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

Primary Purpose

Parkinson Disease, Healthy

Status

Terminated

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

Foliglurax 10 mg (treatment A)

Foliglurax 30 mg (treatment B)

Placebo (treatment C)

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Biotrial Rennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Healthy

Arm Description

Outcomes

Primary Outcome Measures

Latency of EEG movement related desynchronization of the μ-oscillations

Latency of μ-desynchronization ipsilateral and contralateral (in ms)

Latency of EEG movement related synchronization of the beta-oscillations

Latency of beta-rebound ipsilateral and contralateral (in ms)

Offset of EEG movement related synchronization of the beta-oscillations

Offset of beta-rebound ipsilateral and contralateral (in ms)

Latency of movement from cue measured by accelerometer

Latency of movement from cue (in ms)

Average power in u-desynchronization cluster measured by EEG

Power in μ-desynchronization cluster ipsilateral and contralateral (in micro-volts squared)

Average power in beta-rebound cluster measured by EEG

Power in beta-rebound cluster ipsilateral and contralateral (in micro-volts squared)

Power in the frequency domain of the greater tremor frequency

Power in micro-volts squared

Secondary Outcome Measures

Full Information

NCT ID

NCT04322227

First Posted

January 29, 2020

Last Updated

July 3, 2020

Sponsor

H. Lundbeck A/S

1. Study Identification

Unique Protocol Identification Number

NCT04322227

Brief Title

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

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Terminated

Why Stopped

Study termination due to efficacy results of another study

Study Start Date

January 23, 2020 (Actual)

Primary Completion Date

May 30, 2020 (Actual)

Study Completion Date

May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease, Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Foliglurax 10 mg (treatment A)

Intervention Description

Foliglurax 10 mg, (BID) capsules, orally

Intervention Type

Drug

Intervention Name(s)

Foliglurax 30 mg (treatment B)

Intervention Description

Foliglurax 30 mg, BID capsules, orally

Intervention Type

Drug

Intervention Name(s)

Placebo (treatment C)

Intervention Description

Placebo, BID capsules, orally

Primary Outcome Measure Information:

Title

Latency of EEG movement related desynchronization of the μ-oscillations

Description

Latency of μ-desynchronization ipsilateral and contralateral (in ms)

Time Frame