Study of IRX4204 for Treatment of Early Parkinson's Disease

NCT02438215 | Completed Phase 1 DMC

• 1 other identifier: IRX4204-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

PD; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• striatal binding ratio (SBR)

  The percent change from baseline to end of dosing period (Day 30) of the striatal binding ratio (SBR)

  30 days

Secondary Outcomes (2)

• Total Motor and UPDRS scores

  30 days

• Safety including hematology and chemistry laboratories, vital signs, and adverse events

  30 Days

Study Arms (1)

IRX4204

EXPERIMENTAL

IRX4204 20 mg QD for Days 1-30

Drug: IRX4204

Interventions

IRX4204 DRUG

IRX4204 is a potent and highly selective orally available and brain penetrant RXR nuclear receptor agonist small compound administered as gel capsules.

Also known as: NRX194204

IRX4204

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is 40-80 years of age, inclusive.
• Participant has a clinical diagnosis of PD based on the UK Brain Bank Criteria.
• Participant has Hoehn and Yahr stage \< 3.
• 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.
• Participant must be willing and able to provide informed consent.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Io Therapeutics: lead

Study Sites (1)

Molecular NeuroImaging, [MNI]

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

IRX4204; AGN 194204

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ken Marek, MD

  Molecular NeuroImaging, [MNI]

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: May 8, 2015
• Study Start: August 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

US (1)