Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04322227
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Healthy Drug: Foliglurax 10 mg (treatment A) Drug: Foliglurax 30 mg (treatment B) Drug: Placebo (treatment C) Phase 1

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)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 23, 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Latency of EEG movement related desynchronization of the μ-oscillations [ Time Frame: From baseline to Day 7 in each Treatment Period ]
    Latency of μ-desynchronization ipsilateral and contralateral (in ms)

  2. Latency of EEG movement related synchronization of the beta-oscillations [ Time Frame: From baseline to Day 7 in each Treatment Period ]
    Latency of beta-rebound ipsilateral and contralateral (in ms)

  3. Offset of EEG movement related synchronization of the beta-oscillations [ Time Frame: From baseline to Day 7 in each Treatment Period ]
    Offset of beta-rebound ipsilateral and contralateral (in ms)

  4. Latency of movement from cue measured by accelerometer [ Time Frame: From baseline to Day 7 in each Treatment Period ]
    Latency of movement from cue (in ms)

  5. Average power in u-desynchronization cluster measured by EEG [ Time Frame: From baseline to Day 7 in each Treatment Period ]
    Power in μ-desynchronization cluster ipsilateral and contralateral (in micro-volts squared)

  6. Average power in beta-rebound cluster measured by EEG [ Time Frame: From baseline to Day 7 in each Treatment Period ]
    Power in beta-rebound cluster ipsilateral and contralateral (in micro-volts squared)

  7. Power in the frequency domain of the greater tremor frequency [ Time Frame: From baseline to Day 7 in each Treatment Period ]
    Power in micro-volts squared



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322227


Contacts
Layout table for location contacts
Contact: Email contact via H. Lundbeck A/S +45 36301311 LundbeckClinicalTrials@Lundbeck.com

Locations
Layout table for location information
France
Biotrial Rennes Recruiting
Rennes, France, 35042
Contact: Email contact via H. Lundbeck A/S    +45 36301311    LundbeckClinicalTrials@Lundbeck.com   
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Layout table for investigator information
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
Layout table for additonal information
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT04322227    
Other Study ID Numbers: 18240A
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases