Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

A Single Group and Open-label Study to Evaluate Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728947
• Other study ID #: LY03003-CT-USA-103
• Status: Completed
• Phase: Phase 1
• First received: March 31, 2016
• Last updated: December 2, 2016
• Start date: May 2016
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• 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

To study the profile of Neupro patch administrated at 2 mg, 4 mg, 6 mg and 8 mg/day weekly in patients with early-stage Parkinson's disease

Description:

A single group and open-label study to evaluate pharmacokinetic profile of Neupro patch administrated at 2 mg, 4 mg, 6 mg and 8 mg/day weekly in patients with early-stage Parkinson's disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Patient who is capable of giving informed consent and complying with study procedures

2. Patient who 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

3. Patient who is Hoehn & Yahr stage less than or equal to 3

4. Patient who is male or female aged greater than or equal to 18 years at Screening

5. Patient who has a Mini Mental State Examination (MMSE) score of greater than or equal to 25

6. Patient who has a Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) of greater than or equal to 10 but less then or equal to 30 at Screening

Exclusion Criteria:

1. Patient who 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. Patient who has a history of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue transplant

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

4. Patient who 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 (C-SSRS) at Screening

5. Patient who has a history of symptomatic orthostatic hypotension with a decrease of less than or equal to 20 mmHg in systolic blood pressure (SBP) or great than or equal to 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. Patient who is receiving therapy with a dopamine agonist either concurrently or has done so within 28 days prior to the Screening

7. Patient who 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. Patient who 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. Patient who 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. Patient who has a history of known intolerance/hypersensitivity to non-dopaminegic antiemetics, such as domperidone, ondansetron, tropisetron, and glycopyrrolate

11. Patient who 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 patient's ability to participate in the study

12. Patient who has a history of significant skin hypersensitivity to adhesive or other transdermal preparations or recent unresolved contact Dermatitis

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

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

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• ROTIGOTINE
1 week at each dose

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	MD Clinical	Hallandale Beach	Florida
United States	CNS Network	Long Beach	California

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 of ROTIGOTINE	PK parameters Cmax-ss	38 Days	Yes