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2 Year Study to Evaluate the Effects of GPI 1485 on [123I]b-CIT/SPECTScanning and Clinical Efficacy in Patients With PD

NCT00209508 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2008-11-07

No results posted yet for this study

Summary

This study was designed to assess whether GPI 1485 has the ability to delay or stop disease progression and improve symptoms in patients with Parkinson's disease (PD) that is already being treated with a dopamine agonist therapy. Whether the drug is working will be assessed by evaluating clinical endpoints such as UPDRS scores and by evaluating images, obtained by SPECT scan, of brain activity. Participants in the study will be given either placebo or GPI 1485 treatment. The duration of the study is 2-years and patients are required to complete 12 safety visits and 3 SPECT scans. SPECT scans will be taken before, after 1-year, and after 2-years of treatment with GPI 1485. In completing the SPECT scan, patients will be injected with a radioactive investigational drug b-CIT and pictures taken using a Single Photon Emission Computed Tomography (SPECT) camera.

Conditions

Interventions

DRUG

GPI 1485

Sponsors & Collaborators

  • Symphony Neuro Development Company

    collaborator INDUSTRY

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Antonella Favit-Van Pelt, MD, PhD · Eisai Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2002-11-30
Completion
2005-10-31

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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 NCT00209508 on ClinicalTrials.gov