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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
157

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 19, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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