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Study termination due to efficacy results of another study
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The purpose of this study is to investigate effects of foliglurax on brain wave patterns (electric signals) in healthy subjects and in patients with PD
All Treatment Periods (P1 to P3) consist of 7 days of dosing (D1 to D7) with either:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | Experimental |
| |
| PD | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foliglurax 10 mg (treatment A) | Drug | Foliglurax 10 mg, (BID) capsules, orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Latency of EEG movement related desynchronization of the μ-oscillations | Latency of μ-desynchronization ipsilateral and contralateral (in ms) | From baseline to Day 7 in each Treatment Period |
| Latency of EEG movement related synchronization of the beta-oscillations | Latency of beta-rebound ipsilateral and contralateral (in ms) | From baseline to Day 7 in each Treatment Period |
| Offset of EEG movement related synchronization of the beta-oscillations | Offset of beta-rebound ipsilateral and contralateral (in ms) | From baseline to Day 7 in each Treatment Period |
| Latency of movement from cue measured by accelerometer | Latency of movement from cue (in ms) | From baseline to Day 7 in each Treatment Period |
| Average power in u-desynchronization cluster measured by EEG | Power in μ-desynchronization cluster ipsilateral and contralateral (in micro-volts squared) | From baseline to Day 7 in each Treatment Period |
| Average power in beta-rebound cluster measured by EEG | Power in beta-rebound cluster ipsilateral and contralateral (in micro-volts squared) | From baseline to Day 7 in each Treatment Period |
| Power in the frequency domain of the greater tremor frequency | Power in micro-volts squared |
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Inclusion Criteria:
Healthy subjects
Patients with PD
Exclusion criteria:
Other in- and exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotrial Rennes | Rennes | 35042 | France |
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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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| ID | Term |
|---|---|
| C000730045 | foliglurax |
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| Foliglurax 30 mg (treatment B) |
| Drug |
Foliglurax 30 mg, BID capsules, orally |
|
| Placebo (treatment C) | Drug | Placebo, BID capsules, orally |
|
| From baseline to Day 7 in each Treatment Period |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |