Phase Ib/IIa Clinical Study of ApTOLL for the Treatment of Acute Ischemic Stroke
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Stroke
- Ischemic Stroke
- Stroke
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
This is a prospective, multicenter, double-blind, randomized, placebo-controlled, Phase Ib/IIa clinical study to assess the administration of ApTOLL together with endovascular therapy in acute ischemic stroke (AIS) patients with confirmed Large Vessel Occlusion (LVO) who are candidates to receive re...
This is a prospective, multicenter, double-blind, randomized, placebo-controlled, Phase Ib/IIa clinical study to assess the administration of ApTOLL together with endovascular therapy in acute ischemic stroke (AIS) patients with confirmed Large Vessel Occlusion (LVO) who are candidates to receive reperfusion therapies including endovascular treatment with or without i.v. rt-PA (recombinant tissue Plasminogen Activator). The study will be a Phase Ib/IIa trial where 2 doses selected, based on safety criteria, on Phase Ib will be administered in the following Phase IIa.The objective of the study is to evaluate if administration of ApTOLL at different doses is safe and well tolerated compared to placebo when administered with endovascular therapy (EVT), with or without i.v. rt-PA, in the AIS target population.
Tracking Information
- NCT #
- NCT04734548
- Collaborators
- Science and Innovation Spanish Ministry
- Anagram
- Investigators
- Study Director: Marc Ribó, MD, PhD aptaTargets S.L.
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