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PK, PD and Safety of Multiple Doses of V1512 Tablets in PD Patients Compared to Standard Levodopa/Carbidopa Oral Tablets

NCT00491998 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2011-07-25

No results posted yet for this study

Summary

The purpose of the study is to determine if the pharmacokinetic profile of V1512 is similar or better than existing medications for the treatment of Parkinson's Disease

Conditions

Interventions

DRUG

V1512

6 doses of IMP at 2-hourly intervals

DRUG

V1512

3-hourly dosing

DRUG

V1512 and Entacapone

4 doses of IMP and Entacapone at 3-hourly intervals

Sponsors & Collaborators

  • Cita NeuroPharmaceuticals

    collaborator INDUSTRY

  • Syneos Health

    collaborator OTHER

  • Vernalis (R&D) Ltd

    lead INDUSTRY

Principal Investigators

  • Fabrizio Stocchi, MD, PhD · IRCCS San Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00491998 on ClinicalTrials.gov