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

Phase 2

Terminated

• Conditions: Dyskinesias; Dyskinesia, Drug-Induced; Parkinson Disease
• Interventions: Drug: Placebo; Drug: Dipraglurant

• Registration Number: NCT04857359
• Lead Sponsor: Addex Pharma S.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-23
• Study Start: 2021-08-06
• Primary Completion: 2022-06-17
• Study Completion: 2022-08-15
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-01
• Last Update Posted: 2025-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo TID	Placebo	-
Dipraglurant TID	Dipraglurant	-

Primary Outcome Measures

Name	Time	Method
Change from baseline on the Unified Dyskinesia Rating Scale (UDysRS) total score	Baseline (Day 1) to Week 12	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

Name	Time	Method
Change from baseline in ON time without troublesome dyskinesia based on a standardized PD diary	Baseline (Day 1) to Week 12	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	Baseline (Day 1) to Week 12	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.

Trial Locations

Locations (41)

Xenosciences Inc; 🇺🇸 Phoenix, Arizona, United States

Neuro-Pain Medical Center; 🇺🇸 Fresno, California, United States

University of California Irvine Medical Center; 🇺🇸 Irvine, California, United States

Stanford Neuroscience Health Center; 🇺🇸 Palo Alto, California, United States

Pacific Neuroscience Institute; 🇺🇸 Torrance, California, United States

Rocky Mountain Movement Disorders Center; 🇺🇸 Englewood, Colorado, United States

Chase Family Movement Disorders Center - Vernon; 🇺🇸 Vernon, Connecticut, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton Inc; 🇺🇸 Boca Raton, Florida, 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

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