Back to resultsApomorphine Nasal Powder in the Treatment of Parkinson's Disease "Off" Periods.
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Apomorphine Nasal Powder
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria: 1 year history of Parkinson's Disease; stable PD medications for 4 weeks; at least one documented "off" period per day Exclusion Criteria: hypersensitivity to apomorphine; participation in a clinical trial in the last 12 weeks; pregnant or lactating females
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00346827
First Posted
June 29, 2006
Last Updated
July 8, 2019
Sponsor
Britannia Pharmaceuticals Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00346827
Brief Title
Apomorphine Nasal Powder in the Treatment of Parkinson's Disease "Off" Periods.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 2006 (Actual)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Britannia Pharmaceuticals Ltd.
4. Oversight
5. Study Description
Brief Summary
To determine the safety and tolerability of repeated dosing with Apomorphine Nasal Powder in subjects with Parkinson's Disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Sequential Assignment
Model Description
3-week, double-blind, placebo-controlled, 3 × crossover efficacy phase followed by 12 week open label phase, followed by 36 week open continuation phase
Masking
ParticipantInvestigator
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Apomorphine Nasal Powder
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1 year history of Parkinson's Disease; stable PD medications for 4 weeks; at least one documented "off" period per day
Exclusion Criteria:
hypersensitivity to apomorphine; participation in a clinical trial in the last 12 weeks; pregnant or lactating females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Weiser, MB, MRCP
Organizational Affiliation
Swansea Hospital, Swansea, Wales
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Apomorphine Nasal Powder in the Treatment of Parkinson's Disease "Off" Periods.
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