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This trial will evaluate the effects of Lu AF28996 in adults with Parkinson's disease (PD) experiencing motor fluctuations despite optimized non-invasive symptomatic treatment. These are individuals with PD who take medications to control movement symptoms, such as slowness, stiffness, and tremor, but still experience periods of time when their medication does not adequately control their motor symptoms. Some may also experience dyskinesia (other type of involuntary movements) as a side effect of their PD medications. The main goal of the trial is to learn whether adding Lu AF28996 to participants' optimized PD medications will help extending the time they spend with their movement symptoms being well-controlled and without bothersome dyskinesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AF28996 | Experimental | Participants will receive Lu AF28996 as add-on to concomitant PD medications for up to Week 23. |
|
| Placebo | Placebo Comparator | Participants will receive Lu AF28996 matching placebo as add-on to concomitant PD medications for up to Week 23. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF28996 | Drug | Lu AF28996 will be administered orally per schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 19 in Daily Good ON Time Based on the Participant's Hauser Diary Entries | Baseline, Week 19 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 19 in Daily OFF Time Based on Participant's Hauser Diary Entries | Baseline, Week 19 | |
| Change From Baseline to Week 19 in Daily ON Time With Troublesome Dyskinesia Based on Participant's Hauser Diary Entries in Participants Reporting ≥1 Hour of Daily ON Time With Troublesome Dyskinesia at Baseline |
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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 | H. Lundbeck A/S | Study Director |
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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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| Placebo | Drug | Placebo matching to Lu AF28996 will be administered orally per schedule specified in the arm description. |
|
| Baseline, Week 19 |
| Change From Baseline to Week 19 in Participant's Unified Dyskinesia Rating Scale (UDysRS) Total Score in Participants Reporting ≥1 Hour of Daily ON Time With Troublesome Dyskinesia at Baseline | Baseline, Week 19 |
| Participant's Achievement at Week 19 of a Reduction in Daily OFF Time, Defined as >1.5 Hour/Day Reduction | Week 19 |
| Participant's Achievement at Week 19 of an Increase in Daily Good ON Time >1.5 Hour/Day | Week 19 |
| Participant's Achievement at Week 19 of a Reduction in Both Daily ON Time With Troublesome Dyskinesia AND in OFF time in Participants Reporting ≥1 Hour of Daily ON Time With Troublesome Dyskinesia at Baseline | Week 19 |
| Change From Baseline to Week 19 in Clinical Global Impression - Severity of Illness (CGI-S) Score | Baseline, Week 19 |
| Change From Baseline to Week 19 in Participant's Movement Disorder Society-Unified Parkinson's Disease-Rating Scale (MDS-UPDRS) Part III Score | Baseline, Week 19 |
| Change From Baseline to Week 19 in Participant's Movement Disorders Society Non-Motor Rating Scale (MDS-NMS) Domain Scores and Total Score | Baseline, Week 19 |
| Change From Baseline to Week 19 in Participant's Parkinson's Disease Sleep Scale Version 2 (PDSS-2) Total Score | Baseline, Week 19 |
| Change From Baseline to Week 19 in Participant's MDS-UPDRS Part IV (B) (Questions 4.1, 4.2, 4.3, 4.4 Item Scores), and Part IV Score | Baseline, Week 19 |
| Change From Baseline to Week 19 in Participant's MDS-UPDRS Total Score | Baseline, Week 19 |
| Change From Baseline to Week 19 in Participant's MDS-UPDRS Part I Score | Baseline, Week 19 |
| Change From Baseline to Week 19 in Participant's MDS-UPDRS Part II Score | Baseline, Week 19 |
| Change From Baseline to Week 19 in Participant's Parkinson's Disease Questionnaire-39 (PDQ-39) Score | Baseline, Week 19 |
| Change From Baseline to Week 19 in Participant's EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) Visual Analogue Scale Score | Baseline, Week 19 |
| Change From Baseline to Week 19 in Daily Oral Levodopa (mg) | Baseline, Week 19 |
| Change From Baseline to Week 19 in Levodopa-equivalent Dose (LED) | Baseline, Week 19 |
| Change From Baseline to Week 19 in Total Levodopa-equivalent Daily Dose (LEDD) | Baseline, Week 19 |
| Patient Global Impression of Change (PGI-C) Score at Week 19 | Week 19 |
| Plasma Concentrations of Lu AF28996 and Metabolites | Weeks 7 and 15 |
| Change From Baseline to Week 19 in Daily ON Time With Troublesome Dyskinesia Based on Participant's Hauser Daily Entries | Baseline, Week 19 |
| Change From Baseline to Week 19 in Daily ON Time Without Troublesome Dyskinesia Based on Participant's Hauser Daily Entries | Baseline, Week 19 |
| Change From Baseline to Week 19 in Daily ON Time With Non-troublesome Dyskinesia Based on Participant's Hauser Daily Entries | Baseline, Week 19 |
| Change From Baseline to Week 19 in Participant's UDysRS Total Score and Combined Partial Scores of Part 1 + Part 2, Part 3 + Part 4, and Part 1 + Part 3 + Part 4, in Participants With UDysRS Total Score ≥20 at Baseline | Baseline, Week 19 |
| Number of Participants With Achievement of a Reduction in Daily ON Time With Troublesome Dyskinesia at Week 19 | Week 19 |
| Number of Participants With Achievement of No Worsening in Daily ON Time With Troublesome Dyskinesia at Week 19 | Week 19 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |