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Pharmacokinetics and Safety Study of LY03003 in Patients With Early-stage Parkinson's Disease (03003MAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02055274
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
Luye Pharma Group Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: LY03003 Drug: Neupro Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Rotigotine

Arm Intervention/treatment
Experimental: LY03003
4 Stable doses of LY03003 14, 28, 42 and 56 mg
Drug: LY03003
Active Comparator: Neupro
Neupro patch 2 mg/24 hours in the first week, and then be titrated to 4, 6 and 8 mg/24 hours at weekly intervals
Drug: Neupro
Active Comparator: Neupro PK
Neupro patch 2 mg/24hr in the first week then titrated to 4 and 6mg/24hr
Drug: Neupro



Primary Outcome Measures :
  1. Cmax for the Pharmacokinetics (PK) of LY03003 [ Time Frame: 5 Weeks ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 5 Weeks ]
  2. Preliminary efficacy evaluation will be carried out based on Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) [ Time Frame: 5 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055274


Locations
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United States, California
Collaborative Neuroscience Network LLC
Long Beach, California, United States, 90806
United States, Florida
Compass Research LLC
Orlando, Florida, United States, 32806
United States, Georgia
West Georgia Sleep Disorders Center and Neurology Associates
Douglasville, Georgia, United States, 30134
United States, Michigan
Quest Research Institute
Bingham Farms, Michigan, United States, 48025
United States, New Jersey
PRA - CRI Lifetree
Marlton, New Jersey, United States, 08053
Sponsors and Collaborators
Luye Pharma Group Ltd.
Investigators
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Study Director: Simon Li Luye Pharma Group Ltd.

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Responsible Party: Luye Pharma Group Ltd.
ClinicalTrials.gov Identifier: NCT02055274    
Other Study ID Numbers: LY03003
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015
Keywords provided by Luye Pharma Group Ltd.:
Parkinsons
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs