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

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

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

Study Overview

• Status: Terminated
• Conditions: Healthy; Parkinson Disease
• Intervention / Treatment: Drug: Foliglurax 10 mg (treatment A); Drug: Foliglurax 30 mg (treatment B); Drug: Placebo (treatment C)

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35042
    • Biotrial Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy	Drug: Foliglurax 10 mg (treatment A); Foliglurax 10 mg, (BID) capsules, orally; Drug: Foliglurax 30 mg (treatment B); Foliglurax 30 mg, BID capsules, orally; Drug: Placebo (treatment C); Placebo, BID capsules, orally
Experimental: PD	Drug: Foliglurax 10 mg (treatment A); Foliglurax 10 mg, (BID) capsules, orally; Drug: Foliglurax 30 mg (treatment B); Foliglurax 30 mg, BID capsules, orally; Drug: Placebo (treatment C); Placebo, BID capsules, orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	From baseline to Day 7 in each Treatment Period

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2020
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 3, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 18240A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No