Long Term Safety and Efficacy of SC Apomorphine in Treatment of "Off" Episodes in Late-Stage Parkinson's Disease

Inclusion Criteria

• •Prior participation in a MYLAN sponsored study of subcutaneous apomorphine administration for the treatment of Off episodes due to end-of-dose motor deterioration ("Wearing-Off" effect) or sudden loss of mobility at seemingly random intervals ("On-Off" effect). With prior approval from MYLAN, patients other than those enrolled in a MYLAN sponsored study were allowed to participate. Following approval of Amendment 01, patients who met all other criteria for inclusion, regardless of previous participation in an apomorphine study, were allowed to participate.
• •Age: Adults of any age \> 18.
• •Sex: Men and non-pregnant, non-lactating women.
• •Women of childbearing potential must have had a negative serum (Beta HCG) pregnancy test within 14 days of the study start.
• •Women of childbearing potential must have used an acceptable form of contraception.
• •Patients with a clinical diagnosis of idiopathic Parkinson's Disease, i.e., not induced by drugs or caused by other diseases.
• •Patients classified as stage II - V of the Hoehn and Yahr scale for staging the severity of Parkinson's Disease.
• •Patients with refractory motor fluctuations of any frequency or duration. These include but are not necessarily limited to patients with the following symptoms:
• •* Immobility resulting from regular dose failures.
• •* Severe Off period discomfort.
• •* Nocturnal/early morning dystonias.
• •* Voiding dysfunctions.
• •* Swallowing difficulties associated with Off periods.
• •* Off period visual hallucinations.
• •* Severe biphasic dyskinesia.
• •The patient (or a caregiver) had to be able to recognize an Off state, and be sufficiently motivated to learn how to use the apomorphine injection to control these periods.
• •The patient (or a caregiver) had to be able to maintain On-Off diaries.
• •Unless otherwise specified, enrolled patients must be on an optimally maximized oral therapy regimen. Optimized oral anti-PD medication included: levodopa/carbidopa in either immediate or delayed release forms, plus at least one direct acting oral dopamine agonist for at least 30 days prior to enrollment into study.