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Dipraglurant (ADX48621) for the Treatment of 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
Placebo
Sponsored by
Addex Pharma S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Dyskinesia, Levodopa-induced Dyskinesia

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xenosciences IncRecruiting
  • Neuro-Pain Medical CenterRecruiting
  • University of California Irvine Medical CenterRecruiting
  • Stanford Neuroscience Health CenterRecruiting
  • Pacific Neuroscience InstituteRecruiting
  • Rocky Mountain Movement Disorders CenterRecruiting
  • Chase Family Movement Disorders Center - VernonRecruiting
  • Parkinson's Disease and Movement Disorders Center of Boca Raton IncRecruiting
  • Renstar Medical Research -21 NE 1st AveRecruiting
  • AES - DRS - Synexus Clinical Research US, Inc. - OrlandoRecruiting
  • Neurology Associates of Ormond BeachRecruiting
  • Suncoast Neuroscience Associates IncRecruiting
  • University of South FloridaRecruiting
  • Geodyssey Research LLCRecruiting
  • Emory UniversityRecruiting
  • Augusta UniversityRecruiting
  • NeuroStudies.net, LLC - ClinEdge - PPDSRecruiting
  • Rush University Medical CenterRecruiting
  • Southern Illinois University School of MedicineRecruiting
  • Josephson Wallack Munshower Neurology PCRecruiting
  • University of Kansas Medical CenterRecruiting
  • Henry Ford Health SystemRecruiting
  • Michigan State UniversityRecruiting
  • Cooper University HospitalRecruiting
  • Rutgers, the State University of New JerseyRecruiting
  • University of New Mexico Health Sciences CenterRecruiting
  • David L Kreitzman MD PCRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • The Cleveland Clinic FoundationRecruiting
  • The Ohio State University Wexner Medical CenterRecruiting
  • University of Toledo, Gardner-McMaster Parkinson CenterRecruiting
  • Abington Neurologic AssociatesRecruiting
  • University of PennsylvaniaRecruiting
  • Avera Medical GroupRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • UT Health Science Center, San AntonioRecruiting
  • Meridian Clinical Research (Norfolk, Virginia)Recruiting
  • Sentara Neurology SpecialistsRecruiting
  • Evergreen Hospital Medical CenterRecruiting
  • University of Wisconsin Hospitals and ClinicsRecruiting
  • Froedtert and The Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dipraglurant TID

Placebo TID

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 21, 2021
Last Updated
May 18, 2022
Sponsor
Addex Pharma S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04857359
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 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 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.

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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dipraglurant TID
Arm Type
Experimental
Arm Title
Placebo TID
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dipraglurant
Other Intervention Name(s)
ADX48621
Intervention Description
Oral 50mg and 100mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral matching placebo tablet
Primary Outcome Measure Information:
Title
Change from baseline on the Unified Dyskinesia Rating Scale (UDysRS) total score
Description
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.
Time Frame
Baseline (Day 1) to Week 12
Secondary Outcome Measure Information:
Title
Change from baseline in ON time without troublesome dyskinesia based on a standardized PD diary
Description
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.
Time Frame
Baseline (Day 1) to Week 12
Title
Change from baseline in OFF time based on a standardized PD diary
Description
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.
Time Frame
Baseline (Day 1) to Week 12

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: 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
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
Xenosciences Inc
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Name
Neuro-Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Irvine Medical Center
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford Neuroscience Health Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Name
Pacific Neuroscience Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Individual Site Status
Recruiting
Facility Name
Rocky Mountain Movement Disorders Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Recruiting
Facility Name
Chase Family Movement Disorders Center - Vernon
City
Vernon
State/Province
Connecticut
ZIP/Postal Code
06066
Country
United States
Individual Site Status
Recruiting
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton Inc
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Name
Renstar Medical Research -21 NE 1st Ave
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Individual Site Status
Recruiting
Facility Name
AES - DRS - Synexus Clinical Research US, Inc. - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurology Associates of Ormond Beach
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Recruiting
Facility Name
Suncoast Neuroscience Associates Inc
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33712
Country
United States
Individual Site Status
Recruiting
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-4799
Country
United States
Individual Site Status
Recruiting
Facility Name
Geodyssey Research LLC
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Name
NeuroStudies.net, LLC - ClinEdge - PPDS
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Individual Site Status
Recruiting
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Recruiting
Facility Name
Josephson Wallack Munshower Neurology PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
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
Henry Ford Health System
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025-4334
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Individual Site Status
Recruiting
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
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
University of New Mexico Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106-2719
Country
United States
Individual Site Status
Recruiting
Facility Name
David L Kreitzman MD PC
City
Commack
State/Province
New York
ZIP/Postal Code
11725
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 Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
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
University of Toledo, Gardner-McMaster Parkinson Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
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
Facility Name
Avera Medical Group
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Health Science Center, San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3901
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research (Norfolk, Virginia)
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502-3932
Country
United States
Individual Site Status
Recruiting
Facility Name
Sentara Neurology Specialists
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Individual Site Status
Recruiting
Facility Name
Evergreen Hospital Medical Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Wisconsin Hospitals and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Name
Froedtert and The Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-0509
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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