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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03407378
• Date of registration: 15/01/2018
• Prospective Registration: Yes
• Primary sponsor: Tools4Patient
• Public title: A Study to Investigate a New Treatment in Patients With Parkinson's Disease
• Scientific title: A Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients With Parkinson's Disease
• Date of first enrolment: June 26, 2018
• Target sample size: 110
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03407378
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Single (Participant).
• Phase: Phase 1/Phase 2

Countries of recruitment

Belgium, France, United States

Contacts

• Name: Pereira Alvaro
• Affiliation: Tools4Patient

Key inclusion & exclusion criteria

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.



Age minimum: 35 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Other: Optional Blood-Oxygen-level Dependent functionalMRI

Drug: IPT803

Other: Motor Assessments before taking regular PD treatment

Genetic: Optional pharmacogenetic assessment

Other: Questionnaires

Other: Motor Assessments on regular PD treatment

Primary Outcome(s)

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)]

Secondary Outcome(s)

Cronbach a assessment of MPsQ [Time Frame: at Visit 1 (Day -14 to Day -7), Visit 2 (Day 1) 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 sleep quality as measured by the Epworth Sleep Scale (ESS). [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)]

Investigator change from baseline in disease severity as measured by the Investigator Assessment of Changes (IGAC). [Time Frame: From Visit 2 (Day 1) 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 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 of fatigue as measured by the Fatigue Severity Scale (FSS). [Time Frame: From Visit 1 (Day -14 to Day -7) 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). [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 in disease severity as measured by the Patient Assessment of Changes (PGAC). [Time Frame: From Visit 2 (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). [Time Frame: From Visit 1 (Day -14 to Day -7) up to Visit 4 (Day 85)]

Secondary ID(s)

T1020-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors