ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease
NCT ID: NCT01336088
Last Updated: 2012-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
83 participants
INTERVENTIONAL
2011-04-30
2012-02-29
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ADX48621
ADX48621
oral administration
ADX48621 Matching Placebo
Placebo
oral administration
Interventions
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ADX48621
oral administration
Placebo
oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
30 Years
75 Years
ALL
No
Sponsors
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Addex Pharma S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Addex Pharma
Role: STUDY_DIRECTOR
Addex Pharma
Locations
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Addex Investigator Site
Birmingham, Alabama, United States
Addex Investigator Site
Phoenix, Arizona, United States
Addex Investigator Site
La Jolla, California, United States
Addex Investigator Site
Los Angeles, California, United States
Addex Investigator Site
Sunnyvale, California, United States
Addex Investigator Site
New Haven, Connecticut, United States
Addex Investigator Site
Boca Raton, Florida, United States
Addex Investigator Site
Tampa, Florida, United States
Addex Investigator Site
Chicago, Illinois, United States
Addex Investigator Site
Southfield, Michigan, United States
Addex Investigator Site
Commack, New York, United States
Addex Investigator Site
Portland, Oregon, United States
Addex Investigator Site
Kirkland, Washington, 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
Countries
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References
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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.
Other Identifiers
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ADX48621-201
Identifier Type: -
Identifier Source: org_study_id