Single-Centre Study of VR040(Inhaled Apomorphine) in Idiopathic Parkinson's Disease

Exclusion Criteria

• •1. Patients who had participated in a trial with an investigational product within 3 months prior to randomisation at Visit 2.
• •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