Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy
Primary Purpose
Parkinson Disease, Dyskinesia, Drug-Induced, Dyskinesias
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dipraglurant
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Dyskinesia, Levodopa-induced Dyskinesia
Eligibility 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
Sites / Locations
- Augusta UniversityRecruiting
- University of Kansas Medical CenterRecruiting
- Rutgers, the State University of New JerseyRecruiting
- Icahn School of Medicine at Mount SinaiRecruiting
- The Ohio State University Wexner Medical CenterRecruiting
- Abington Neurologic AssociatesRecruiting
- University of PennsylvaniaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dipraglurant TID
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05116813
Brief Title
Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Addex Pharma S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Dyskinesia, Drug-Induced, Dyskinesias
Keywords
Parkinson's disease, Dyskinesia, Levodopa-induced Dyskinesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dipraglurant TID
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dipraglurant
Other Intervention Name(s)
ADX48621
Intervention Description
Oral 50 mg and 100 mg tablet
Primary Outcome Measure Information:
Title
Long-term safety and tolerability of dipraglurant as measured by incidence of adverse events
Description
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.
Time Frame
Baseline (Day 1) to Week 52
Secondary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
Baseline (Day 1) to Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
877-409-1775
Email
addex@druginfo.com
Facility Information:
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers, the State University of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1267
Country
United States
Individual Site Status
Recruiting
Facility Name
Abington Neurologic Associates
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001-3816
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy
We'll reach out to this number within 24 hrs