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Status:

TERMINATED

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

Lead Sponsor:

H. Lundbeck A/S

Conditions:

Parkinson Disease

Healthy

Eligibility:

All Genders

50-70 years

Phase:

PHASE1

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)

Eligibility Criteria

Inclusion

  • 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

    Key Trial Info

    Start Date :

    January 23 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 30 2020

    Estimated Enrollment :

    6 Patients enrolled

    Trial Details

    Trial ID

    NCT04322227

    Start Date

    January 23 2020

    End Date

    May 30 2020

    Last Update

    July 7 2020

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Biotrial Rennes

    Rennes, France, 35042