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

Phase 3TerminatedNCT04857359

Addex Pharma S.A.25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Parkinson Disease Dyskinesia, Drug-Induced Dyskinesias

Interventions

Eligibility

Sex: ALLMin age: 30 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline (Day 1) to Week 12

Secondary Outcomes

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.

Time frame: Baseline (Day 1) to Week 12

Change from baseline in OFF time based on a standardized PD diary

Time frame: Baseline (Day 1) to Week 12