Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy

Last updated: May 18, 2022
Sponsor: Addex Pharma S.A.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT04857359
ADX48621-301
  • Ages 30-85
  • All Genders

Study Summary

This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day). The primary efficacy assessment will be based on the Unified Dyskinesia Rating Scale (UDysRS). Patients who complete the 12-week blinded treatment period may have the option to roll into an open-label safety extension study for an additional 12-month treatment period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with Parkinson's Disease on a stable regimen of antiparkinson's medications,including a levodopa preparation administered not less than 3 times daily.
  • Meet protocol-specified criteria for moderate to severe dyskinesia symptoms based onUDysRS and Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assessments.
  • Meet protocol specified criteria for ON time with troublesome dyskinesia based on astandard PD home diary.

Exclusion

Exclusion Criteria:

  • Prior surgical treatment for Parkinson's Disease (e.g., deep brain stimulation).
  • Other neurological disease (including psychiatric disease and/or cognitive impairment)that, in the opinion of the investigator, would affect the patient's ability tocomplete study assessments.
  • Other significant medical condition that may affect the safety of the patient orpreclude adequate participation in the study.
  • Pregnant or breast-feeding. Female patients who are of child-bearing potential must beusing adequate contraceptive methods (e.g. oral contraceptive, double-barrier method,intra-uterine device, intra-muscular hormonal contraceptive), and have a negativepregnancy test at Screening. Other protocol-defined inclusion and exclusion criteria may apply

Study Design

Total Participants: 140
Study Start date:
August 06, 2021
Estimated Completion Date:
August 31, 2023

Connect with a study center

  • Xenosciences Inc

    Phoenix, Arizona 85004
    United States

    Active - Recruiting

  • Neuro-Pain Medical Center

    Fresno, California 93710
    United States

    Active - Recruiting

  • University of California Irvine Medical Center

    Irvine, California 92697
    United States

    Active - Recruiting

  • Stanford Neuroscience Health Center

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Pacific Neuroscience Institute

    Torrance, California 90503
    United States

    Active - Recruiting

  • Rocky Mountain Movement Disorders Center

    Englewood, Colorado 80113
    United States

    Active - Recruiting

  • Chase Family Movement Disorders Center - Vernon

    Vernon, Connecticut 06066
    United States

    Active - Recruiting

  • Parkinson's Disease and Movement Disorders Center of Boca Raton Inc

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Renstar Medical Research -21 NE 1st Ave

    Ocala, Florida 34471
    United States

    Active - Recruiting

  • AES - DRS - Synexus Clinical Research US, Inc. - Orlando

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida 32174
    United States

    Active - Recruiting

  • Suncoast Neuroscience Associates Inc

    Saint Petersburg, Florida 33712
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33612-4799
    United States

    Active - Recruiting

  • Geodyssey Research LLC

    Vero Beach, Florida 32960
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Augusta University

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • NeuroStudies.net, LLC - ClinEdge - PPDS

    Decatur, Georgia 30033
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois 62702
    United States

    Active - Recruiting

  • Josephson Wallack Munshower Neurology PC

    Indianapolis, Indiana 46256
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Henry Ford Health System

    Bingham Farms, Michigan 48025-4334
    United States

    Active - Recruiting

  • Michigan State University

    East Lansing, Michigan 48824
    United States

    Active - Recruiting

  • Cooper University Hospital

    Camden, New Jersey 08103
    United States

    Active - Recruiting

  • Rutgers, the State University of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico 87106-2719
    United States

    Active - Recruiting

  • David L Kreitzman MD PC

    Commack, New York 11725
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210-1267
    United States

    Active - Recruiting

  • University of Toledo, Gardner-McMaster Parkinson Center

    Toledo, Ohio 43614
    United States

    Active - Recruiting

  • Abington Neurologic Associates

    Abington, Pennsylvania 19001-3816
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Avera Medical Group

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • UT Health Science Center, San Antonio

    San Antonio, Texas 78229-3901
    United States

    Active - Recruiting

  • Meridian Clinical Research (Norfolk, Virginia)

    Norfolk, Virginia 23502-3932
    United States

    Active - Recruiting

  • Sentara Neurology Specialists

    Virginia Beach, Virginia 23456
    United States

    Active - Recruiting

  • Evergreen Hospital Medical Center

    Kirkland, Washington 98034
    United States

    Active - Recruiting

  • University of Wisconsin Hospitals and Clinics

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin 53226-0509
    United States

    Active - Recruiting

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