ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT01336088|
Recruitment Status : Completed
First Posted : April 15, 2011
Last Update Posted : July 16, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: ADX48621 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Other Name: Dipraglurant
|Placebo Comparator: ADX48621 Matching Placebo||
- Number of patients with abnormal safety and tolerability assessment parameters [ Time Frame: 4 weeks ]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.
- Dyskinesia severity score measured by mAIMS [ Time Frame: 4 weeks ]
- Change in Parkinson's disease severity [ Time Frame: 4 weeks ]Patient diary at weeks 1, 2, 3 and 4, UPDRS Part III at weeks 2 and 4, UPDRS total score at week 4
- Patient-rated and clinician-rated global impression of change in dyskinesia and Parkinson's disease [ Time Frame: 4 weeks ]
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): NCT01336088
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|Study Director:||Addex Pharma||Addex Pharma|