Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03162874
• Date of registration: 19/05/2017
• Prospective Registration: Yes
• Primary sponsor: Prexton Therapeutics
• Public title: Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients AMBLED
• Scientific 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)
• Date of first enrolment: July 4, 2017
• Target sample size: 157
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03162874
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Austria, France, Germany, Italy, Spain, United Kingdom

Key inclusion & exclusion 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.



Age minimum: 35 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: PXT002331 - dose 2

Drug: PXT002331 - dose 1

Drug: Placebo oral capsule

Primary Outcome(s)

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

Secondary ID(s)

18023A

PXT-CL17-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors