Study Investigating Effects of Foliglurax in Patients With Parkinson's Disease (PD) and Healthy Subjects

Phase 1

Terminated

• Conditions: Parkinson Disease; Healthy
• Interventions: Drug: Foliglurax 10 mg (treatment A); Drug: Foliglurax 30 mg (treatment B); Drug: Placebo (treatment C)

• Registration Number: NCT04322227
• Lead Sponsor: H. Lundbeck A/S

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)

Study Timeline

• Study Start: 2020-01-23
• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-26
• Primary Completion: 2020-05-30
• Study Completion: 2020-05-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-03
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PD	Foliglurax 30 mg (treatment B)	-
PD	Foliglurax 10 mg (treatment A)	-
Healthy	Foliglurax 10 mg (treatment A)	-
Healthy	Foliglurax 30 mg (treatment B)	-
Healthy	Placebo (treatment C)	-
PD	Placebo (treatment C)	-

Primary Outcome Measures

Name	Time	Method
Power in the frequency domain of the greater tremor frequency	From baseline to Day 7 in each Treatment Period	Power in micro-volts squared
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 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)
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)

Trial Locations

Locations (1)

Biotrial Rennes; 🇫🇷 Rennes, France