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Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients (AMBLED)

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ClinicalTrials.gov Identifier: NCT03162874
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Prexton Therapeutics

Study Description
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Brief Summary:
This will be a double-blind, randomised, placebo-controlled parallel-arm phase II proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing both end-of-dose wearing off and Levodopa-Induced Dyskinesia (LID)

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Placebo oral capsule Drug: PXT002331 - dose 1 Drug: PXT002331 - dose 2 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment With PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects With Parkinson's Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED)
Actual Study Start Date : July 4, 2017
Actual Primary Completion Date : February 19, 2020
Actual Study Completion Date : March 2, 2020

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: PLACEBO Drug: Placebo oral capsule
BID
Experimental: PXT002331 - 10mg Drug: PXT002331 - dose 1
Oral
Experimental: PXT002331 - 30mg Drug: PXT002331 - dose 2
Oral


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline to end of Treatment Period in the daily awake OFF time based on subject Hauser diary entries [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females diagnosed after the age of 30 years with idiopathic PD for at least 3 years
  • Disease severity of 2 to 4 on the modified Hoehn and Yahr scale when in the OFF state
  • Been treated with a stable regimen of levodopa-containing therapy
  • Subjects who are on a long-acting formulation of levodopa-containing therapy, including Apodespan PR (or equivalent), must be on a stable dose for at least 6 weeks prior to the first screening visit
  • Experienced motor fluctuations with wearing off over a period of at least 3 months prior to randomisation
  • Experienced LID over a period of at least 3 months prior to randomisation
  • Female subjects will be women of non-childbearing potential
  • Subjects must pass a Hauser diary concordance test
  • Subjects are able, with or without the help of a caregiver, to understand the purpose and risks of the study and provide signed and dated informed consent and authorisation to use confidential health information in accordance with national and local subject privacy regulations

Exclusion Criteria:

  • Subjects with atypical, secondary or drug-induced Parkinsonism
  • Subjects with a Mini-Mental State Examination (MMSE) score <25
  • Any known contraindication to the use of levodopa, including a history of malignant melanoma or a history of narrow-angle glaucoma.
  • Subjects who have had a clinically significant illness within 4 weeks of first dose, as determined by the Investigator.
  • Any advanced, severe or unstable disease (other than PD) that may interfere with the primary and secondary study outcome evaluations
  • Subjects who have undergone prior neurosurgical operation for PD or transcranial magnetic stimulation.
  • Subjects who are participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to the baseline visit.
  • Female subjects of childbearing potential
  • Subjects who are pregnant (as determined by positive serum pregnancy test at screening and/or baseline), breastfeeding or lactating.
  • Subjects who, in the opinion of the Investigator, should not participate in this study.
Contacts and Locations
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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): NCT03162874


Locations
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Sponsors and Collaborators
Prexton Therapeutics
More Information
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Responsible Party: Prexton Therapeutics
ClinicalTrials.gov Identifier: NCT03162874    
Other Study ID Numbers: PXT-CL17-001
18023A ( Other Identifier: Lundbeck )
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prexton Therapeutics:
Levodopa-Induced Dyskinesia (LID)
Wearing-off
Foliglurax
Parkinson's Disease
mGluR4 PAM
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases