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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)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Prexton Therapeutics
Sponsor:
Information provided by (Responsible Party):
Prexton Therapeutics
ClinicalTrials.gov Identifier:
NCT03162874
First received: May 19, 2017
Last updated: September 12, 2017
Last verified: May 2017
  Purpose
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 Intervention Phase
Parkinson Disease Drug: Placebo oral capsule Drug: PXT002331 - dose 1 Drug: PXT002331 - dose 2 Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Prexton Therapeutics:

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

Estimated Enrollment: 165
Actual Study Start Date: July 4, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 15, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: PLACEBO Drug: Placebo oral capsule
BID
Experimental: PXT002331 - 10mg Drug: PXT002331 - dose 1
Oral
Experimental: PXT002331 - 30mg Drug: PXT002331 - dose 2
Oral

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03162874

Contacts
Contact: TRAN, MSc +41227069010 PXT-CL17-001@prextontherapeutics.com

Locations
Austria
Medizinische Universität Graz Not yet recruiting
Graz, Austria, 8036
Contact: Karoline Wenzel, MD         
Universitätsklinik für Innere Medizin VI Innsbruck, Neurologisches Studienzentrum Recruiting
Innsbruck, Austria, 6020
Contact: Klaus Seppi, MD         
France
Centre Hospitalier Universitaire d'Amiens Not yet recruiting
Amiens, France, 80054
Contact: Pierre Krystowiak, MD         
Centre Hospitalier de la Côte Basque Not yet recruiting
Bayonne, France, 64100
Contact: Stephanie Bannier, MD         
Hôpital Pierre Wertheimer Not yet recruiting
Bron, France, 69500
Contact: Stephane Thobois, MD         
CHU Gabriel-Montpied Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Franck Durif, MD         
CHRU - Hôpital Roger Salengro Not yet recruiting
Lille, France, 59037
Contact: Luc Defebvre, MD         
CHU de Nice - Hôpital Pasteur Not yet recruiting
Nice, France, 06002
Contact: Caroline Bayreuther Giordana, MD         
Hopital Pitie-Salpetriere Not yet recruiting
Paris, France, 75013
Contact: Jean-Christophe Corvol, MD         
CHU de Poitiers Not yet recruiting
Poitiers, France, 86000
Contact: Luc Houeto, MD         
CHU de Nantes - Hôpital Nord Laennec Not yet recruiting
Saint-Herblain, France, 44805
Contact: Philippe Damier, MD         
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan Not yet recruiting
Toulouse, France, 31059
Contact: Olivier Rascol, MD         
Germany
St. Joseph-Krankenhaus Berlin-Weissensee Not yet recruiting
Berlin, Germany, 13088
Contact: Thomas Mueller, MD         
MVZ Kliniken Mühldorf a. Inn Not yet recruiting
Mühldorf, Germany
Contact: Johannes Schwarz, MD         
Italy
IRCCS San Raffaele Pisana Recruiting
Roma, Italy, 163
Contact: Fabrizio Stocchi, MD         
Spain
Hospital de la Santa Creu i Sant Pau Not yet recruiting
Barcelona, Spain, 8025
Contact: Jaime Kulisevsky Bojarski, MD         
Hospital Universitario Vall d'Hebron Not yet recruiting
Barcelona, Spain, 8035
Contact: Jorge Hernandez Vara, MD         
Hospital Clínic de Barcelona Not yet recruiting
Barcelona, Spain, 8036
Contact: Maria Jose Marti Domenech, MD         
Policlinica Gipuzkoa - Centro de Investigacion Parkinson (CIP) Not yet recruiting
Donostia / San Sebastián, Spain, 20014
Contact: Gurutz Linazasoro Cristobal, MD         
Hospital General Universitario de Elche Not yet recruiting
Elche, Spain, 3203
Contact: Maria Alvarez Sauco, MD         
Hospital General Universitario Gregorio Marañón Not yet recruiting
Madrid, Spain, 28007
Contact: Francisco Grandas Perez, MD         
Hospital Universitari General de Catalunya Not yet recruiting
Sant Cugat del Vallès, Spain, 8195
Contact: Ernest Balaguer Martinez, MD         
Hospital Universitario Virgen del Rocío Not yet recruiting
Sevilla, Spain, 41013
Contact: Pablo MIR RIVERA, MD         
Hospital Universitari i Politècnic La Fe Not yet recruiting
Valencia, Spain, 46010
Contact: Irene Martinez Torres, MD         
United Kingdom
Fairfield General Hospital Not yet recruiting
Bury, United Kingdom, BL9 7TD
Contact: Jason Raw, MD         
Imperial College Healthcare NHS Trust - Charing Cross Hospital Not yet recruiting
London, United Kingdom, W6 8RF
Contact: Sophie Molloy, MD         
Clinical Ageing Research Unit, Campus for Ageing and Vitality Not yet recruiting
Newcastle upon Tyne, United Kingdom, NE4 5PL
Contact: Nicola Pavese, MD         
North Tyneside General Hospital Not yet recruiting
North Shields, United Kingdom, NE29 8NH
Contact: Richard Walker, MD         
Plymouth Hospitals NHS Trust - Derriford Hospital Not yet recruiting
Plymouth, United Kingdom, PL6 8DH
Contact: Camille Carroll, MD         
Sponsors and Collaborators
Prexton Therapeutics
  More Information

Responsible Party: Prexton Therapeutics
ClinicalTrials.gov Identifier: NCT03162874     History of Changes
Other Study ID Numbers: PXT-CL17-001
Study First Received: May 19, 2017
Last Updated: September 12, 2017

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:
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

ClinicalTrials.gov processed this record on September 21, 2017