Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy
NCT05116813 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2025-08-06
Summary
This open-label study is designed to assess the long-term safety and tolerability of dipraglurant in PD patients for up to 52 weeks (at doses of 150-300 mg per day) for patients that have completed an Addex sponsored double-blind clinical trial of dipraglurant.
Conditions
- Parkinson Disease
- Dyskinesia, Drug-Induced
- Dyskinesias
Interventions
- DRUG
-
Dipraglurant
Oral 50 mg and 100 mg tablet
Sponsors & Collaborators
-
Addex Pharma S.A.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 30 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-25
- Primary Completion
- 2022-06-17
- Completion
- 2022-08-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease
NCT01049984 ·Status: COMPLETED ·Phase: PHASE4
-
Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)
NCT00623103 ·Status: COMPLETED ·Phase: PHASE3
-
Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.
NCT00203177 ·Status: COMPLETED ·Phase: PHASE3
-
Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550)
NCT00845000 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients
NCT00203164 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
NCT00986414 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Efficacy, Safety, and Tolerability of PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED)
NCT03331848 ·Status: WITHDRAWN ·Phase: PHASE2
-
Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
NCT01491529 ·Status: COMPLETED ·Phase: PHASE2
-
A Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia.
NCT00903838 ·Status: TERMINATED ·Phase: PHASE2
-
Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off
NCT00642356 ·Status: TERMINATED ·Phase: PHASE4
-
A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066
NCT01130493 ·Status: COMPLETED ·Phase: PHASE3
-
Dyskinesia in Parkinson's Disease (Study P04501)
NCT00406029 ·Status: COMPLETED ·Phase: PHASE2
-
Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
NCT01173731 ·Status: COMPLETED ·Phase: PHASE2
-
An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)
NCT01215227 ·Status: TERMINATED ·Phase: PHASE3
-
Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations
NCT00203034 ·Status: COMPLETED ·Phase: PHASE3
-
Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease
NCT04157933 ·Status: COMPLETED ·Phase: PHASE1
-
A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402)
NCT01294800 ·Status: COMPLETED ·Phase: PHASE2
-
Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations
NCT01634360 ·Status: TERMINATED ·Phase: PHASE2
-
Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)
NCT01227265 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients
NCT03162874 ·Status: COMPLETED ·Phase: PHASE2
-
Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)
NCT00537017 ·Status: COMPLETED ·Phase: PHASE2
-
A Study With an Increased Dose Step in Patients That Have Previously Received Placebo or sNN0031.
NCT01829867 ·Status: TERMINATED ·Phase: PHASE1
-
A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease
NCT00866502 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
NCT01385592 ·Status: COMPLETED ·Phase: PHASE2
-
A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa)
NCT02486432 ·Status: COMPLETED ·Phase: PHASE1