A Sub-Study With Patients in APO401 to Evaluate Adverse Events During Dose Introduction in Apomorphine-naïve Patients.

• Status: Completed
• Trial end date: 2002-08-01
• Target enrollment: 0
• Participant gender: All

Summary

APO303 is a sub-study of patients enrolled in APO401 (the long-term open label safety protocol) and was designed to evaluate adverse events, particularly blood pressure drops when standing up during first dose in patients who have not been exposed to apomorphine before.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mylan Bertek Pharmaceuticals
• Treatments: Apomorphine

Criteria

Inclusion Criteria:

1. Age: Adults of any age > 18.

2. Sex: Men and non-pregnant, non-lactating women.

1. Women of childbearing potential must have had a negative serum (Beta HCG) pregnancy test within 14 days of the study start.

2. Women of childbearing potential must have used an acceptable form of contraception

3. Patients with a clinical diagnosis of idiopathic Parkinson's disease, ie. not induced by drugs or caused by other diseases.

4. Patients classified as stage II - V of the Hoehn and Yahr scale for staging the severity of Parkinson's disease (Appendix 16.1.12.3).

5. Patients with refractory motor fluctuations of any frequency or duration. These included but are not necessarily limited to patients with the following symptoms:

1. Immobility resulting from regular dose failures.

2. Severe "Off" period discomfort.

3. Nocturnal/early morning dystonias.

4. Voiding dysfunctions.

5. Swallowing difficulties associated with "Off" periods.

6. "Off" period visual hallucinations.

7. Severe biphasic dyskinesia.

6. 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 other antiparkinson medication, which could include a direct acting oral dopamine agonist, a monoamine oxidase inhibitor (MAOB), or a catechol-O-methyltransferase inhibitor (COMT) for at least 30 days prior to enrollment into study.

7. Patients enrolled in APO401 who have completed initial baseline observations, but have not received apomorphine therapy as part of the APO401 protocol or at any other point in time.

Exclusion Criteria:

1. Patients with prior exposure to apomorphine, including prior participation in a Mylan sponsored study of subcutaneous apomorphine. Patients were enrolled in APO401 concurrently with APO303.

2. Patients who did not conform to all of the above inclusion criteria.

3. Patients under medical therapy for clinically significant psychoses or dementia.

4. Patients with a history of drug or alcohol dependency within one year prior to study enrollment.

5. Patients with unstable and clinically significant disease of cardiovascular (including orthostatic hypotension), hematologic (including Coombs' positive hemolytic anemia), hepatic, renal, metabolic, respiratory, gastrointestinal or endocrinological systems or neoplasm within the three months before the start of the study.

6. Patients on methyldopa therapy.

7. Patients with a history of true allergy to morphine or its derivatives, sulfur, sulfur containing medication, sulfites, trimethobenzamide or other anticholinergics.

8. Patients treated with other experimental agents within 30 days before study entry.