A Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients With Parkinson's Disease
Overview
- Phase
- Phase 1
- Intervention
- Motor Assessments on regular PD treatment
- Conditions
- Parkinson Disease
- Sponsor
- Tools4Patient
- Enrollment
- 110
- Locations
- 10
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Assessments ON regular PD treatment
IPT803 Questionnaires Motor assessments on regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
Intervention: Motor Assessments on regular PD treatment
Assessments ON regular PD treatment
IPT803 Questionnaires Motor assessments on regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
Intervention: IPT803
Assessments ON regular PD treatment
IPT803 Questionnaires Motor assessments on regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
Intervention: Optional pharmacogenetic assessment
Assessments ON regular PD treatment
IPT803 Questionnaires Motor assessments on regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
Intervention: Questionnaires
Assessments ON regular PD treatment
IPT803 Questionnaires Motor assessments on regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
Intervention: Optional Blood-Oxygen-level Dependent functionalMRI
Assessments OFF regular PD treatment
IPT803 Questionnaires Motor assessments before taking regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
Intervention: IPT803
Assessments OFF regular PD treatment
IPT803 Questionnaires Motor assessments before taking regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
Intervention: Optional pharmacogenetic assessment
Assessments OFF regular PD treatment
IPT803 Questionnaires Motor assessments before taking regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
Intervention: Questionnaires
Assessments OFF regular PD treatment
IPT803 Questionnaires Motor assessments before taking regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
Intervention: Optional Blood-Oxygen-level Dependent functionalMRI
Assessments OFF regular PD treatment
IPT803 Questionnaires Motor assessments before taking regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
Intervention: Motor Assessments before taking regular PD treatment
Outcomes
Primary Outcomes
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.
Time Frame: Time zero equals baseline equals (Visit 2 - Day 1 prior to IPT803 first dose) up to Visit 4 (Day 85)
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.
Secondary Outcomes
- 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))
- Investigator change from baseline in disease severity as measured by the Investigator Assessment of Changes (IGAC).(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).(From Visit 2 (Day 1) up to Visit 4 (Day 85))
- Cronbach α assessment of MPsQ(at Visit 1 (Day -14 to Day -7), Visit 2 (Day 1) 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).(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.(Time zero equals baseline (Visit 2 - Day 1 prior to IPT803 first dose) up to Visit 4 (Day 85))