A Study to Investigate a New Treatment in Patients With Parkinson's Disease
A Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients With Parkinson's Disease
1 other identifier
interventional
110
3 countries
10
Brief Summary
The purpose of this clinical trial conducted in patients with Parkinson's Disease is to study the relationship between patient individual profile and their response to IPT803 Adjunct Treatment (treatment response being characterized by movements improvement).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 parkinson-disease
Started Jun 2018
Typical duration for phase_1 parkinson-disease
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2018
CompletedFirst Posted
Study publicly available on registry
January 23, 2018
CompletedStudy Start
First participant enrolled
June 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedJune 16, 2020
June 1, 2020
1.6 years
January 15, 2018
June 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Patient's change from baseline of score as measured by Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS; Part III), after 12 weeks of IPT803 administration.
Part III of the MDS-UPDRS (or motor examination) assesses the motor abilities in PD patients at the time of the visit. This part measures 18 motor examinations such as speech, facial expression, tremor, rigidity, finger tapping, pronation-supination movements of hands, leg agility, arising from chair, gait. The qualified rater must score 34 items from 0 to 4, where 0 indicates a normal situation and 4 indicates that PD interferes severely in carrying out the task. The total score, being the sum of all these items, can be between 0 to 136.
Time zero equals baseline equals (Visit 2 - Day 1 prior to IPT803 first dose) up to Visit 4 (Day 85)
Secondary Outcomes (10)
Patient's change from baseline of safety incidence as measured by the rate and severity of Treatment emergent adverse event (TEAEs).
Time zero equals baseline Visit 2 IPT803 first dose (Day 1) up to Visit 4 (Day 85)
Patient's change from baseline of motor and non-motor outcomes as measured by Part I, Part II and IV subscales of Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
From Visit 1 (Day -14 to Day -7) up to Visit 4 (Day 85)
The patient's change from baseline in disease severity as measured by the Parkinson's Disease Questionnaire (PDQ-39).
From Visit 2 (Day 1) up to Visit 4 (Day 85)
Patient's change from baseline of fatigue as measured by the Fatigue Severity Scale (FSS).
From Visit 1 (Day -14 to Day -7) up to Visit 4 (Day 85)
Patient's change from baseline of sleep quality as measured by the Epworth Sleep Scale (ESS).
From Visit 1 (Day -14 to Day -7) up to Visit 4 (Day 85)
- +5 more secondary outcomes
Other Outcomes (3)
Patient's change from baseline of motor score, as measured by Inertial Measurement Unit (IMU) on Finger taping (FT) and Pronation-supination movement of the hands (PSH) during the 12-week treatment.
Time zero equals baseline equals (Visit 2 - Day 1 prior to IPT803 first dose) up to Visit 4 (Day 85)
Patient's change from baseline of the regional brain activity as measured by BOLD fMRI measured by motor tasks performed during fMRI before and after single dose of IPT803.
On Day 1: prior to IPT 803 first dose and 60 minutes after IPT803 first dose
Patient's change of motor score, as measured by Part III subscale of MDS-UPDRS directly after IPT803 single dose.
On Day 1: prior to IPT 803 first dose and 30 minutes after IPT803 first dose
Study Arms (2)
Assessments ON regular PD treatment
EXPERIMENTALIPT803 Questionnaires Motor assessments on regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
Assessments OFF regular PD treatment
EXPERIMENTALIPT803 Questionnaires Motor assessments before taking regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
Interventions
Administration of IPT803 three times a day for 12 weeks as add-on therapy to patient regular PD medication(s) or as a new therapy for drug naïve patients.
Blood sample of 3 milliliters for genotyping assessment (according to patient consent).
Personality, Health and Disease questionnaires completion during the study (Visits 1, 2, 3 and 4)
BOLD fMRI performed in a sub-group of patients, depending of randomization (exploratory)
Regular PD treatment stopped 12 or 24 hours prior to Visits 2, 3 and 4 depending on the drug form (extended vs standard release). Motor assessments using UPDRS Part III are performed when patients are OFF regular PD treatment. Regular PD treatment is taken on site during the visit after the motor assessments are performed.
Regular PD treatment is not modified before the visits. The motor assessments using UPDRS Part III are performed while the patient is on regular PD treatment.
Eligibility Criteria
You may qualify if:
- Men or women of at least 35 years of age;
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures;
- Have given written informed consent approved by the relevant Ethics Committee (EC)/Institutional Review Board (IRB) governing the study site(s);
- Medically stable outpatients with idiopathic PD based on the MDS-PD criteria (Postuma et al 2015). The diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity or postural instability not caused by primary visual, vestibular, cerebellar, or proprioceptive dysfunction) being present, without any other known or suspected cause of Parkinson;
- Patients with a Hoehn and Yahr Stage \< 3;
- Patients with a MMSE ≥ 26;
- Patient stabilized with PD medication(s) e.g. levodopa, dopamine agonists, amantadine and/or Monoamine oxidase (MAO)-B inhibitors for at least 4 weeks prior to Visit 1 and and up to Visit 4 included or Drug naïve patients recently diagnosed with PD according to the criteria above and for whom PD medication(s) may be initiated after Visit 4;
You may not qualify if:
- Pregnant (urine pregnancy test), breastfeeding, or willing to be pregnant during the study;
- Has a history of psychotic symptoms requiring treatment with a neuroleptic medication within the past 12 months;
- Any current primary psychiatric condition, including not stabilized mood disorders, personality disorders or mental retardation based on diagnostic following DSM-V;
- Any known hypersensitivity to corn and/or corn-derived products;
- Alcohol dependence or regular use of known drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine);
- Any other relevant medical disorder/acute disease state judged by the Investigator as likely to interfere with study procedures or represent a risk for the patient;
- Any close relationship with the investigators or employees or consultants of the sponsor (i.e. belonging to immediate family or subordination relationship);
- Under legal protection, according to the national law (for French sites only);
- Are persons who have previously received IPT803, have completed or withdrawn from this study or any other study investigating IPT803.
- Change in the patient's regular PD medication(s) (dosage or dosing interval) or introduction of a new regular PD medication(s) within 4 weeks prior to Visit 1 and up to Visit 4 included;
- Patients with motor complications (wearing off; dyskinesia) that would interfere with study procedures;
- Patients with history or clinical features consistent with an atypical Parkinsonian syndrome (for example: supranuclear gaze palsy, clinically significant orthostatic hypotension);
- History of surgical or invasive intervention for PD (pallidotomy, thalamotomy, deep brain stimulation, etc.);
- Any Parkinson's disease-related feature or symptom that could interfere with the study conduct and results as assessed by the investigator.
- Patients unable to undergo MRI scans, including suffering from claustrophobia;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tools4Patientlead
Study Sites (10)
University of Colorado School of Medicine
Aurora, Colorado, 80045, United States
University of Florida
Gainesville, Florida, 32607, United States
Northwestern
Chicago, Illinois, 60611, United States
Henry Ford
West Bloomfield, Michigan, 48322, United States
Columbia
New York, New York, 10032, United States
CHU Liege - Liège University
Liège, 4000, Belgium
CHU Grenoble
Grenoble, 38043, France
CHU Poitiers
Poitiers, 86021, France
CHU Rennes - Hopital Pontchaillou
Rennes, 35033, France
CHU Purpan - Hopital Pierre Paul Riquet
Toulouse, 31059, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pereira Alvaro
Tools4Patient
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2018
First Posted
January 23, 2018
Study Start
June 26, 2018
Primary Completion
February 7, 2020
Study Completion
March 31, 2020
Last Updated
June 16, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share