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Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole

NCT03250117 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-05-06

Study results available
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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.

Conditions

  • Parkinson Disease

Interventions

DRUG

Ropinirole oral product

oral immediate-release ropinirole

DRUG

Ropinirole Implant

ropinirole hydrochloride/ethylene vinyl acetate

Sponsors & Collaborators

  • Titan Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Dr. Kate Beebe DeVarney · Titan Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-10
Primary Completion
2018-05-22
Completion
2018-05-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03250117 on ClinicalTrials.gov