A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease

Phase 1

Conditions: Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease
MedDRA version: 8.1Level: LLTClassification code 10061536Term: Parkinson's disease

Registration Number: EUCTR2006-000391-32-GB

Lead Sponsor: Britannia Pharmaceuticals Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 130

Inclusion Criteria

At Screening Visit:

1. Ability and willingness to give written informed consent

2. Males and females aged 18 years and over

3. History of Parkinson’s disease for at least 1 year prior to screening

4. Documented medication for Parkinson’s disease for at least 6 months prior to screening

5. Currently on established, stable treatment for Parkinson’s disease (i.e. unchanged in the last 4 weeks)

6. Subjects naïve to subcutaneous apomorphine therapy. Subjects who have undergone apomorphine challenge for diagnostic purposes (but who have not used subcutaneous apomorphine therapy) may be included.

7. At least one documented predictable or unpredictable daily acute episode of Parkinsonian motor symptoms (’off’ episode) that persists for longer than 30 minutes and resolves the same day

8. Willingness to take oral domperidone as anti-emesis prophylaxis for the duration of the blinded phase of the study and if required during open label

9. Willingness to agree not to change the dose of their usual Parkinsonian medication for the duration of blinded phase (except in the event of an emergency such as hospitalisation)

10. Ability to communicate well with the Investigator and comply with the requirements of the study

At Baseline Visit:

1. Ability to complete the diary card satisfactorily

At Visit 1:

1. One documented predictable or unpredictable daily acute episode of Parkinsonian motor symptoms (’off’ episode) that persists for longer than 30 minutes and resolves the same day - as demonstrated by the mean duration of the monitored acute episode of motor symptoms for the last 6 days in the completed Screening and Baseline diary cards, respectively

2. No clinically significant abnormal laboratory values or ECG findings which the Investigator considers would make the subject unsuitable for the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

At Screening and Baseline Visit:

1. Participation in any clinical study within the 12 weeks prior to screening

2. Subjects with respiratory depression, dementia, psychotic disease or hepatic insufficiency

3. Subjects with known hypersensitivity to apomorphine, its derivatives or any excipients of the product (mannitol and ascorbic acid)

4. Subjects who have an ‘on’ response to levodopa, which is marred by severe dyskinesia or dystonia

5. Pregnant or lactating females, or those likely to become pregnant

Additional Advice: The Investigator should exercise caution when administering apomorphine to subjects:

·With renal, pulmonary or cardiovascular disease
·Prone to nausea and vomiting
·If elderly or debilitated
·With pre-existing cardiac disease or taking vasoactive medicinal products
·With Postural hypotension
·Who have neuropsychiatric disturbances

Apomorphine has been associated with somnolence, therefore subjects who experience somnolence must refrain from driving or operating machines.
Coombs positive haemolytic anaemia has been reported in patients treated with levodopa. Haematology tests will therefore be performed regularly during the study.
Women of child bearing potential entered into the the study should be using adequate contraception and instructed to inform the Investigator if at any time they suspect they are pregnant or intend to become pregnant.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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