Phase
Condition
Dyskinesias
Progressive Supranuclear Palsy
Cataplexy
Treatment
Placebo
AMX0035
Clinical Study ID
Ages 40-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 timeof screening. Residence in an assisted living facility is allowed
Must have a study partner willing to attend study visits and provide information onparticipant's status
Capable of providing informed consent
Capable and willing to comply with trial procedures including visits to the trialclinic, visit requirements and treatment schedule, including MRI scans
Female participants of childbearing potential must agree to use effective birthcontrol for the duration of the study and for 6 months after last dose of studydrug.
Males must agree to use effective birth control method for the duration of the studyand for 6 months after the last dose of study drug. Men must not plan to donatesperm.
Exclusion
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 neurondisease or ALS, Huntington's disease, normal pressure hydrocephalus, brain tumor,seizure disorder, multiple sclerosis, or known structural brain abnormalities.
History of autosomal dominant PSP due to a Microtubule Associated Protein Tau (MAPT)mutation
History of an autosomal dominant mutation associated with Frontotemporal LobarDegeneration (FTLD)
Prior or current diagnosis of schizophrenia, schizoaffective disorder, or bipolardisorder
Presence of unstable psychiatric disease, cognitive impairment (e.g., majorcognitive dysfunction), dementia, major depression, or substance abuse that wouldimpair ability of the participant to provide informed consent and followinstructions
Abnormal liver function
Renal insufficiency
Ongoing anemia
History of Class III/IV heart failure per New York Heart Association (NYHA)
Study Design
Study Description
Connect with a study center
Hôpital de la Timone
Marseille cedex 05, Bouches-du-Rhône 13385
FranceSite Not Available
Hopital Caremeau
Nimes Cedex 09, Gard 30029
FranceSite Not Available
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
Bordeaux cedex, Gironde 30076
FranceSite Not Available
CHU de Limoges - Hôpital Dupuytren
Limoges, Haute Vienne 87042
FranceSite Not Available
CHU Rennes - Hopital Pontchaillou
Rennes cedex 09, Ille Et Vilaine 35033
FranceSite Not Available
Hopital Roger Salengro - CHU Lille
Lille Cedex, Nord 59037
FranceSite Not Available
Groupe Hospitalier Pitie-Salpetriere
Paris, 75013
FranceSite Not Available
Universitaetsklinikum Duesseldorf AoeR
Ulm, Baden Wuerttemberg 89081
GermanySite Not Available
Universitaetsklinikum Ulm
Ulm, Baden Wuerttemberg 89081
GermanySite Not Available
Krankenhaus Agatharied
Hausham, Bayern 83734
GermanySite Not Available
Klinikum der Universität München
Muenchen, Bayern
GermanySite Not Available
Paracelsus-Elena-Klinik Kassel
Kassel, Hessen 34128
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Sachsen 1307
GermanySite Not Available
Asklepios Fachklinikum Stadtroda
Stadtroda, Thueringen 7646
GermanySite Not Available
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milano, 20122
ItalySite Not Available
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milano, 20133
ItalySite Not Available
Azienda Ospedale-Università di Padova
Padova, 35128
ItalySite Not Available
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, 185
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 168
ItalySite Not Available
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno, 84131
ItalySite Not Available
Hospital de Cruces
Barakaldo, Bizkaia 48903
SpainSite Not Available
Clinica Universidad de Navarra
Pamplona, Navarra 31008
SpainSite Not Available
Hospital Universitari i Politecnic La Fe
Valencia, València 46026
SpainSite Not Available
Hospital Clinic de Barcelona
Barcelona, 8036
SpainSite Not Available
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainSite Not Available
Hospital Universitario de La Princesa
Madrid, 28006
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Seville, 41013
SpainSite Not Available
Mayo Clinic
Scottsdale, Arizona 85259
United StatesSite Not Available
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United StatesSite Not Available
Parkinson's & Movement Disorder Institute
Fountain Valley, California 92708
United StatesSite Not Available
Cedars Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
University of Southern California
Los Angeles, California 90033
United StatesSite Not Available
Stanford Movement Disorder Center
Palo Alto, California 94304
United StatesSite Not Available
University of California, San Francisco (UCSF)
San Francisco, California 94158
United StatesSite Not Available
UC Health Anschutz Outpatient Pavilion Anschutz Medical Campus
Aurora, Colorado 80045
United StatesSite Not Available
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida 33486
United StatesSite Not Available
UF Health Dorothy Mangurian Neuroimaging Suite
Gainesville, Florida 32608
United StatesSite Not Available
Mayo Clinic Florida
Jacksonville, Florida 32224
United StatesSite Not Available
Augusta University
Augusta, Georgia 30912
United StatesSite Not Available
Parkinsons and Movement Disorder Center at the Queens Medical Center
Honolulu, Hawaii 96813
United StatesSite Not Available
Northwestern University PD and Movement Disorders Center
Chicago, Illinois 60611
United StatesSite Not Available
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kentucky Medical Center
Lexington, Kentucky 40536-0274
United StatesSite Not Available
Ochsner Medical Center
New Orleans, Louisiana 70121
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
United StatesSite Not Available
Quest Research Institute
Farmington Hills, Michigan 48334
United StatesSite Not Available
University of Minnesota, CTSI
Minneapolis, Minnesota 55414
United StatesSite Not Available
Mayo Clinic - Rochester
Rochester, Missouri 55905
United StatesSite Not Available
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada 89106
United StatesSite Not Available
University of Cincinnati
Cincinnati, Ohio 45219
United StatesSite Not Available
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Pennsylvania Hospital
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425
United StatesSite Not Available
Veracity Neuroscience, LLC
Memphis, Tennessee 38157
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Kerwin Medical Center
Dallas, Texas 75231
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
Central Texas Neurology Consultants
Round Rock, Texas 78681
United StatesSite Not Available
University of Utah Movement Disorders Center
Salt Lake City, Utah 84108
United StatesSite Not Available
Virginia Commonwealth University Department of Neurology
Richmond, Virginia 23298-0059
United StatesSite Not Available
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