Clinical trial NCT04322227: Study Investigating Effects of Foliglurax in Patients With Parkinson's Disease (PD) and Healthy Subjects
Official title: Interventional, Randomized, Double-blind, Placebo-controlled Three-way Crossover Study Investigating the Pharmacodynamic Effects of Two Doses of Foliglurax Using Electroencephalography in Patients With Parkinson's Disease and in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Parkinson Disease
Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2020-03-26
Enrollment: 6
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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)

Eligibility criteria: 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 exclusion criteria may apply

Primary outcomes:
measure: Latency of EEG movement related desynchronization of the μ-oscillations
timeFrame: From baseline to Day 7 in each Treatment Period
measure: Latency of EEG movement related synchronization of the beta-oscillations
timeFrame: From baseline to Day 7 in each Treatment Period
measure: Offset of EEG movement related synchronization of the beta-oscillations
timeFrame: From baseline to Day 7 in each Treatment Period
measure: Latency of movement from cue measured by accelerometer
timeFrame: From baseline to Day 7 in each Treatment Period
measure: Average power in u-desynchronization cluster measured by EEG
timeFrame: From baseline to Day 7 in each Treatment Period
measure: Average power in beta-rebound cluster measured by EEG
timeFrame: From baseline to Day 7 in each Treatment Period
measure: Power in the frequency domain of the greater tremor frequency
timeFrame: From baseline to Day 7 in each Treatment Period
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Biotrial Rennes
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: