Single-Centre Study of VR040(Inhaled Apomorphine) in Idiopathic Parkinson's Disease
NCT ID: NCT01683292
Last Updated: 2012-09-11
Study Results
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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COMPLETED
PHASE2
29 participants
INTERVENTIONAL
2006-01-31
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Inhaled VR040
Inhaled apomorphine, dry powder, VR040 at fine particle doses (FPD) of 0.2mg, 0.5mg and 0.8mg. A single dose, followed by a second dose at 12 minutes if efficacy end point was not attained.
Inhaled VR040
Placebo
Inhaled dry powder. A single dose, followed by a second dose at 12 minutes if efficacy end point was not attained.
Placebo for VR040
Placebo arm
Interventions
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Inhaled VR040
Placebo for VR040
Placebo arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with a modified Hoehn and Yahr disease severity scoring of between 2 and 4 in an "on" state.
3. Men or women aged over 30 years.
4. Patients with a signed and dated written valid consent obtained prior to participation.
5. Female patients must have been of non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who was post-menopausal) or of child-bearing potential with a negative pregnancy test (urine or serum) at screening.
6. Patients who experienced motor fluctuations with recognisable "off" periods in control of motor symptoms, as assessed by the motor fluctuation questionnaire (patients were to have reported at least 1 "Yes" response to the questions in the motor fluctuation questionnaire).
7. Patient willing and able to comply with study procedures.-
Exclusion Criteria
2. Patients with serious uncontrolled disease including serious psychological disorders likely to interfere with the study and/or likely to cause death within 6 months of the study completion.
3. Patients with previous intolerance to apomorphine.
4. Patients with a previous significant complication from oral dopamine agonist therapy including hospitalisation following dopamine agonist introduction and/or the development of hallucinations or other adverse neuropsychiatric features following introduction of sc apomorphine.
5. Women lactating, pregnant, or of child-bearing potential not using a reliable contraceptive method.
6. Patients with known HIV or active chronic hepatitis B or C infection.
7. Patients with any clinically significant abnormality following review of screening laboratory data and full physical examination.
8. Patients who, in the Investigator's opinion, were unsuitable for the study for any reason.
9. Patients with clinically significant blood test abnormalities and previous medical history/intercurrent illnesses that may have compromised the safety of the patient in the study.
10. Patients with major ECG abnormalities (as judged by the Investigator).
11. Patients with a FEV1 \<65%.
12. Patients showing a postural decrease in systolic blood pressure (BP) of \> 20 mm Hg, or showing significant clinical symptoms associated with orthostatic hypotension.
13. Patients with persistent elevation of BP, with average systolic readings of 160 mm Hg or average diastolic readings of 100 mm Hg.
14. Patients taking anabolic steroids, traditional antipsychotics (unless low dose), and antiemetics other than domperidone.
15. Patients taking agents of the 5HT3 antagonist class including ondansetron, granisetron, dolasetron, palonosetron, and alosetron.
16. Patients with existing cancer and those in remission for less than 5 years.
17. Patients with evidence (as ascertained from examination, tests or history) to indicate cardiovascular, gastrointestinal tract, liver, kidney, central nervous system, pulmonary system, or bone marrow disorders that in the Investigator's opinion compromised patient safety.
18. Patients who were known non-responders to apomorphine treatment for "off" episodes.
19. Patients with a history of drug or alcohol abuse in the 12 months prior to entry.
20. Patients with a history of clinically significant allergies to VR040 formulation constituents (including lactose and opioids) and domperidone.
21. Patients with signs or symptoms suggestive of schizophrenia, dementia, "Parkinson plus" syndromes, or unstable systemic disease
30 Years
ALL
No
Sponsors
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Vectura Limited
INDUSTRY
South Glasgow University Hospitals NHS Trust
OTHER
Responsible Party
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Dr Donald Grosset
Consultant Neurologist
Locations
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Southern General Hospital
Glasgow, , United Kingdom
Countries
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Other Identifiers
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VR040/001
Identifier Type: -
Identifier Source: org_study_id