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

March 16, 2020 updated by: Prexton Therapeutics

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)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Universitätsklinik für Innere Medizin VI Innsbruck, Neurologisches Studienzentrum
  • France
      • Amiens, France, 80054
        • Centre Hospitalier Universitaire d'Amiens
      • Bayonne, France, 64100
        • Centre Hospitalier de la Cote Basque
      • Bobigny, France, 93009
        • Hôpital Avicenne APHP
      • Bron, France, 69500
        • Hôpital Pierre Wertheimer
      • Clermont-Ferrand, France, 63003
        • CHU Gabriel-Montpied
      • Grenoble, France, 38043
        • CHU Grenoble - Pôle Psychiatrie et Neurologie
      • Lille, France, 59037
        • CHRU - Hôpital Roger Salengro
      • Nice, France, 06002
        • CHU de Nice - Hopital Pasteur
      • Paris, France, 75013
        • Hôpital Pitié-Salpêtrière
      • Poitiers, France, 86000
        • CHU De Poitiers
      • Rouen, France, 76031
        • Hopital Universitaire
      • Saint-Herblain, France, 44805
        • CHU de Nantes - Hopital Nord Laennec
      • Strasbourg, France
        • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
      • Toulouse, France, 31059
        • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
  • Germany
      • Bad Homburg, Germany, 61348
        • Practice for Neurology, Psychiatry & Psychotherapy Dr. med. I. Schoell & colleagues
      • Berlin, Germany, 13088
        • St. Joseph-Krankenhaus Berlin-Weissensee
      • Erlangen, Germany, 91054
        • University Hospital Erlangen - Abteilung fur Molekulare Neurologie
      • Gera, Germany, 07551
        • Neurological Praxis
      • Jena, Germany, 07747
        • Am Klinikum 1 Jena
      • Kassel, Germany, 34128
        • Paracelsus-Elena-Klinik Kassel
      • Mühldorf, Germany
        • MVZ Kliniken Mühldorf a. Inn
  • Italy
      • Arcugnano, Italy, 36057
        • Villa Margherita
      • Chieti, Italy, 66100
        • Fondazione Universita G. D'Annunzio Centro Studi sull'invecchiamento Centro di Ricerca Clinica
      • Fisciano, Italy, 84084
        • Università degli studi di salerno
      • Messina, Italy, 98123
        • IRCCS Centro Neurolesi Bonino Pulejo
      • Milano, Italy, 20133
        • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero Di Santa Chiara
      • Roma, Italy, 00133
        • Policlinico Tor Vergata
      • Roma, Italy, 163
        • IRCCS San Raffaele Pisana
      • Roma, Italy, 185
        • Università degli studi di Roma "La Sapienza"
      • Rozzano, Italy, 20089
        • Humanitas Research Hospital
      • Venezia, Italy, 30126
        • IRCCS Fondazione Ospedale San Camillo (SC)
  • Spain
      • Barcelona, Spain, 8025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 8036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 8035
        • Hospital Universitario Vall d'Hebron
      • Elche, Spain, 3203
        • Hospital General Universitario de Elche
      • Sant Cugat del Vallès, Spain, 8195
        • Hospital Universitari General de Catalunya
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46010
        • Hospital Universitari i Politecnic La Fe
  • United Kingdom
      • Bury, United Kingdom, BL9 7TD
        • Fairfield General Hospital
      • London, United Kingdom, W6 8RF
        • Imperial College Healthcare NHS Trust - Charing Cross Hospital
      • Newcastle upon Tyne, United Kingdom, NE4 5PL
        • Clinical Ageing Research Unit, Campus for Ageing and Vitality
      • North Shields, United Kingdom, NE29 8NH
        • North Tyneside General Hospital
      • Plymouth, United Kingdom, PL6 8DH
        • Plymouth Hospitals NHS Trust - Derriford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to end of Treatment Period in the daily awake OFF time based on subject Hauser diary entries
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prexton Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2017

Primary Completion (Actual)

February 19, 2020

Study Completion (Actual)

March 2, 2020

Study Registration Dates

First Submitted

May 19, 2017

First Submitted That Met QC Criteria

May 19, 2017

First Posted (Actual)

May 22, 2017

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PXT-CL17-001
  • 18023A (Other Identifier: Lundbeck)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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