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

• Sponsor: Addex Pharma S.A. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05116813
• Collaborator: (none)
• Enrollment: 140
• Locations: 7
• Arm: 1
• Anticipated Duration (Months): 25.2
• Patients Per Site: 20
• Patients Per Site Per Month: 0.8

Study Details

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.

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

Study Design

• Study Type: Interventional
• Anticipated 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: Oct 25, 2021
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dipraglurant TID	Drug: Dipraglurant; Oral 50 mg and 100 mg tablet; Other Names: ADX48621

Outcome Measures

Primary Outcome Measures

1. Long-term safety and tolerability of dipraglurant as measured by incidence of adverse events [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). [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

Criteria

• Ages Eligible for Study: 30 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Augusta University	Augusta	Georgia	United States	30912
2	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
3	Rutgers, the State University of New Jersey	New Brunswick	New Jersey	United States	08901
4	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
5	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210-1267
6	Abington Neurologic Associates	Abington	Pennsylvania	United States	19001-3816
7	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Addex Pharma S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Addex Pharma S.A.
• ClinicalTrials.gov Identifier: NCT05116813
• Other Study ID Numbers: ADX48621-302
• First Posted: Nov 11, 2021
• Last Update Posted: Apr 25, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Parkinson Disease; Dyskinesias; Dyskinesia, Drug-Induced

Study Results

No Results Posted as of Apr 25, 2022