- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03331848
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)
March 20, 2018 updated by: Prexton Therapeutics
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)
This is a Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing Motor Complications of Levodopa Therapy
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
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
Ages Eligible for Study
35 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
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
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: PLACEBO
|
BID
|
EXPERIMENTAL: PXT002331 - 20mg
|
Oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in Unified Dyskinesia Rating Scale (UDysRS) total score in subjects with PD experiencing levodopa-induced dyskinesia.
Time Frame: 26 days
|
26 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ANTICIPATED)
January 15, 2018
Primary Completion (ANTICIPATED)
February 1, 2019
Study Completion (ANTICIPATED)
February 1, 2019
Study Registration Dates
First Submitted
November 1, 2017
First Submitted That Met QC Criteria
November 1, 2017
First Posted (ACTUAL)
November 6, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 22, 2018
Last Update Submitted That Met QC Criteria
March 20, 2018
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PXT-CL17-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
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.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on Placebo oral capsule
-
Sao Thai Duong Joint Stock CompanyBig Leap Clinical Research Joint Stock CompanyCompleted
-
Brigham and Women's HospitalCompleted
-
Georgetown UniversityNational Institutes of Health (NIH)RecruitingDementia With Lewy BodiesUnited States
-
Aelis FarmaNational Institute on Drug Abuse (NIDA)CompletedHealthy VolunteersUnited States
-
Brigham and Women's HospitalEnrolling by invitation
-
EicOsis Human Health Inc.National Institute of Neurological Disorders and Stroke (NINDS)CompletedHealthy AdultsUnited States
-
Brigham and Women's HospitalCompleted
-
Yale UniversityNeurocrine BiosciencesRecruitingTrichotillomania (Hair-Pulling Disorder)United States
-
Alkermes, Inc.Terminated
-
InFlectis BioScienceAssistance Publique Hopitaux De Marseille; Qualissima; Eurofins Optimed; Stragen...Completed