A Study to Investigate a New Treatment in Patients With Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-26

Study Completion Date

2020-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Assessments ON regular PD treatment

IPT803 Questionnaires Motor assessments on regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI

Group Type EXPERIMENTAL

IPT803

Intervention Type DRUG

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.

Optional pharmacogenetic assessment

Intervention Type GENETIC

Blood sample of 3 milliliters for genotyping assessment (according to patient consent).

Questionnaires

Intervention Type OTHER

Personality, Health and Disease questionnaires completion during the study (Visits 1, 2, 3 and 4)

Optional Blood-Oxygen-level Dependent functionalMRI

Intervention Type OTHER

BOLD fMRI performed in a sub-group of patients, depending of randomization (exploratory)

Motor Assessments on regular PD treatment

Intervention Type OTHER

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.

Assessments OFF regular PD treatment

IPT803 Questionnaires Motor assessments before taking regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI

Group Type EXPERIMENTAL

IPT803

Intervention Type DRUG

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.

Optional pharmacogenetic assessment

Intervention Type GENETIC

Blood sample of 3 milliliters for genotyping assessment (according to patient consent).

Questionnaires

Intervention Type OTHER

Personality, Health and Disease questionnaires completion during the study (Visits 1, 2, 3 and 4)

Optional Blood-Oxygen-level Dependent functionalMRI

Intervention Type OTHER

BOLD fMRI performed in a sub-group of patients, depending of randomization (exploratory)

Motor Assessments before taking regular PD treatment

Intervention Type OTHER

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.

Interventions

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IPT803

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.

Intervention Type DRUG

Optional pharmacogenetic assessment

Blood sample of 3 milliliters for genotyping assessment (according to patient consent).

Intervention Type GENETIC

Questionnaires

Personality, Health and Disease questionnaires completion during the study (Visits 1, 2, 3 and 4)

Intervention Type OTHER

Optional Blood-Oxygen-level Dependent functionalMRI

BOLD fMRI performed in a sub-group of patients, depending of randomization (exploratory)

Intervention Type OTHER

Motor Assessments before taking regular PD treatment

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.

Intervention Type OTHER

Motor Assessments on regular PD treatment

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Men or women of at least 35 years of age;
2. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures;
3. Have given written informed consent approved by the relevant Ethics Committee (EC)/Institutional Review Board (IRB) governing the study site(s);
4. 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;
5. Patients with a Hoehn and Yahr Stage \< 3;
6. Patients with a MMSE ≥ 26;
7. 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;

Exclusion Criteria

8. Pregnant (urine pregnancy test), breastfeeding, or willing to be pregnant during the study;
9. Presence of clinically significant medical or psychiatric condition that may increase the risk associated with study participation or investigational product/device administration or participation in any other type of medical research that may interfere with the interpretation of study results in the judgment of the sponsor/investigator or in an exclusion period according to national law, would make the subject inappropriate for entry into this study;
10. Has a history of psychotic symptoms requiring treatment with a neuroleptic medication within the past 12 months;
11. Any current primary psychiatric condition, including not stabilized mood disorders, personality disorders or mental retardation based on diagnostic following DSM-V;
12. Any known hypersensitivity to corn and/or corn-derived products;
13. Alcohol dependence or regular use of known drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine);
14. 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;
15. Any close relationship with the investigators or employees or consultants of the sponsor (i.e. belonging to immediate family or subordination relationship);
16. Under legal protection, according to the national law (for French sites only);
17. Are persons who have previously received IPT803, have completed or withdrawn from this study or any other study investigating IPT803.
18. 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;
19. Patients with motor complications (wearing off; dyskinesia) that would interfere with study procedures;
20. Patients with history or clinical features consistent with an atypical Parkinsonian syndrome (for example: supranuclear gaze palsy, clinically significant orthostatic hypotension);
21. History of surgical or invasive intervention for PD (pallidotomy, thalamotomy, deep brain stimulation, etc.);
22. Any Parkinson's disease-related feature or symptom that could interfere with the study conduct and results as assessed by the investigator.

Exclusion Imaging (BOLD fMRI) criteria for patients following Imaging Procedure:
23. Patients unable to undergo MRI scans, including suffering from claustrophobia;
24. Have implanted or embedded metal objects or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field according to investigator site judgment.

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No