ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT01336088

Run by

Addex Pharma S.A.

People needed

83

Starts

2011-04-01

Expected to finish

2012-02-01

Last updated by the study team

2012-07-16

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• Other protocol-defined inclusion and exclusion criteria may apply

Where it is running

• 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

Full record on ClinicalTrials.gov

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