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

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ClinicalTrials.gov Identifier: NCT04857359
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : May 20, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Dyskinesia, Drug-Induced Dyskinesias Drug: Dipraglurant Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 6, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

Arm Intervention/treatment
Experimental: Dipraglurant TID Drug: Dipraglurant
Oral 50mg and 100mg tablet
Other Name: ADX48621

Placebo Comparator: Placebo TID Drug: Placebo
Oral matching placebo tablet




Primary Outcome Measures :
  1. Change from baseline on the Unified Dyskinesia Rating Scale (UDysRS) total score [ Time Frame: 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 :
  1. Change from baseline in ON time without troublesome dyskinesia based on a standardized PD diary [ Time Frame: 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.

  2. Change from baseline in OFF time based on a standardized PD diary [ Time Frame: 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.



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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857359


Contacts
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Contact: Study Director 877-409-1775 addex@druginfo.com

Locations
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Sponsors and Collaborators
Addex Pharma S.A.
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Responsible Party: Addex Pharma S.A.
ClinicalTrials.gov Identifier: NCT04857359    
Other Study ID Numbers: ADX48621-301
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Addex Pharma S.A.:
Parkinson's disease
Dyskinesia
Levodopa-induced Dyskinesia
Additional relevant MeSH terms:
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Parkinson Disease
Dyskinesias
Dyskinesia, Drug-Induced
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Neurologic Manifestations
Neurotoxicity Syndromes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning