Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients (AMBLED)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03162874 |
Recruitment Status :
Completed
First Posted : May 22, 2017
Last Update Posted : March 17, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease | Drug: Placebo oral capsule Drug: PXT002331 - dose 1 Drug: PXT002331 - dose 2 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 157 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 |
Actual Primary Completion Date : | February 19, 2020 |
Actual Study Completion Date : | March 2, 2020 |

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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 35 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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

Responsible Party: | Prexton Therapeutics |
ClinicalTrials.gov Identifier: | NCT03162874 |
Other Study ID Numbers: |
PXT-CL17-001 18023A ( Other Identifier: Lundbeck ) |
First Posted: | May 22, 2017 Key Record Dates |
Last Update Posted: | March 17, 2020 |
Last Verified: | March 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Levodopa-Induced Dyskinesia (LID) Wearing-off Foliglurax Parkinson's Disease mGluR4 PAM |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |