmax) ii. Nominal time for the occurrence of Cmax (Tmax) iii. Area under the concentration-time curve from 0 to time t (AUC0-t)","definition_or_measurement_approach":"Plasma PK parameters Cmax, Tmax, AUC0-t calculated from plasma concentration-time profiles."}
• {"endpoint_text":"- Pharmacokinetic endpoints: b. CSF: i. Concentration of EDV2209 at the selected sampling times ii. Concentration of EDV2209 at the selected sampling times relative to the plasma concentrations of EDV2209 at the same time points (CSF/plasma ratios) iii.Maximum (peak) concentration (Cmax) iv.Nominal time for the occurrence of Cmax (Tmax) v.Area under the concentration-time curve from 0 to time t (AUC0-t)","definition_or_measurement_approach":"CSF PK parameters: CSF concentrations at sampling times, CSF/plasma ratios, Cmax, Tmax, AUC0-t derived from CSF and paired plasma samples."}

Denmark

Earliest CTIS Part Ii Submission Date

17-07-2024

Latest Decision Or Authorization Date

12-12-2024

Processing Time Days

148

Number Of Sites

2

Number Of Participants

51

Primary sponsor

Full Name

Edvince AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Fortrea Inc.

Responsibilities

Sponsor-related duties (codes listed in source): 1, 10, 11, 12, 6, 8, 9

Name

Lablytica Life Science AB

Responsibilities

Pharmacokinetic bioanalysis

Name

Medidata Solutions Inc.

Responsibilities

Data/electronic systems (sponsor duty code 7)

Name

SDL Limited

Responsibilities

Translation

Name

Rechon Life Science AB

Responsibilities

IMP packaging, labelling and distribution

Third parties

• {"country":"Sweden","full_name":"Lablytica Life Science AB","duties_or_roles":"Pharmacokinetic bioanalysis","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Sponsor duties codes: 1, 10, 11, 12, 6, 8, 9 (roles provided as duty codes in source data)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duties code: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"SDL Limited","duties_or_roles":"Translation","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Sweden","full_name":"Rechon Life Science AB","duties_or_roles":"IMP packed, labelled and distributed","organisation_type":"Pharmaceutical company"}