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AMX0035 and Progressive Supranuclear Palsy

  • Status
    Accepting Candidates
  • Age
    40 Years - 80 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

A35-009 (ORION) is a Phase 2b/3 trial to evaluate the efficacy and safety of AMX0035 in participants with Progressive Supranuclear Palsy (PSP), consisting of randomized, double blind placebo controlled phases, followed by an optional open-label extension phase.

Description

AMX0035 is a fixed dose combination therapy designed to reduce neuronal death through blockade of key cellular death pathways originating in the endoplasmic reticulum (ER) and mitochondria. This clinical trial is designed to demonstrate that AMX0035 is safe and tolerable, and to assess its effect on disease progression as measured by the Progressive Supranuclear Palsy (PSP) Rating Scale (PSPRS) over a 52-week double-blind phase. The

Phase 2b and Phase 3 study portions are planned to feature an identical design: a randomized, double-blind, placebo-controlled phase that is followed by an optional open-label extension (OLE) phase. The phase 3 portion of ORION may be initiated based on results of the phase 2b Interim Analysis and/or the Primary Analysis and the totality of data from the Phase 2b study portion.

Details

Full study title A Phase 3 Study of Safety and Efficacy of AMX0035 in Progressive Supranuclear Palsy (ORION)
Protocol number OCR45325
ClinicalTrials.gov ID NCT06122662
Phase Phase 2/Phase 3

Eligibility

Inclusion Criteria:

  • Male or female 40 to 80 years of age, inclusive

  • Diagnosis of possible or probable PSP Richardson Syndrome

  • Presence of PSP symptoms for

Lead researcher

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    1

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

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  4. Step
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