Pharmacokinetics and Safety Study of LY03003 in Patients With Early-stage Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 2 November 2015
• Main ID: NCT02055274
• Date of registration: 31/01/2014
• Prospective Registration: No
• Primary sponsor: Luye Pharma Group Ltd.
• Public title: Pharmacokinetics and Safety Study of LY03003 in Patients With Early-stage Parkinson's Disease 03003MAD
• Scientific title: A Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections
• Date of first enrolment: October 2013
• Target sample size: 39
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02055274
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Simon Li
• Affiliation: Luye Pharma Group Ltd.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subject has Idiopathic Parkinson's Disease defined by the cardinal sign,
Bradykinesia, plus the presence of at least 1 of the following: resting tremor,
rigidity, or impairment of postural reflexes, and without any other known or
suspected cause of Parkinsonism

2. Subject is Hoehn & Yahr stage =3

3. Subject is male or female aged =18 years at Screening

4. Subject has a Mini Mental State Examination (MMSE) score of =25

5. Subject has a Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III)
of =10 but =30 at Screening

Exclusion Criteria:

1. Subject has 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)

2. Subject has a history of Pallidotomy, Thalamotomy, deep brain stimulation, or fetal
tissue transplant

3. Subject has dementia, active psychosis or hallucinations, or clinically significant
depression

4. Subject has a lifetime history of suicide attempt (including an active attempt,
interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6
months as indicated by a positive response ("Yes") to either Question 4 or Question 5
of the Columbia-Suicide Severity Rating Scale (CSSRS) at Screening

5. Subject has a history of symptomatic orthostatic hypotension with a decrease of =20
mmHg in systolic blood pressure (SBP) or =10 mmHg in diastolic blood pressure when
changing from supine to standing position after having been at supine position for at
least 5 minutes within 28 days prior to the Screening Visit, or SBP less than 105
mmHg at study entry, or reports clinical signs of clinically significant orthostatic
hypotension within 28 days prior to the Screening Visit.

6. Subject is receiving therapy with a dopamine agonist (DA) either concurrently or has
done so within 28 days prior to the Screening

7. Subject is receiving therapy with 1 of the following drugs either concurrently or
within 28 days prior to screening: MAO-B inhibitors, DA releasing agents, DA
modulating agent, DA antagonists, neuroleptics, or other medications that may
interact with DA function.

8. Subject is currently receiving central nervous system active therapy (e.g.,
sedatives, hypnotics, antidepressants, anxiolytics), unless the dose has been stable
for at least 28 days prior to Screening Visit and is likely to remain stable for the
duration of the study. Patients should not take those medications within 8 hours
prior to clinical visits

9. Subject has a current diagnosis of epilepsy, has a history of seizures as an adult,
has a history of stroke, or has had a transient ischemic attack within 1 year prior
to Screening

10. Subject has a history of known intolerance/hypersensitivity to non-dopaminergic
antiemetics, such as domperidone, ondansetron, tropisetron, and glycopyrrolate

11. Subject has any other clinically relevant hepatic, renal and cardiac dysfunction, or
other medical condition or laboratory abnormality including abnormal plasma magnesium
level, which would in the judgment of the investigator, interfere with the subject's
ability to participate in the study

12. Subject has a history of significant skin hypersensitivity to adhesive or other
transdermal preparations or recent unresolved contact Dermatitis (this item is
specific for patients to be enrolled to part 2 of this study)

13. Subjects with C-reactive protein levels of 2x of upper limit of normal range

14. Female subjects who are pregnant or are breastfeeding or are of childbearing
potential without adequate contraception.

15. Patients with a positive finding in drug screening test or alcohol test



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: LY03003

Drug: Neupro

Primary Outcome(s)

Cmax for the Pharmacokinetics (PK) of LY03003 [Time Frame: 5 Weeks]

Secondary Outcome(s)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Time Frame: 5 Weeks]

Preliminary efficacy evaluation will be carried out based on Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) [Time Frame: 5 Weeks]

Secondary ID(s)

LY03003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors