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A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS) Due to Distal [M2 Segment and Beyond] Arterial Large Vessel Occlusion (LVO) or Perforator Occlusion and Who Are Ineligible for Intravenous Thrombolysis (IVT) or Endovascular Thrombectomy (EVT)

Trial Profile

A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS) Due to Distal [M2 Segment and Beyond] Arterial Large Vessel Occlusion (LVO) or Perforator Occlusion and Who Are Ineligible for Intravenous Thrombolysis (IVT) or Endovascular Thrombectomy (EVT)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 13 Apr 2023

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At a glance

  • Drugs Afamelanotide (Primary)
  • Indications Ischaemic stroke
  • Focus Adverse reactions; Proof of concept
  • Acronyms CUV801
  • Sponsors Clinuvel Pharmaceuticals

Most Recent Events

  • 03 May 2022 Positive final results published in the Clinuvel Pharmaceuticals Media Release.
  • 22 Feb 2022 Status changed from active, no longer recruiting to completed.
  • 18 Jan 2022 Planned End Date changed from 1 Jun 2022 to 1 Feb 2022.

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