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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 : Recruiting
First Posted : May 22, 2017
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Prexton Therapeutics

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 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
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

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




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 ]


Information from the National Library of Medicine

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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.

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


Contacts
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Contact: TRAN, MSc +41227069010 AMBLED@lundbeck.com

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Locations
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Austria
Medizinische Universität Graz Recruiting
Graz, Austria, 8036
Contact: Petra MD Katschnig-Winter, MD         
Universitätsklinik für Innere Medizin VI Innsbruck, Neurologisches Studienzentrum Recruiting
Innsbruck, Austria, 6020
Contact: Klaus Seppi, MD         
France
Centre Hospitalier Universitaire d'Amiens Recruiting
Amiens, France, 80054
Contact: Pierre Krystowiak, MD         
Centre Hospitalier de la Côte Basque Recruiting
Bayonne, France, 64100
Contact: Stephanie Bannier, MD         
Hôpital Avicenne APHP Recruiting
Bobigny, France, 93009
Contact: Bertrand DEGOS, MD         
Hôpital Pierre Wertheimer Recruiting
Bron, France, 69500
Contact: Stephane Thobois, MD         
CHU Gabriel-Montpied Recruiting
Clermont-Ferrand, France, 63003
Contact: Franck Durif, MD         
CHU Grenoble - Pôle Psychiatrie et Neurologie Recruiting
Grenoble, France, 38043
Contact: Elena MORO, MD         
CHRU - Hôpital Roger Salengro Recruiting
Lille, France, 59037
Contact: Luc Defebvre, MD         
CHU de Nice - Hôpital Pasteur Recruiting
Nice, France, 06002
Contact: Caroline Bayreuther Giordana, MD         
Hopital Pitie-Salpetriere Recruiting
Paris, France, 75013
Contact: Jean-Christophe Corvol, MD         
CHU de Poitiers Recruiting
Poitiers, France, 86000
Contact: Luc Houeto, MD         
Hôpital Universitaire Recruiting
Rouen, France, 76031
Contact: David MALTETE, MD         
CHU de Nantes - Hôpital Nord Laennec Recruiting
Saint-Herblain, France, 44805
Contact: Philippe Damier, MD         
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan Recruiting
Toulouse, France, 31059
Contact: Olivier Rascol, MD         
Germany
Practice for Neurology, Psychiatry & Psychotherapy Dr. med. I. Schoell & colleagues Recruiting
Bad Homburg, Germany, 61348
Contact: Irma SCHOELL, MD         
St. Joseph-Krankenhaus Berlin-Weissensee Recruiting
Berlin, Germany, 13088
Contact: Thomas Mueller, MD         
University Hospital Erlangen - Abteilung fur Molekulare Neurologie Recruiting
Erlangen, Germany, 91054
Contact: Zacharias KOHL, MD         
Neurological Praxis Recruiting
Gera, Germany, 07551
Contact: Christian OEHLWEIN, MD         
Am Klinikum 1 Jena Recruiting
Jena, Germany, 07747
Contact: Tino PRELL, MD         
Paracelsus-Elena-Klinik Kassel Recruiting
Kassel, Germany, 34128
Contact: Claudia Trenkwalder, MD         
MVZ Kliniken Mühldorf a. Inn Recruiting
Mühldorf, Germany
Contact: Johannes Schwarz, MD         
Italy
Villa Margherita Recruiting
Arcugnano, Italy, 36057
Contact: Giampietro NORDERA, MD         
Fondazione Universita G. D'Annunzio Centro Studi sull'invecchiamento Centro di Ricerca Clinica Recruiting
Chieti, Italy, 66100
Contact: Marco ONOFRJ, MD         
Universita degli Studi di Salerno Recruiting
Fisciano, Italy, 84084
Contact: Paolo BARONE, MD         
Ospedale Della Misericordia Grosseto Recruiting
Grosseto, Italy, 58100
Contact: Roberto MARCONI, MD         
IRCCS Centro Neurolesi Bonino Pulejo Recruiting
Messina, Italy, 98123
Contact: Placido BRAMANTI, MD         
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Recruiting
Milano, Italy, 20133
Contact: Paolo SOLIVERI, MD         
IRCCS Fondazione Istituto Neurologico Nazionale Casimiro Mondino Recruiting
Pavia, Italy, 27100
Contact: Claudio PACCHETTI, MD         
Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara Recruiting
Pisa, Italy, 56126
Contact: Ubaldo BONUCCELLI, MD         
Policlinico Tor Vergata Recruiting
Roma, Italy, 00133
Contact: Alessandro STEFANI, MD         
IRCCS San Raffaele Pisana Recruiting
Roma, Italy, 163
Contact: Fabrizio Stocchi, MD         
Università degli Studi di Roma "La Sapienza" Recruiting
Roma, Italy, 185
Contact: Giovanni FABBRINI, MD         
Humanitas Research Hospital Recruiting
Rozzano, Italy, 20089
Contact: Alberto ALBANESE, MD         
IRCCS Fondazione Ospedale San Camillo (SC) Recruiting
Venezia, Italy, 30126
Contact: Elisabetta Gasparoli, MD         
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 8025
Contact: Jaime Kulisevsky Bojarski, MD         
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 8035
Contact: Jorge Hernandez Vara, MD         
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 8036
Contact: Maria Jose Marti Domenech, MD         
Policlinica Gipuzkoa - Centro de Investigacion Parkinson (CIP) Recruiting
Donostia / San Sebastián, Spain, 20014
Contact: Gurutz Linazasoro Cristobal, MD         
Hospital General Universitario de Elche Recruiting
Elche, Spain, 3203
Contact: Maria Alvarez Sauco, MD         
Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact: Francisco Grandas Perez, MD         
Hospital Universitari General de Catalunya Recruiting
Sant Cugat del Vallès, Spain, 8195
Contact: Ernest Balaguer Martinez, MD         
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain, 41013
Contact: Pablo MIR RIVERA, MD         
Hospital Universitari i Politècnic La Fe Recruiting
Valencia, Spain, 46010
Contact: Irene Martinez Torres, MD         
United Kingdom
Fairfield General Hospital Recruiting
Bury, United Kingdom, BL9 7TD
Contact: Jason Raw, MD         
Imperial College Healthcare NHS Trust - Charing Cross Hospital Recruiting
London, United Kingdom, W6 8RF
Contact: Sophie Molloy, MD         
Clinical Ageing Research Unit, Campus for Ageing and Vitality Recruiting
Newcastle upon Tyne, United Kingdom, NE4 5PL
Contact: Nicola Pavese, MD         
North Tyneside General Hospital Recruiting
North Shields, United Kingdom, NE29 8NH
Contact: Richard Walker, MD         
Plymouth Hospitals NHS Trust - Derriford Hospital Recruiting
Plymouth, United Kingdom, PL6 8DH
Contact: Camille Carroll, MD         
Sponsors and Collaborators
Prexton Therapeutics

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Responsible Party: Prexton Therapeutics
ClinicalTrials.gov Identifier: NCT03162874     History of Changes
Other Study ID Numbers: PXT-CL17-001
18023A ( Other Identifier: Lundbeck )
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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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
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs