AMX0035 and Progressive Supranuclear Palsy (NCT06122662) | Clinical Trial Compass
CompletedPhase 2/3
AMX0035 and Progressive Supranuclear Palsy
United States139 participantsStarted 2023-12-21
Plain-language summary
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.
Who can participate
Age range40 Years – 80 Years
SexALL
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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 \<5 years
* Score of \<40 on the total (28-item) Progressive Supranuclear Palsy Rating Scale (PSPRS)
* Able to walk independently or with minimal assistance
* Minimum score of 24 on the Mini Mental State Examination (MMSE)
* Must reside outside a skilled nursing facility or dementia care facility at the time of screening. Residence in an assisted living facility is allowed
* Must have a study partner willing to attend study visits and provide information on participant's status
* Capable of providing informed consent
* Capable and willing to comply with trial procedures including visits to the trial clinic, visit requirements and treatment schedule, including MRI scans
* Female participants of childbearing potential must agree to use effective birth control for the duration of the study and for 6 months after last dose of study drug.
* Males must agree to use effective birth control method for the duration of the study and for 6 months after the last dose of study drug. Men must not plan to donate sperm.
Exclusion Criteria:
* Require use of a feeding tube
* Evidence of any neurological disorder that could explain signs of PSP
* Evidence of any clinically significant neurological disorder other than PSP, including significant cerebrovascular abnormalities, vascular dementia, motor neuron disease or ALS, Huntington's…
What they're measuring
1
Change in total (28-item) Progressive Supranuclear Palsy Rating Scale (PSPRS) Score