Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy

Parkinson Disease Clinical Trial

Official title:

Phase 2b/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Dipraglurant (ADX48621) for the Treatment of Dyskinesia in Patients With Parkinson's Disease Receiving Levodopa-based Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04857359
• Other study ID #: ADX48621-301
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 6, 2021
• Est. completion date: August 2023

Study information

• Verified date: May 2022
• Source: Addex Pharma S.A.
• Contact: Study Director
• Phone: 877-409-1775
• Email: addex[@]druginfo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day). The primary efficacy assessment will be based on the Unified Dyskinesia Rating Scale (UDysRS). Patients who complete the 12-week blinded treatment period may have the option to roll into an open-label safety extension study for an additional 12-month treatment period.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• Patients with Parkinson's Disease on a stable regimen of antiparkinson's medications, including a levodopa preparation administered not less than 3 times daily.

• Meet protocol-specified criteria for moderate to severe dyskinesia symptoms based on UDysRS and Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assessments.

• Meet protocol specified criteria for ON time with troublesome dyskinesia based on a standard PD home diary.

Exclusion Criteria:

• Prior surgical treatment for Parkinson's Disease (e.g., deep brain stimulation).

• Other neurological disease (including psychiatric disease and/or cognitive impairment) that, in the opinion of the investigator, would affect the patient's ability to complete study assessments.

• Other significant medical condition that may affect the safety of the patient or preclude adequate participation in the study.

• Pregnant or breast-feeding. Female patients who are of child-bearing potential must be using adequate contraceptive methods (e.g. oral contraceptive, double-barrier method, intra-uterine device, intra-muscular hormonal contraceptive), and have a negative pregnancy test at Screening.

Other protocol-defined inclusion and exclusion criteria may apply

Related Conditions & MeSH terms

• Dyskinesia, Drug-Induced
• Dyskinesias
• Parkinson Disease

Intervention

Drug:
• Dipraglurant
Oral 50mg and 100mg tablet
• Placebo
Oral matching placebo tablet

Locations

Country	Name	City	State
United States	Abington Neurologic Associates	Abington	Pennsylvania
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	Henry Ford Health System	Bingham Farms	Michigan
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton Inc	Boca Raton	Florida
United States	Cooper University Hospital	Camden	New Jersey
United States	Rush University Medical Center	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	David L Kreitzman MD PC	Commack	New York
United States	NeuroStudies.net, LLC - ClinEdge - PPDS	Decatur	Georgia
United States	Michigan State University	East Lansing	Michigan
United States	Rocky Mountain Movement Disorders Center	Englewood	Colorado
United States	Neuro-Pain Medical Center	Fresno	California
United States	Josephson Wallack Munshower Neurology PC	Indianapolis	Indiana
United States	University of California Irvine Medical Center	Irvine	California
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Evergreen Hospital Medical Center	Kirkland	Washington
United States	University of Wisconsin Hospitals and Clinics	Madison	Wisconsin
United States	Froedtert and The Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
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	Meridian Clinical Research (Norfolk, Virginia)	Norfolk	Virginia
United States	Renstar Medical Research -21 NE 1st Ave	Ocala	Florida
United States	AES - DRS - Synexus Clinical Research US, Inc. - Orlando	Orlando	Florida
United States	Neurology Associates of Ormond Beach	Ormond Beach	Florida
United States	Stanford Neuroscience Health Center	Palo Alto	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Xenosciences Inc	Phoenix	Arizona
United States	Suncoast Neuroscience Associates Inc	Saint Petersburg	Florida
United States	UT Health Science Center, San Antonio	San Antonio	Texas
United States	Avera Medical Group	Sioux Falls	South Dakota
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	University of South Florida	Tampa	Florida
United States	University of Toledo, Gardner-McMaster Parkinson Center	Toledo	Ohio
United States	Pacific Neuroscience Institute	Torrance	California
United States	Chase Family Movement Disorders Center - Vernon	Vernon	Connecticut
United States	Geodyssey Research LLC	Vero Beach	Florida
United States	Sentara Neurology Specialists	Virginia Beach	Virginia

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	Change from baseline on the Unified Dyskinesia Rating Scale (UDysRS) total score	The UDysRS is a dyskinesia rating scale scored from 0-104 that evaluates involuntary movements associated with PD. A higher score indicates more severe dyskinesia.	Baseline (Day 1) to Week 12
Secondary	Change from baseline in ON time without troublesome dyskinesia based on a standardized PD diary	A PD home diary is used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia.	Baseline (Day 1) to Week 12
Secondary	Change from baseline in OFF time based on a standardized PD diary	A PD home diary is used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia.	Baseline (Day 1) to Week 12