ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease
Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ADX48621 in the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease
1 other identifier
interventional
83
4 countries
25
Brief Summary
The primary objective of the study is to evaluate the safety and tolerability of ADX48621 in Parkinson's disease patients following four weeks of dosing. The secondary objectives of the study include the evaluation of the efficacy of ADX48621 compared with placebo in reducing levodopa induced dyskinesia in patients with Parkinson's; the evaluation of the effect of ADX48621 on symptoms of Parkinson's disease and patient ability to function, and the evaluation of the effect of coadministration of ADX48621 on L-dopa efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2011
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 4, 2011
CompletedFirst Posted
Study publicly available on registry
April 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedJuly 16, 2012
July 1, 2012
10 months
April 4, 2011
July 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with abnormal safety and tolerability assessment parameters
Physical and neurological examination, heart rate and blood pressure, 12-lead ECG, hematology and biochemistry assessments, use of concomitant medications, adverse events and serious adverse events.
4 weeks
Secondary Outcomes (3)
Dyskinesia severity score measured by mAIMS
4 weeks
Change in Parkinson's disease severity
4 weeks
Patient-rated and clinician-rated global impression of change in dyskinesia and Parkinson's disease
4 weeks
Study Arms (2)
ADX48621
EXPERIMENTALADX48621 Matching Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- outpatient with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBCDC)
- experiences moderately disabling dyskinesia (screening visit UPDRS 33 score≥2)
- has an mAIMS score at baseline ≥ 7 with a score ≥ 3 in at least one body area
You may not qualify if:
- surgical treatment for Parkinson's disease (e.g. Deep Brain Stimulation, within the last year or planned during the study)
- unstable co-existing psychiatric disease including cognitive impairment that, according to the Investigator, could interfere with the conduct of the study
- has a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study.
- is 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Addex Investigator Site
Birmingham, Alabama, 35233, United States
Addex Investigator Site
Phoenix, Arizona, 85013, United States
Addex Investigator Site
La Jolla, California, 92037, United States
Addex Investigator Site
Los Angeles, California, 90033, United States
Addex Investigator Site
Sunnyvale, California, 94085, United States
Addex Investigator Site
New Haven, Connecticut, 06510, United States
Addex Investigator Site
Boca Raton, Florida, 33612, United States
Addex Investigator Site
Tampa, Florida, 33606, United States
Addex Investigator Site
Chicago, Illinois, 60612, United States
Addex Investigator Site
Southfield, Michigan, 48034, United States
Addex Investigator Site
Commack, New York, 11725, United States
Addex Investigator Site
Portland, Oregon, 97239, United States
Addex Investigator Site
Kirkland, Washington, 98034, United States
Addex Investigator Site
Innsbruck, Austria
Addex Investigator Site
Bordeaux, France
Addex Investigator Site
Clermont-Ferrand, France
Addex Investigator Site
Nantes, France
Addex Investigator Site
Paris, France
Addex Investigator Site
Toulouse, France
Addex Investigator Site
Bochum, Germany
Addex Investigator Site
Hanau, Germany
Addex Investigator Site
Hanover, Germany
Addex Investigator Site
Kassel, Germany
Addex Investigator Site
Marburg, Germany
Addex Investigator Site
Munich, Germany
Related Publications (1)
McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.
PMID: 31356217DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Addex Pharma
Addex Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2011
First Posted
April 15, 2011
Study Start
April 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
July 16, 2012
Record last verified: 2012-07