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Trial record 1 of 1 for:    ropinirole proneura | Parkinson Disease
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Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole

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: NCT03250117
Recruitment Status : Terminated (This study was terminated for reasons not related to efficacy or safety)
First Posted : August 15, 2017
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Titan Pharmaceuticals

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 3 months of treatment, and evaluate the side effects of this new formulation.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Ropinirole oral product Drug: Ropinirole Implant Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 10, 2017
Actual Primary Completion Date : May 22, 2018
Actual Study Completion Date : May 22, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
Requip; One Ropinirole Implant
Drug: Ropinirole oral product
oral immediate-release ropinirole
Other Name: Requip

Drug: Ropinirole Implant
ropinirole hydrochloride/ethylene vinyl acetate

Experimental: Cohort 2
Requip; Two Ropinirole Implants
Drug: Ropinirole oral product
oral immediate-release ropinirole
Other Name: Requip

Drug: Ropinirole Implant
ropinirole hydrochloride/ethylene vinyl acetate

Experimental: Cohort 3
Requip; Three Ropinirole Implants
Drug: Ropinirole oral product
oral immediate-release ropinirole
Other Name: Requip

Drug: Ropinirole Implant
ropinirole hydrochloride/ethylene vinyl acetate

Experimental: Cohort 4
Requip; Four Ropinirole Implants
Drug: Ropinirole oral product
oral immediate-release ropinirole
Other Name: Requip

Drug: Ropinirole Implant
ropinirole hydrochloride/ethylene vinyl acetate




Primary Outcome Measures :
  1. AUC of ropinirole [ Time Frame: 0-24 hours ]
    Area under the plasma drug concentration-time curve of ropinirole


Secondary Outcome Measures :
  1. AUC of N-despropyl ropinirole [ Time Frame: 0-24 hours ]
    Area under the plasma drug concentration-time curve of N-despropyl ropinirole

  2. AUC of 7-hydroxy ropinirole [ Time Frame: 0-24 hours ]
    Area under the plasma drug concentration-time curve of 7-hydroxy ropinirole



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03250117


Locations
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United States, Florida
Orlando, Florida
Orlando, Florida, United States, 32806
United States, Michigan
Farmington Hills, Michigan
Farmington Hills, Michigan, United States, 48334
United States, Washington
Kirkland, Washington
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Titan Pharmaceuticals
Investigators
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Study Director: Dr. Kate Beebe DeVarney Titan Pharmaceuticals
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Responsible Party: Titan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03250117    
Other Study ID Numbers: ROP-001
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Titan Pharmaceuticals:
Parkinson Disease
ropinirole
ProNeura
movement disorders
Parkinsonian disorders
brain diseases
central nervous system diseases
Neurodegenerative Diseases
REQUIP
Dyskinesia
implant
dopamine agonist
extended-release
Antiparkinson agents
Anti-dyskinesia agents
dopamine agents
neurotransmitter agents
subdermal
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
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs