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Study of IRX4204 for Treatment of Early Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02438215
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Io Therapeutics

Brief Summary:
This is a single site, open-label study designed to examine dopamine transporter density using [123I]β-CIT SPECT imaging before and following treatment with IRX4204 for a 30-day period in early Parkinson's disease patients. In addition, clinical evaluations will be performed to evaluate the effect of IRX4204 treatment on the motor and cognitive symptoms of PD.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: IRX4204 Phase 1

Detailed Description:
Fifteen patients with early PD were enrolled in this open label study, in 3 cohorts of 5 patients each, treated with IRX4204 at 5 mg/day, 10mg/day, or 20 mg/day. Patients were administered IRX4204 orally once daily. Baseline assessments were performed for total motor score, and Unified Parkinson's Disease Rating Scale (UPDRS). Follow-up assessments of these clinical outcome measures were performed at 14 and 29 days of treatment. [123]β-CIT SPECT imaging for assessment of dopamine active transporter (DAT) expression was performed at baseline, and on day 30 of IRX4204 treatment. Patients had clinical hematology and chemistry laboratory tests, and recording of adverse events, performed at baseline and at follow up visits.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single Site Study Using [123I]β-CIT Single Photon Emission Tomography (SPECT) to Evaluate Dopamine Transporter Binding Following Treatment With IRX4204 in Early Parkinson's Disease Subjects
Study Start Date : August 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IRX4204
IRX4204 20 mg QD for Days 1-30
Drug: IRX4204
IRX4204 is a potent and highly selective orally available and brain penetrant RXR nuclear receptor agonist small compound administered as gel capsules.
Other Name: NRX194204




Primary Outcome Measures :
  1. striatal binding ratio (SBR) [ Time Frame: 30 days ]
    The percent change from baseline to end of dosing period (Day 30) of the striatal binding ratio (SBR)


Secondary Outcome Measures :
  1. Total Motor and UPDRS scores [ Time Frame: 30 days ]
    The change in motor and UPDRS scores to end of dosing period (Day 30)

  2. Safety including hematology and chemistry laboratories, vital signs, and adverse events [ Time Frame: 30 Days ]
    Clinically significant changes in hematology and chemistry laboratories, vital signs, and frequency of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant is 40-80 years of age, inclusive.
  2. Participant has a clinical diagnosis of PD based on the UK Brain Bank Criteria.
  3. Participant has Hoehn and Yahr stage < 3.
  4. Participant may be treated with PD symptomatic therapy on a stable dose for at least 30 days prior to the Screening Visit. Dose levels of PD symptomatic therapies will remain stable through the patient's participation in the study, unless a change of dose level is indicated because of adverse events.
  5. Participant must be willing and able to provide informed consent.
  6. Females must be of either non-child bearing potential based on:

    • post-menopausal for at least 2 years, or
    • surgically sterilized If of child bearing potential, must be neither pregnant or breastfeeding at Screening, and must be willing to avoid pregnancy by using medically accepted contraception (use of an intrauterine device or use of a double barrier method when engaging in sexual intercourse with a male partner) for 4 weeks prior to and 4 weeks following the last dose of study medication.

Exclusion Criteria:

  1. Has any form of parkinsonism other than idiopathic PD
  2. Are currently experiencing motor fluctuations (end of dose wearing off or dyskinesias) reflective of later stage PD
  3. Has evidence of dementia or significant cognitive dysfunction
  4. Has clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
  5. The subject has any disorder that may interfere with drug absorption, distribution, metabolism or excretion.
  6. The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
  7. Pregnancy or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438215


Locations
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United States, Connecticut
Molecular NeuroImaging, [MNI]
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Io Therapeutics
Investigators
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Principal Investigator: Ken Marek, MD Molecular NeuroImaging, [MNI]

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Responsible Party: Io Therapeutics
ClinicalTrials.gov Identifier: NCT02438215    
Other Study ID Numbers: IRX4204-001
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Keywords provided by Io Therapeutics:
PD
Parkinson's Disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases