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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
110
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)
University of Colorado School of Medicine
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
Northwestern
Chicago, Illinois, United States
Henry Ford
West Bloomfield, Michigan, United States
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 frame: 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 safety incidence as measured by the rate and severity of Treatment emergent adverse event (TEAEs).
Time frame: 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).
The MDS-UPDRS is divided into 4 parts. In each part, all items are rated on a scale from 0 (normal) to 4 (severe impairment). Part I assesses 15 items of non-motor aspects of experiences of daily living. Part IA is assessed by a qualified rater, Part IB is completed by the patient. The total score, being the sum of all these items, can be between 0 to 60. Part II comprises 13 items evaluating the impact of PD on patients' activities of daily living (ADL) over the week prior to the visit such as speech, salivation, swallowing, eating, handwriting, dressing, turning in bed, walking. It will be completed by the patient. The total score, being the sum of all these items, can be between 0 to 52. Part IV assesses motor complications of therapy, such as dyskinesias, motor fluctuations. This part (6 items) is completed by a qualified rater. The total score, being the sum of all these items, can be between 0 to 24.
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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.
Columbia
New York, New York, United States
CHU Liege - Liège University
Liège, Belgium
CHU Grenoble
Grenoble, France
CHU Poitiers
Poitiers, France
CHU Rennes - Hopital Pontchaillou
Rennes, France
CHU Purpan - Hopital Pierre Paul Riquet
Toulouse, France
Time frame: 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).
Time frame: 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).
The FSS is a self-administered questionnaire with 9 items assessing the severity of fatigue during the past 2 weeks. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement, where the addition of all numbers circled by patient get the final score.
Time frame: 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).
The ESS assesses the overall level of daytime sleepiness. Eight items describe normative daily situations known to vary in their soporific qualities. Patients rate the likelihood of dozing off or falling asleep. The test is rated on a 4-point scale (0=would never doze off to 3=high chance of dozing off).
Time frame: From Visit 1 (Day -14 to Day -7) up to Visit 4 (Day 85)
Investigator change from baseline in disease severity as measured by the Investigator Assessment of Changes (IGAC).
IGAC is a subjective evaluation by the Investigator using a 0 to 10 Numeric Rating Scale (NRS) to answer the following question: "If you take into consideration all the various ways that motor control influences the patient and his/her life, how do you then evaluate the patient's motor condition today?", with 0 meaning "very bad" and 10 "very good".
Time frame: From Visit 2 (Day 1) up to Visit 4 (Day 85)
Patient's change from baseline in disease severity as measured by the Patient Assessment of Changes (PGAC).
PGAC is a subjective evaluation by the patient using a 0 to 10 Numeric Rating Scale (NRS) to answer the following question: "If you take into consideration all the various ways that motor control influences you and your life, how do you then evaluate your motor condition over the last week?", with 0 meaning "very bad" and 10 meaning "very good".
Time frame: From Visit 2 (Day 1) up to Visit 4 (Day 85)
Patient's change from baseline above or equal to the minimal clinically important difference (MCID) of the motor score as measured by Part II and III subscales of Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
The Minimal Clinically Important Difference (MCID) is the smallest change in an outcome measure that is meaningful for patients. In the literature, the MCIDs of MDS-UPDRS Part II and Part III are respectively defined as a motor score reduction of 2 and 6 points. The motor scores are the sum of all items (ranging from 0-4) of each MDS-UPDRS subscale. Following endpoints will be measured: * A reduction above or equal to 2 points of MDS-UPDRS Part II motor score (minimum score= 0, maximal score= 52) * A reduction above or equal to 6 points of MDS-UPDRS Part III motor score (minimum score= 0, maximal score= 136) These endpoints will be interpreted as binary values: 0 (below) and 1 (above or equal).
Time frame: Time zero equals baseline (Visit 2 - Day 1 prior to IPT803 first dose) up to Visit 4 (Day 85)
Patient's change from baseline above or equal to 30 % or above or equal to 50 % of the motor score as measured by Part II and III subscales of MDS-UPDRS.
The motor scores are the sum of all items (ranging from 0-4) of each MDS-UPDRS subscale. Following endpoints will be measured: * A reduction above or equal to 30% of MDS-UPDRS Part II motor score * A reduction above or equal to 30% of MDS-UPDRS Part III motor score * A reduction above or equal to 50% of MDS-UPDRS Part II motor score * A reduction above or equal to 50% of MDS-UPDRS Part III motor score These endpoints will be interpreted as binary values: 0 (below) and 1 (above or equal).
Time frame: Time zero equals baseline (Visit 2 - Day 1 prior to IPT803 first dose) up to Visit 4 (Day 85)
Cronbach α assessment of MPsQ
Time frame: at Visit 1 (Day -14 to Day -7), Visit 2 (Day 1) Visit 4 (Day 85)