Study to Evaluate the Efficacy, Safety, and Tolerability of PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03331848
• Date of registration: 01/11/2017
• Prospective Registration: Yes
• Primary sponsor: Prexton Therapeutics
• Public title: Study to Evaluate the Efficacy, Safety, and Tolerability of PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED) ATTUNED
• Scientific title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety, and Tolerability of 8-week Oral Treatment With PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED)
• Date of first enrolment: January 15, 2018
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03331848
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Key inclusion & exclusion criteria

Inclusion Criteria:

- Between 35 and 85 years of age, inclusive, at the time of signing informed consent

- Diagnosed after the age of 30 years with idiopathic PD

- A documented medical history of 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 must be receiving at least 3 doses per day of levodopa-containing therapy,
and must be on a stable dose for at least 2 weeks for immediate-release levodopa or at
least 6 weeks for prolonged-release levodopa preparations prior to the first screening
visit

- Experienced LID over a period of at least 3 months prior to randomization

- If needed, in the opinion of the investigator, subjects must have a caregiver

- Female subjects will be women of non-childbearing potential

Exclusion Criteria:

- Patient is currently participating in or has participated in another study in the last
3 months

- Subjects with atypical, secondary, or drug-induced Parkinsonism

- Subjects with a history of dyskinesia that was exclusively diphasic, OFF state,
myoclonic, dystonic, or akathetic without peak-dose dyskinesia

- Subjects with a MoCA score of <25

- Subjects who have, or who had a history of, any clinically significant hepatic or
gallbladder disorder, as determined by the investigator

- Subjects who have dementia, currently active psychosis, or hallucinations.

- Suicide attempt within 1 year prior to the first screening visit, or severe suicidal
ideation within 6 months prior to the first screening visit

- Subject has a current diagnosis of epilepsy,

- Any known contraindication to the use of levodopa, including a history of malignant
melanoma or a history of narrow-angle glaucoma

- Carcinoma or successfully treated squamous cell carcinoma of the skin and no sing of
disease recurrence for at least 5 years

- Subjects who have had a clinically significant illness within 4 weeks before the first
dose, as determined by the investigator

- Subjects with scheduled surgeries/hospitalizations during the study period

- 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,

- Subjects currently taking (or expected to be administered during the course of the
study) any of the prohibited medications (amantadine, safinamide,
dopamine-antagonists).



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

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: PXT002331 - 20mg

Drug: Placebo oral capsule

Primary Outcome(s)

Change from baseline in Unified Dyskinesia Rating Scale (UDysRS) total score in subjects with PD experiencing levodopa-induced dyskinesia. [Time Frame: 26 days]

Secondary ID(s)

PXT-CL17-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors