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A Multicenter, Patient and Investigator-Blinded, Placebo-Controlled Proof-Of-Concept Study to Determine the Safety, Tolerability and Central Nervous System (CNS) Exposure of Oral RTB101 and Sirolimus Alone or in Combination in Patients with Mild-Moderate Parkinson's Disease (PD)

Trial Profile

A Multicenter, Patient and Investigator-Blinded, Placebo-Controlled Proof-Of-Concept Study to Determine the Safety, Tolerability and Central Nervous System (CNS) Exposure of Oral RTB101 and Sirolimus Alone or in Combination in Patients with Mild-Moderate Parkinson's Disease (PD)

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 12 May 2020

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At a glance

  • Drugs Dactolisib (Primary) ; Sirolimus (Primary)
  • Indications Parkinson's disease
  • Focus Adverse reactions; Proof of concept
  • Sponsors resTORbio
  • Most Recent Events

    • 07 May 2020 According to a resTORbio media release, the company plans to analyze the data from the four completed dosing arms and data from the four completed cohorts is expected by mid-2020.
    • 07 May 2020 Status changed from recruiting to discontinued, according to a resTORbio media release. To ensure safety of the clinical trial participants and the study coordinators, resTORbio has decided to terminate the study and not to enroll the fifth cohort due to the COVID-19 level 4 alert in New Zealand.
    • 03 Apr 2020 According to a resTORbio media release, the company have postponed enrollment in the fifth cohort due to COVID-19 level 4 alert in New Zealand. Enrollment in the first four cohorts has been completed
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