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The purpose of this study is to investigate the safety of Lu AF28996, how well it is tolerated and what the body does to the drug in participants with Parkinson's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AF28996 | Experimental | Participants will receive oral doses of Lu AF28996 twice daily (BID) as add-on to the participant's usual PD treatment (levodopa and allowed PD medications) during the Up-titration treatment period, whereafter the participants will initiate down-titration of Lu AF28996. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF28996 | Drug | Capsule administered orally per schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 60 days | |
| Area Under the Plasma Concentration-time Curve From Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AF28996 | Days 1, 21 or 31, and 41 | |
| Maximum Observed Plasma Concentration (Cmax) of Lu AF28996 | Days 1, 21 or 31, and 41 | |
| Time to Reach Cmax (Tmax) of Lu AF28996 | Days 1, 21 or 31, and 41 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion and exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Email contact via H. Lundbeck A/S | Contact | +45 36301311 | HQ_Medinfo@Lundbeck.com |
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Capital Medical University | Beijing | 100053 | China | |||
| Beijing Tiantan Hospital, Capital Medical University |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Beijing |
| 100070 |
| China |
| West China Hospital, Sichuan University | Chengdu | 610041 | China |
| Huashan Hospital, Fudan University | Shanghai | 200040 | China |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |