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

Parkinson's Disease Clinical Trial

— 03003MAD  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055274
• Other study ID #: LY03003
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2014
• Last updated: October 20, 2015
• Start date: October 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Luye Pharma Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to characterize the pharmacokinetics (PK) of LY03003 following multiple escalating intramuscular injections, as compared to Neupro patch and to evaluate the safety and tolerability and preliminary efficacy of multiple ascending dose (MAD) of LY03003 following intramuscular injections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• LY03003

• Neupro

Locations

Country	Name	City	State
United States	Quest Research Institute	Bingham Farms	Michigan
United States	West Georgia Sleep Disorders Center and Neurology Associates	Douglasville	Georgia
United States	Collaborative Neuroscience Network LLC	Long Beach	California
United States	PRA - CRI Lifetree	Marlton	New Jersey
United States	Compass Research LLC	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Luye Pharma Group Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax for the Pharmacokinetics (PK) of LY03003		5 Weeks	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		5 Weeks	Yes
Secondary	Preliminary efficacy evaluation will be carried out based on Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III)		5 Weeks	Yes