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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04322227
• Other study ID #: 18240A
• Status: Terminated
• Phase: Phase 1
• Start date: January 23, 2020
• Est. completion date: May 30, 2020

Study information

• Verified date: July 2020
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Parkinson Disease

Intervention

Drug:
• Foliglurax 10 mg (treatment A)
Foliglurax 10 mg, (BID) capsules, orally
• Foliglurax 30 mg (treatment B)
Foliglurax 30 mg, BID capsules, orally
• Placebo (treatment C)
Placebo, BID capsules, orally

Locations

Country	Name	City	State
France	Biotrial Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Latency of movement from cue measured by accelerometer	Latency of movement from cue (in ms)	From baseline to Day 7 in each Treatment Period
Primary	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
Primary	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
Primary	Power in the frequency domain of the greater tremor frequency	Power in micro-volts squared	From baseline to Day 7 in each Treatment Period