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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.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03589066
Date of registration: 08/06/2018
Prospective Registration: No
Primary sponsor: Luye Pharma Group Ltd.
Public title: Pharmacokinetic Study of LY03003 in Patients With Parkinson's Disease
Scientific title: An Open-label, Randomized, Parallel-group Trial to Evaluate the Pharmacokinetics of Two Formulations of LY03003 After a Single Intramuscular Injection Administered to Patients With Parkinson's Disease
Date of first enrolment: May 15, 2018
Target sample size: 24
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03589066
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Kevin Booth, MD, DVM
Address: 
Telephone:
Email:
Affiliation:  Luye Pharma Group Ltd.
Key inclusion & exclusion criteria

Inclusion Criteria:

- Capable of giving informed consent and complying with trial procedures including the
ability to stay at/return to the CRU for visits at the predetermined times on the
prescribed schedule.

- Has idiopathic Parkinson's Disease (i.e., without any other known or suspected cause
of Parkinsonism) defined by the cardinal signs, bradykinesia, plus the presence of =1
of the following: resting tremor, rigidity, or impairment of postural reflexes.

- Male or female patient =18 years old with BMI of 18.5 to 32 kg/m2, inclusive, and body
weight =50 kg at Screening.

- MMSE score =25 at Screening.

- UPDRS motor (Part III) score = 10 but = 42 at Screening.

- All female patients (childbearing potential and non-childbearing potential) must have
a negative serum pregnancy test result at Screening. In addition, female patients must
meet 1 of the following 3 conditions: (i) postmenopausal for at least 12 months
without an alternative medical cause, (ii) surgically sterile (hysterectomy, bilateral
oophorectomy, bilateral salpingectomy, or bilateral tubal occlusion) based on patient
report, or (iii) if of childbearing potential, practicing or agree to practice a
highly effective method of contraception.

Exclusion Criteria:

- Atypical Parkinson's syndrome(s) due to drugs (e.g., metoclopramide, flunarizine),
metabolic neurogenetic disorders (e.g., Wilson's Disease), encephalitis,
cerebrovascular disease, or degenerative disease (e.g., progressive Supranuclear
Palsy).

- History of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue
transplant.

- Dementia, active psychosis or hallucinations, or clinically significant major
depression requiring psychiatric interventions.

- Lifetime history of suicide attempt (including an active attempt, interrupted attempt,
or aborted attempt) or suicidal ideation in the past 6 months as indicated by a
positive response ("Yes") to either Question 4 or Question 5 of the C-SSRS.

- History of symptomatic orthostatic hypotension with a decrease of =20 mmHg in SBP or
decrease of =10 mmHg in DBP when changing from supine to standing position after
having been in the supine position for at least 5 minutes or SBP less than 105 mmHg in
a supine position at the Screening Visit.

- Therapy with a dopamine (DA) agonist either concurrently or within 21 days prior to
study drug dosing.

- Therapy with 1 or more of the following drugs either concurrently or within 21 days
prior to study drug dosing: monoamine oxidase inhibitors, DA releasing agents, DA
modulating agents, DA antagonists, DA depleting antihypertensives, tricyclic
antidepressants, neuroleptics, or other medications that may interact with DA
function.

- Current diagnosis of epilepsy, history of seizures as an adult, lifetime history of
stroke, or transient ischemic attack (TIA) within 1 year prior to the Screening Visit.

- Female patient who is pregnant or breastfeeding or of childbearing potential without
adequate contraception

- History of prescription drug abuse or illicit drug use, alcohol abuse, or tobacco use
within 6 months prior to the Screening Visit or positive finding in drugs of abuse
test, nicotine test, or alcohol test.

- Any other clinically relevant hepatic, renal, hematologic, and/or cardiac dysfunction,
or other medical condition, or clinically significant laboratory abnormality that
would interfere with the patient's safety or trial outcome in the judgment of the
Investigator.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Parkinson Disease
Intervention(s)
Drug: LY03003
Primary Outcome(s)
AUClast [Time Frame: 22 days]
AUCinf [Time Frame: 22 days]
Cmax [Time Frame: 22 days]
Secondary Outcome(s)
Frequency of serious adverse events [Time Frame: screening, baseline and days 1, 2, 3, 5, 7, 9, 12, 15, 18 and Day 22]
Frequency of adverse events [Time Frame: screening, baseline and days 1, 2, 3, 5, 7, 9, 12, 15, 18 and Day 22]
Secondary ID(s)
LY03003/CT-USA-104
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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