ACTIVE_NOT_RECRUITING

AMX0035 and Progressive Supranuclear Palsy

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Conditions

Progressive Supranuclear PalsyPSPNeurodegenerative DiseasesAtypical ParkinsonismSteele-Richardson-Olszewski SyndromeORIONAmylyx

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2b/3 Study of the Safety and Efficacy of AMX0035 in Progressive Supranuclear Palsy (ORION)

Quick Facts

Study Start:2023-12-21
Study Completion:2029-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06122662

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female 40 to 80 years of age, inclusive
  2. * Diagnosis of possible or probable PSP Richardson Syndrome
  3. * Presence of PSP symptoms for \<5 years
  4. * Score of \<40 on the total (28-item) Progressive Supranuclear Palsy Rating Scale (PSPRS)
  5. * Able to walk independently or with minimal assistance
  6. * Minimum score of 24 on the Mini Mental State Examination (MMSE)
  7. * Must reside outside a skilled nursing facility or dementia care facility at the time of screening. Residence in an assisted living facility is allowed
  8. * Must have a study partner willing to attend study visits and provide information on participant's status
  9. * Capable of providing informed consent
  10. * Capable and willing to comply with trial procedures including visits to the trial clinic, visit requirements and treatment schedule, including MRI scans
  11. * 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.
  12. * 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.
  1. * Require use of a feeding tube
  2. * Evidence of any neurological disorder that could explain signs of PSP
  3. * Evidence of any clinically significant neurological disorder other than PSP, including significant cerebrovascular abnormalities, vascular dementia, motor neuron disease or ALS, Huntington's disease, normal pressure hydrocephalus, brain tumor, seizure disorder, multiple sclerosis, or known structural brain abnormalities.
  4. * History of autosomal dominant PSP due to a Microtubule Associated Protein Tau (MAPT) mutation
  5. * History of an autosomal dominant mutation associated with Frontotemporal Lobar Degeneration (FTLD)
  6. * Prior or current diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
  7. * Presence of unstable psychiatric disease, cognitive impairment (e.g., major cognitive dysfunction), dementia, major depression, or substance abuse that would impair ability of the participant to provide informed consent and follow instructions
  8. * Abnormal liver function
  9. * Renal insufficiency
  10. * Ongoing anemia
  11. * History of Class III/IV heart failure per New York Heart Association (NYHA)

Contacts and Locations

Principal Investigator

Study Director
STUDY_DIRECTOR
Amylyx Pharmaceuticals

Study Locations (Sites)

Mayo Clinic
Scottsdale, Arizona, 85259
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Parkinson's & Movement Disorder Institute
Fountain Valley, California, 92708
United States
University of Southern California
Los Angeles, California, 90033
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Stanford Movement Disorder Center
Palo Alto, California, 94304
United States
University of California, San Francisco (UCSF)
San Francisco, California, 94158
United States
UC Health Anschutz Outpatient Pavilion Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
United States
UF Health Dorothy Mangurian Neuroimaging Suite
Gainesville, Florida, 32608
United States
Mayo Clinic Florida
Jacksonville, Florida, 32224
United States
Augusta University
Augusta, Georgia, 30912
United States
Parkinsons and Movement Disorder Center at the Queens Medical Center
Honolulu, Hawaii, 96813
United States
Northwestern University PD and Movement Disorders Center
Chicago, Illinois, 60611
United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160
United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536-0274
United States
Ochsner Medical Center
New Orleans, Louisiana, 70121
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
United States
Quest Research Institute
Farmington Hills, Michigan, 48334
United States
University of Minnesota, CTSI
Minneapolis, Minnesota, 55414
United States
Mayo Clinic - Rochester
Rochester, Missouri, 55905
United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106
United States
University of Cincinnati
Cincinnati, Ohio, 45219
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
United States
Veracity Neuroscience, LLC
Memphis, Tennessee, 38157
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Kerwin Medical Center
Dallas, Texas, 75231
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Central Texas Neurology Consultants
Round Rock, Texas, 78681
United States
University of Utah Movement Disorders Center
Salt Lake City, Utah, 84108
United States
Virginia Commonwealth University Department of Neurology
Richmond, Virginia, 23298-0059
United States

Collaborators and Investigators

Sponsor: Amylyx Pharmaceuticals Inc.

  • Study Director, STUDY_DIRECTOR, Amylyx Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-21
Study Completion Date2029-11-30

Study Record Updates

Study Start Date2023-12-21
Study Completion Date2029-11-30

Terms related to this study

Keywords Provided by Researchers

  • Progressive Supranuclear Palsy
  • PSP
  • Steele-Richardson-Olszewski Syndrome
  • ORION
  • Amylyx

Additional Relevant MeSH Terms

  • Progressive Supranuclear Palsy
  • PSP
  • Neurodegenerative Diseases
  • Atypical Parkinsonism