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

NCT04322227 | Terminated Phase 1

• 1 other identifier: 18240A
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease; Healthy

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Healthy

EXPERIMENTAL

Drug: Foliglurax 10 mg (treatment A); Drug: Foliglurax 30 mg (treatment B); Drug: Placebo (treatment C)

PD

EXPERIMENTAL

Drug: Foliglurax 10 mg (treatment A); Drug: Foliglurax 30 mg (treatment B); Drug: Placebo (treatment C)

Interventions

Foliglurax 10 mg (treatment A) DRUG

Foliglurax 10 mg, (BID) capsules, orally

Healthy; PD

Foliglurax 30 mg (treatment B) DRUG

Foliglurax 30 mg, BID capsules, orally

Healthy; PD

Placebo (treatment C) DRUG

Placebo, BID capsules, orally

Healthy; PD

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

Biotrial Rennes

Rennes, 35042, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

foliglurax

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: March 26, 2020
• Study Start: January 23, 2020
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

FR (1)