NCT00346827

Brief Summary

To determine the safety and tolerability of repeated dosing with Apomorphine Nasal Powder in subjects with Parkinson's Disease.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

June 29, 2006

Last Update Submit

July 8, 2019

Conditions

Parkinson's Disease

Interventions

Apomorphine Nasal PowderDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year history of Parkinson's Disease; stable PD medications for 4 weeks; at least one documented "off" period per day

You may not qualify if:

  • hypersensitivity to apomorphine; participation in a clinical trial in the last 12 weeks; pregnant or lactating females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Richard Weiser, MB, MRCP

    Swansea Hospital, Swansea, Wales

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 3-week, double-blind, placebo-controlled, 3 × crossover efficacy phase followed by 12 week open label phase, followed by 36 week open continuation phase
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 29, 2006

First Posted

June 30, 2006

Study Start

July 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

July 10, 2019

Record last verified: 2019-07