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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05116813
Other study ID # ADX48621-302
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 25, 2021
Est. completion date December 2023

Study information

Verified date February 2022
Source Addex Pharma S.A.
Contact Study Director
Phone 877-409-1775
Email addex@druginfo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dipraglurant
Oral 50 mg and 100 mg tablet

Locations

Country Name City State
United States Abington Neurologic Associates Abington Pennsylvania
United States Augusta University Augusta Georgia
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States University of Kansas Medical Center Kansas City Kansas
United States Rutgers, the State University of New Jersey New Brunswick New Jersey
United States Icahn School of Medicine at Mount Sinai New York New York
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Addex Pharma S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Long-term safety and tolerability of dipraglurant as measured by incidence of adverse events 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. Baseline (Day 1) to Week 52
Secondary 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). 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. Baseline (Day 1) to Week 52
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