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

NCT ID: NCT00346827

Last Updated: 2019-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Intervention Model

SEQUENTIAL

3-week, double-blind, placebo-controlled, 3 × crossover efficacy phase followed by 12 week open label phase, followed by 36 week open continuation phase
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Apomorphine Nasal Powder

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Britannia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Richard Weiser, MB, MRCP

Role: PRINCIPAL_INVESTIGATOR

Swansea Hospital, Swansea, Wales

Other Identifiers

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20102D05

Identifier Type: -

Identifier Source: org_study_id

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