Clinical trial NCT03250117: Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole
Official title: An Open-Label, Relative Bioavailability Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ropinirole Implants in Patients With Parkinson's Disease Switched From Oral Immediate-Release Ropinirole While on L-Dopa
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Dyskinesia
ropinirole
implant
ProNeura
movement disorders
dopamine agonist
extended-release
Parkinsonian disorders
brain diseases
central nervous system diseases
Neurodegenerative Diseases
Antiparkinson agents
Anti-dyskinesia agents
dopamine agents
neurotransmitter agents
REQUIP
subdermal
Lead sponsor: Titan Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-08-15
Enrollment: 6
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Subjects receive oral immediate release (IR) ropinirole for 7-10 days, and then are switched to ropinirole implant(s) for 12 weeks.
Primary purpose: TREATMENT

Brief summary: Subjects stable on L-Dopa and oral ropinirole will have their ropinirole replaced with the Ropinirole Implant(s). The Ropinirole Implant was designed using the ProNeura™ implant technology where the implant is inserted under the skin. This study will measure how much ropinirole is released in the blood during 12 weeks of ropinirole implant treatment, and evaluate the side effects of this new formulation.


Eligibility criteria: Key Inclusion Criteria:

* Voluntarily provided informed consent
* Meet diagnostic criteria for idiopathic Parkinson's Disease
* On L-Dopa and oral ropinirole
* If female of child-bearing potential, willing to practice contraception from time of informed consent to Follow-Up Visit

Key Exclusion Criteria:

* Pregnant, breastfeeding, or planning to become pregnant
* Active epilepsy within the past year
* Severe dementia or cognitive impairment
* Donated or lost \> 400 mL of blood within 1 month prior to Screening
* History of alcohol or substance use disorder within the prior 12 months
* Recent episodes of moderate to severe dizziness or syncope
* Definite or suspected hypersensitivity to ropinirole or ethylene vinyl acetate
* Used any other investigational drug within 60 days or 5 half-lives prior to Screening, or plan to take any such drug any time during the study

Primary outcomes:
measure: AUC0-24 Hours of Ropinirole
timeFrame: 0-24 hours
measure: Total Number of Adverse Events Across Participants
timeFrame: 0-12 weeks
Secondary outcomes:
measure: AUC0-24 Hours of N-despropyl Ropinirole
timeFrame: 0-24 hours
measure: AUC0-24 Hours of 7-hydroxy Ropinirole
timeFrame: 0-24 hours
measure: Mean Change From Baseline in MDS-UPDRS Total Score
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Mean Change From Baseline of Awake Time "On"
timeFrame: Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12
measure: Mean Change From Baseline of Awake Time "Off"
timeFrame: Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando, Florida
state: Florida
city: Farmington Hills
country: United States
facility: Farmington Hills, Michigan
state: Michigan
city: Kirkland
country: United States
facility: Kirkland, Washington
state: Washington
Study officials:
affiliation: Titan Pharmaceuticals
name: Dr. Kate Beebe DeVarney
role: STUDY_DIRECTOR
References: