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

NCT03250117 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: ROP-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (2)

• AUC0-24 Hours of Ropinirole

  Area under the plasma drug concentration-time curve of ropinirole

  0-24 hours

• Total Number of Adverse Events Across Participants

  Safety and tolerability of ropinirole implant(s) presented as the total number of adverse events experienced by the analysis population.

  0-12 weeks

Secondary Outcomes (5)

• AUC0-24 Hours of N-despropyl Ropinirole

  0-24 hours

• AUC0-24 Hours of 7-hydroxy Ropinirole

  0-24 hours

• Mean Change From Baseline in MDS-UPDRS Total Score

  Baseline and Weeks 4, 8 and 12

• Mean Change From Baseline of Awake Time "On"

  Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12

• Mean Change From Baseline of Awake Time "Off"

  Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12

Study Arms (4)

Cohort 1

EXPERIMENTAL

Requip; One Ropinirole Implant

Drug: Ropinirole oral product; Drug: Ropinirole Implant

Cohort 2

EXPERIMENTAL

Requip; Two Ropinirole Implants

Drug: Ropinirole oral product; Drug: Ropinirole Implant

Cohort 3

EXPERIMENTAL

Requip; Three Ropinirole Implants

Drug: Ropinirole oral product; Drug: Ropinirole Implant

Cohort 4

EXPERIMENTAL

Requip; Four Ropinirole Implants

Drug: Ropinirole oral product; Drug: Ropinirole Implant

Interventions

Ropinirole oral product DRUG

oral immediate-release ropinirole

Also known as: Requip

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Ropinirole Implant DRUG

ropinirole hydrochloride/ethylene vinyl acetate

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Titan Pharmaceuticals: lead

Study Sites (3)

Orlando, Florida

Orlando, Florida, 32806, United States

Location

Farmington Hills, Michigan

Farmington Hills, Michigan, 48334, United States

Location

Kirkland, Washington

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias; Movement Disorders; Parkinsonian Disorders; Brain Diseases; Central Nervous System Diseases; Neurodegenerative Diseases

Interventions

ropinirole

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Nervous System Diseases; Synucleinopathies; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a first-in-human study of ropinirole implants. The trial was terminated early at the request of the Sponsor, not for reasons of safety or efficacy.

Results Point of Contact

• Title: Kate Beebe DeVarney, PhD
• Organization: Titan Pharmaceuticals, Inc.

medinfo@titanpharm.com

650-244-4990

Study Officials

• Dr. Kate Beebe DeVarney

  Titan Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects receive oral immediate release (IR) ropinirole for 7-10 days, and then are switched to ropinirole implant(s) for 12 weeks.

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 15, 2017
• Study Start: October 10, 2017
• Primary Completion: May 22, 2018
• Study Completion: May 22, 2018
• Last Updated: May 6, 2023
• Results First Posted: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)