Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy

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

Phase

2/3

Condition

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT05116813
ADX48621-302
  • Ages 30-85
  • All Genders

Study Summary

This open-label study is designed to assess the long-term safety and tolerability of dipraglurant in PD patients for up to 52 weeks (at doses of 150-300 mg per day) for patients that have completed an Addex sponsored double-blind clinical trial of dipraglurant.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Completed an Addex randomized controlled study of dipraglurant and, in the judgementof the Investigator, may benefit from open-label treatment
  • Able to take study drug 3 times daily and no less than 3 hours apart
  • Must be taking levodopa not less than 3 times daily throughout the study
  • Must maintain stable regimen of antiparkinson's medications (including levodopa) andbe willing to continue the same doses and regimens for the first 4 weeks of the study

Exclusion

Exclusion Criteria:

  • Patient is judged by the Investigator to be inappropriate for the study (for reasonssuch as, but not limited to, significant noncompliance in the Addex randomizedcontrolled study of dipraglurant)
  • Use of amantadine or amantadine ER throughout the study
  • Use of memantine throughout the study
  • Any use of marijuana or other cannabis/cannabinoid products for the first 4 weeks ofstudy participation Other protocol-defined inclusion and exclusion criteria may apply

Study Design

Total Participants: 140
Study Start date:
October 25, 2021
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Augusta University

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Rutgers, the State University of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210-1267
    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

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