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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 May 2015 |
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Main ID: |
NCT02438215 |
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Date of registration:
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07/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of IRX4204 for Treatment of Early Parkinson's Disease
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Scientific title:
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An Open-Label, Single Site Study Using [123I]ß-CIT Single Photon Emission Tomography (SPECT) to Evaluate Dopamine Transporter Binding Following Treatment With IRX4204 in Early Parkinson's Disease Subjects |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02438215 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Ken Marek, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Molecular NeuroImaging, [MNI] |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: IRX4204
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Primary Outcome(s)
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striatal binding ratio (SBR)
[Time Frame: 30 days]
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Secondary Outcome(s)
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Total Motor and UPDRS scores
[Time Frame: 30 days]
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Safety including hematology and chemistry laboratories, vital signs, and adverse events
[Time Frame: 30 Days]
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Secondary ID(s)
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IRX4204-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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