CLINICAL TRIALS PROFILE FOR DIPRAGLURANT
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Clinical Trials for Dipraglurant
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT01336088 ↗ | ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease | Completed | Addex Pharma S.A. | Phase 2 | 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. |
| NCT02447640 ↗ | PET Imaging Study to Evaluate the mGlu5r Occupancy Following ADX48621 (Dipraglurant) Administration | Completed | Addex Pharma S.A. | Phase 1 | This is an open label study, non-randomized, positron emission tomography (PET)study investigating mGlu5 receptor occupancy after single or two oral dosing of ADX48621 in healthy subjects using [18F]-FPEB as the radiotracer. |
| NCT02447640 ↗ | PET Imaging Study to Evaluate the mGlu5r Occupancy Following ADX48621 (Dipraglurant) Administration | Completed | Johns Hopkins University | Phase 1 | This is an open label study, non-randomized, positron emission tomography (PET)study investigating mGlu5 receptor occupancy after single or two oral dosing of ADX48621 in healthy subjects using [18F]-FPEB as the radiotracer. |
| NCT04857359 ↗ | Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy | Recruiting | Addex Pharma S.A. | Phase 2/Phase 3 | 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. |
| NCT05027997 ↗ | Exploratory Study of Dipraglurant (ADX48621) for the Treatment of Patients With Blepharospasm | Recruiting | Addex Pharma S.A. | Phase 2 | This study is designed to assess the safety and tolerability of dipraglurant in patients with blepharospasm (BSP) (randomized 1:1:1 to receive dipraglurant 50 mg, 100 mg or placebo) and explore the efficacy of 50 mg and 100 mg immediate release tablets (versus placebo) on the severity and frequency of BSP signs and symptoms using objective measures, clinical ratings and patient reported outcomes. |
| NCT05116813 ↗ | Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy | Recruiting | Addex Pharma S.A. | Phase 2/Phase 3 | This open-label study is designed to assess the long-term safety and tolerability of dipraglurant in PD patients for up to 52 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day) for patients that have completed an Addex sponsored double-blind clinical trial of dipraglurant. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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