Apomorphine Nasal Powder in the Treatment of Parkinson's Disease "Off" Periods.

This study is not yet open for participant recruitment.

Verified by Britannia Pharmaceuticals Ltd., June 2006

First Received: June 29, 2006 No Changes Posted

Sponsor:	Britannia Pharmaceuticals Ltd.
Information provided by:	Britannia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:	NCT00346827

Purpose

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

Condition	Intervention	Phase
Parkinson's Disease	Drug: Apomorphine Nasal Powder	Phase II Phase III

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Apomorphine Apomorphine hydrochloride

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346827

Sponsors and Collaborators

Britannia Pharmaceuticals Ltd.

Investigators

Principal Investigator:

Richard Weiser, MB, MRCP

Swansea Hospital, Swansea, Wales

More Information

No publications provided

Study ID Numbers:	20102D05
Study First Received:	June 29, 2006
Last Updated:	June 29, 2006
ClinicalTrials.gov Identifier:	NCT00346827 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: Medicines Evaluation Board (MEB); Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Antiparkinson Agents
Dopamine Agonists
Brain Diseases

Neurodegenerative Diseases
Apomorphine
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010