Healthy, Parkinson Disease
Conditions
Brief summary
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
Detailed description
All Treatment Periods (P1 to P3) consist of 7 days of dosing (D1 to D7) with either: * 10 mg foliglurax bis in die (BID) (treatment A) * 30 mg foliglurax BID (treatment B) * Placebo BID (treatment C)
Interventions
DRUGFoliglurax 10 mg (treatment A)
Foliglurax 10 mg, (BID) capsules, orally
DRUGFoliglurax 30 mg (treatment B)
Foliglurax 30 mg, BID capsules, orally
Placebo, BID capsules, orally
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy subjects * The subject has an acceptable resting EEG at the Screening Visit, as judged by the investigator * The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests. Patients with PD * The patient has an acceptable resting EEG performed at the screening period, as judged by the investigator. * The patient is, in the opinion of the investigator, fit for enrolment in the study based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests. * The patient has been diagnosed with idiopathic PD for ≥3 years, with a current disease severity of 2 to 4 on the modified Hoehn and Yahr scale in the 'off' state. * The patient has dyskinesia that is not too severe to cause discomfort for the patient during the EEG assessments
Exclusion criteria
* The subject has taken disallowed medication \<1 week prior to the first dose of Investigational Medicinal Product (IMP) or \<5 half-lives prior to the Screening Visit for any medication taken. * The subject has significant alcohol consumption * The subject has taken any investigational medicinal product \<3 months prior to the first dose of IMP. * The subjects has a known genetic disorder of human UDPglucoronosyltransferase * The subject is pregnant or breastfeeding. Other in- and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Latency of EEG movement related desynchronization of the μ-oscillations | From baseline to Day 7 in each Treatment Period | Latency of μ-desynchronization ipsilateral and contralateral (in ms) |
| Latency of EEG movement related synchronization of the beta-oscillations | From baseline to Day 7 in each Treatment Period | Latency of beta-rebound ipsilateral and contralateral (in ms) |
| Offset of EEG movement related synchronization of the beta-oscillations | From baseline to Day 7 in each Treatment Period | Offset of beta-rebound ipsilateral and contralateral (in ms) |
| Latency of movement from cue measured by accelerometer | From baseline to Day 7 in each Treatment Period | Latency of movement from cue (in ms) |
| Average power in u-desynchronization cluster measured by EEG | From baseline to Day 7 in each Treatment Period | Power in μ-desynchronization cluster ipsilateral and contralateral (in micro-volts squared) |
| Average power in beta-rebound cluster measured by EEG | From baseline to Day 7 in each Treatment Period | Power in beta-rebound cluster ipsilateral and contralateral (in micro-volts squared) |
| Power in the frequency domain of the greater tremor frequency | From baseline to Day 7 in each Treatment Period | Power in micro-volts squared |
Countries
France
Outcome results
None listed