Parkinson DiseasePhase 2AMBLEDNCT03162874
Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients
A Phase 2 study testing PXT002331 - dose 1 and PXT002331 - dose 2 in people with Parkinson Disease, run by Prexton Therapeutics at 45 sites in 6 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- PXT002331 - dose 1 and PXT002331 - dose 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 45 sitesin 6 countries
- Study dates
- 4 Jul 2017to 2 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
45 sites in 6 countries.
45 sites in 6 countries
France14 sites
Centre Hospitalier Universitaire d'Amiens
Amiens, 80054
Centre Hospitalier de la Côte Basque
Bayonne, 64100
Hôpital Avicenne APHP
Bobigny, 93009
Hôpital Pierre Wertheimer
Bron, 69500
CHU Gabriel-Montpied
Clermont-Ferrand, 63003
CHU Grenoble - Pôle Psychiatrie et Neurologie
Grenoble, 38043
CHRU - Hôpital Roger Salengro
Lille, 59037
CHU de Nice - Hôpital Pasteur
Nice, 06002
Hopital Pitie-Salpetriere
Paris, 75013
CHU de Poitiers
Poitiers, 86000
Hôpital Universitaire
Rouen, 76031
CHU de Nantes - Hôpital Nord Laennec
Saint-Herblain, 44805
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
Toulouse, 31059
Italy11 sites
Villa Margherita
Arcugnano, 36057
Fondazione Universita G. D'Annunzio Centro Studi sull'invecchiamento Centro di Ricerca Clinica
Chieti, 66100
Universita degli Studi di Salerno
Fisciano, 84084
IRCCS Centro Neurolesi Bonino Pulejo
Messina, 98123
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Milan, 20133
Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara
Pisa, 56126
Policlinico Tor Vergata
Roma, 00133
IRCCS San Raffaele Pisana
Roma, 163
Università degli Studi di Roma "La Sapienza"
Roma, 185
Humanitas Research Hospital
Rozzano, 20089
IRCCS Fondazione Ospedale San Camillo (SC)
Venezia, 30126
Germany7 sites
Practice for Neurology, Psychiatry & Psychotherapy Dr. med. I. Schoell & colleagues
Bad Homburg, 61348
St. Joseph-Krankenhaus Berlin-Weissensee
Berlin, 13088
University Hospital Erlangen - Abteilung fur Molekulare Neurologie
Erlangen, 91054
Neurological Praxis
Gera, 07551
Am Klinikum 1 Jena
Jena, 07747
Paracelsus-Elena-Klinik Kassel
Kassel, 34128
MVZ Kliniken Mühldorf a. Inn
Mühldorf
Spain7 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 8025
Hospital Universitario Vall d'Hebron
Barcelona, 8035
Hospital Clínic de Barcelona
Barcelona, 8036
Hospital General Universitario de Elche
Elche, 3203
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, 8195
Hospital Universitario Virgen del Rocío
Seville, 41013
Hospital Universitari i Politècnic La Fe
Valencia, 46010
United Kingdom5 sites
Fairfield General Hospital
Bury, BL9 7TD
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, W6 8RF
Clinical Ageing Research Unit, Campus for Ageing and Vitality
Newcastle upon Tyne, NE4 5PL
North Tyneside General Hospital
North Shields, NE29 8NH
Plymouth Hospitals NHS Trust - Derriford Hospital
Plymouth, PL6 8DH
Austria1 site
Universitätsklinik für Innere Medizin VI Innsbruck, Neurologisches Studienzentrum
Innsbruck, 6020
About this study
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)
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)
- Conditions
- Parkinson Disease
- Being tested
- Placebo oral capsule, PXT002331 - dose 1, PXT002331 - dose 2
- Keywords
- Levodopa-Induced Dyskinesia (LID), Wearing-off, Foliglurax, Parkinson's Disease, mGluR4 PAM
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo oral capsuleDrug
BID
PXT002331 - dose 1Drug
Oral
PXT002331 - dose 2Drug
Oral
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | Not described Receives: Drug: Placebo oral capsule |
| PXT002331 - 10mg | Experimental | Not described Receives: Drug: PXT002331 - dose 1 |
| PXT002331 - 30mg | Experimental | Not described Receives: Drug: PXT002331 - dose 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to end of Treatment Period in the daily awake OFF time based on subject Hauser diary entries
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start4 Jul 2017
- Primary completion19 Feb 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prexton Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162874
- Sponsor's protocol ID
- PXT-CL17-001
- Other IDs
- 18023A
- Acronym
- AMBLED
- Status last verified
- Mar 2020
- First submitted
- 19 May 2017
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03162874
- Acronym / sponsor ID
- AMBLED / PXT-CL17-001
- Conditions
- Parkinson Disease
- Keywords
- Levodopa-Induced Dyskinesia (LID), Wearing-off, Foliglurax, Parkinson's Disease, mGluR4 PAM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Prexton TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PLACEBO | Placebo comparator | Drug: Placebo oral capsule |
| PXT002331 - 10mg | Experimental | Drug: PXT002331 - dose 1 |
| PXT002331 - 30mg | Experimental | Drug: PXT002331 - dose 2 |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo oral capsuleBID | Drug | PLACEBO |
| PXT002331 - dose 1Oral | Drug | PXT002331 - 10mg |
| PXT002331 - dose 2Oral | Drug | PXT002331 - 30mg |
Primary outcome
Change from baseline to end of Treatment Period in the daily awake OFF time based on subject Hauser diary entries
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PXT002331 - dose 1 and PXT002331 - dose 2 in people with Parkinson Disease, run by Prexton Therapeutics at 45 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in France, Italy, Germany, Spain, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to end of Treatment Period in the daily awake OFF time based on subject Hauser diary entries (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.