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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2006 by Britannia Pharmaceuticals Ltd.. Recruitment status was Not yet recruiting

First Received on 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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind

Resource links provided by NLM:

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

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Apomorphine Apomorphine hydrochloride Apomorphine hydrochloride anhydrous

U.S. FDA Resources

Further study details as provided by Britannia Pharmaceuticals Ltd.:

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

ClinicalTrials.gov Identifier:	NCT00346827 History of Changes
Other Study ID Numbers:	20102D05
Study First Received:	June 29, 2006
Last Updated:	June 29, 2006
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:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Apomorphine
Antiparkinson Agents

Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012