At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double Blind, Multi Center, Multinational, Placebo Controlled, Single Parallel Escalating Dose Safety and Efficacy Study of ACT017 Used as an Add on Therapy on Top of Standard of Care of Acute Ischemic Stroke
In Brief
A Phase 2 clinical trial evaluating Intravenous ACT017 1000 mg and Intravenous Placebo for Acute Ischemic Stroke. Completed, enrolled 160 participants across 1 site.
Detailed Summary
To assess safety of single IV (bolus + infusion) doses of ACT017 in patients with an acute ischemic stroke in addition to best emergency standard of care (including fibrinolysis by rtPA with or without added thrombectomy), with a specific focus on hemorrhage, whether clinically symptomatic (NIHSS score + 4 points or death, without other explanation), or seen (excluding other diagnoses) on 24-hour (hr) CT scan, serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and medically important events and other safety items including biological and immunological tolerability.
Study Details
Timeline
Interventions
Add-on therapy to the standard of Care in the treatment of the acute ischemic stroke symptoms
Add-on therapy to the standard of Care in the treatment of the acute ischemic stroke symptoms