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Trial record 1 of 5 for:    Dipraglurant
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Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy

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ClinicalTrials.gov Identifier: NCT05116813
Recruitment Status : Recruiting
First Posted : November 11, 2021
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Addex Pharma S.A.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Dyskinesia, Drug-Induced Dyskinesias Drug: Dipraglurant Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy With or Without Concomitant Dopaminergic Medications
Actual Study Start Date : October 25, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dipraglurant TID Drug: Dipraglurant
Oral 50 mg and 100 mg tablet
Other Name: ADX48621


Outcome Measures
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Primary Outcome Measures :
  1. Long-term safety and tolerability of dipraglurant as measured by incidence of adverse events [ Time Frame: Baseline (Day 1) to Week 52 ]
    Testing the safety and tolerability of dipraglurant in patients with Parkinson's Disease Levodopa-induced dyskinesia based on the incidence of adverse events reported by patients and/or as identified by the Investigator based on clinical assessments conducted during the study.


Secondary Outcome Measures :
  1. Evaluate the continued utility of dipraglurant on dyskinesia as assessed by a change-from-baseline score on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). [ Time Frame: Baseline (Day 1) to Week 52 ]
    The MDS-UPDRS is a Parkinson's Disease (PD) rating scale scored from 0-272; it evaluates progression of disease in patients with PD. A higher score indicates more severe PD.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed an Addex randomized controlled study of dipraglurant and, in the judgement of 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) and be willing to continue the same doses and regimens for the first 4 weeks of the study

Exclusion Criteria:

  • Patient is judged by the Investigator to be inappropriate for the study (for reasons such as, but not limited to, significant noncompliance in the Addex randomized controlled 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 of study participation

Other protocol-defined inclusion and exclusion criteria may apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05116813


Contacts
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Contact: Study Director 877-409-1775 addex@druginfo.com

Locations
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United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
United States, New Jersey
Rutgers, the State University of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08901
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210-1267
United States, Pennsylvania
Abington Neurologic Associates Recruiting
Abington, Pennsylvania, United States, 19001-3816
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Addex Pharma S.A.
More Information
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Responsible Party: Addex Pharma S.A.
ClinicalTrials.gov Identifier: NCT05116813    
Other Study ID Numbers: ADX48621-302
First Posted: November 11, 2021    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Addex Pharma S.A.:
Parkinson's disease
Dyskinesia
Levodopa-induced Dyskinesia
Additional relevant MeSH terms:
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Parkinson Disease
Dyskinesias
Dyskinesia, Drug-Induced
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Neurologic Manifestations
Neurotoxicity Syndromes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning