Apomorphine Nasal Powder in the Treatment of Parkinson's Disease "Off" Periods.
July 8, 2019 updated by: Britannia Pharmaceuticals Ltd.
To determine the safety and tolerability of repeated dosing with Apomorphine Nasal Powder in subjects with Parkinson's Disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Sequential Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Weiser, MB, MRCP, Swansea Hospital, Swansea, Wales
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2006
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
June 29, 2006
First Submitted That Met QC Criteria
June 29, 2006
First Posted (Estimate)
June 30, 2006
Study Record Updates
Last Update Posted (Actual)
July 10, 2019
Last Update Submitted That Met QC Criteria
July 8, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Gastrointestinal Agents
- Dopamine Agonists
- Dopamine Agents
- Emetics
- Apomorphine
Other Study ID Numbers
- 20102D05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.