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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

This study is currently recruiting participants.
Verified October 2017 by Titan Pharmaceuticals
Sponsor:
ClinicalTrials.gov Identifier:
NCT03250117
First Posted: August 15, 2017
Last Update Posted: October 19, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Titan Pharmaceuticals
  Purpose
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 Intervention Phase
Parkinson Disease Drug: Ropinirole oral product Drug: Ropinirole Implant Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Titan Pharmaceuticals:

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


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

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


Estimated Enrollment: 20
Actual Study Start Date: October 10, 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Titan Pharmaceuticals 650-244-4990 ROP-001@titanpharm.com

Locations
United States, Florida
Orlando, Florida Recruiting
Orlando, Florida, United States, 32806
Contact    407-210-1157      
United States, Michigan
Farmington Hills, Michigan Recruiting
Farmington Hills, Michigan, United States, 48334
Contact    248-957-8940      
United States, Washington
Kirkland, Washington Not yet recruiting
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Titan Pharmaceuticals
Investigators
Study Director: Rekha Sathyanarayana Titan Pharmaceuticals
  More Information

Responsible Party: Titan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03250117     History of Changes
Other Study ID Numbers: ROP-001
First Submitted: August 11, 2017
First Posted: August 15, 2017
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Ropinirole
Dopamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists