Clinical trial NCT04857359: Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Parkinson Disease
Dyskinesia, Drug-Induced
Dyskinesias
Keywords: Parkinson's disease
Dyskinesia
Levodopa-induced Dyskinesia
Lead sponsor: Addex Pharma S.A.
Sponsor class: INDUSTRY
First posted: 2021-04-23
Enrollment: 140
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline on the Unified Dyskinesia Rating Scale (UDysRS) total score
timeFrame: Baseline (Day 1) to Week 12
Secondary outcomes:
measure: Change from baseline in ON time without troublesome dyskinesia based on a standardized PD diary
timeFrame: Baseline (Day 1) to Week 12
measure: Change from baseline in OFF time based on a standardized PD diary
timeFrame: Baseline (Day 1) to Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Xenosciences Inc
state: Arizona
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Irvine
country: United States
facility: University of California Irvine Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford Neuroscience Health Center
state: California
city: Torrance
country: United States
facility: Pacific Neuroscience Institute
state: California
city: Englewood
country: United States
facility: Rocky Mountain Movement Disorders Center
state: Colorado
city: Vernon
country: United States
facility: Chase Family Movement Disorders Center - Vernon
state: Connecticut
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton Inc
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research -21 NE 1st Ave
state: Florida
city: Orlando
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Orlando
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Saint Petersburg
country: United States
facility: Suncoast Neuroscience Associates Inc
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Vero Beach
country: United States
facility: Geodyssey Research LLC
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Decatur
country: United States
facility: NeuroStudies.net, LLC - ClinEdge - PPDS
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology PC
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Bingham Farms
country: United States
facility: Henry Ford Health System
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers, the State University of New Jersey
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Commack
country: United States
facility: David L Kreitzman MD PC
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo, Gardner-McMaster Parkinson Center
state: Ohio
city: Abington
country: United States
facility: Abington Neurologic Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Avera Medical Group
state: South Dakota
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: UT Health Science Center, San Antonio
state: Texas
city: Norfolk
country: United States
facility: Meridian Clinical Research (Norfolk, Virginia)
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Neurology Specialists
state: Virginia
city: Kirkland
country: United States
facility: Evergreen Hospital Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospitals and Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert and The Medical College of Wisconsin
state: Wisconsin
Study officials:
References: