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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00142545
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : September 2, 2005
Sponsor:
Information provided by:
Mylan Bertek Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 31, 2005
First Posted Date  ICMJE September 2, 2005
Last Update Posted Date September 2, 2005
Study Start Date  ICMJE July 1999
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
  • adverse events (AE)s
  • clinical laboratory tests
  • vital signs
  • electrocardiogram
  • orthostatic monitoring
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
  • • Hoehn and Yahr Score
  • • UPDRS score - Motor Exam (Section III)
  • • UPDRS score - Total
  • • UPDRS score - Non-Motor Exam (Subtotal of Sections I, II, and IV)
  • • UPDRS score - Complications of Therapy (Section IV)
  • • Number of Off episodes based diary entries
  • • Duration of Off episodes based on diary entries
  • • Number of daily injections based on diary entries
  • • Length of time from injection to On based on diary entries
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Safety and Efficacy of SC Apomorphine in Treatment of "Off" Episodes in Late-Stage Parkinson's Disease
Official Title  ICMJE Long-Term Safety and Effectiveness of Subcutaneous Injections of Apomorphine in the Treatment of "Off" Episodes in Patients With "On-Off" or "Wearing-Off" Effects Associated With Late-Stage Parkinson's Disease
Brief Summary The current protocol is designed to satisfy the need for a compassionate use treatment protocol as well as for a long-term open label follow-up study.
Detailed Description The primary objective of APO401 was to gain additional safety data in the outpatient use of apomorphine. APO401 provided an opportunity for all patients who had participated in a Mylan-sponsored placebo controlled trial of apomorphine to receive apomorphine therapy as ambulatory outpatients. Patients other than those enrolled in a Mylan-sponsored study were allowed to participate. Additional data regarding the safety and effectiveness of outpatient use of subcutaneous apomorphine were derived from this experience.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE Drug: apomorphine HCl injection
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 31, 2005)		 800
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE July 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Exclusion Criteria:

  • Patients under medical therapy for clinically significant psychoses or dementia not related to ingestion of anti-PD medications. (Patients with hallucinations or other central adverse reactions associated solely with anti-PD medications were not excluded.)
  • Patients with a history of drug or alcohol dependency within one year prior to study enrollment.
  • 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.
  • Patients with a history of true allergy to morphine or its derivatives (including apomorphine), sulfur, sulfur containing medication, sulfites, sulfates, Tigan(R) (trimethobenzamide).
  • Patients treated with experimental agents (other than apomorphine intermittent subcutaneous injections) within 30 days before study entry. Patients with participation in Bertek-sponsored study APO202 were excluded from participation in this study.
  • Patients whose apomorphine regimen was characterized by administration methods other than intermittent subcutaneous injection.
  • Patients who could not or would not sign an Informed Consent form.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00142545
Other Study ID Numbers  ICMJE APO401
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mylan Bertek Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Will Sullivan Mylan Bertek Pharmaceuticals
PRS Account Mylan Bertek Pharmaceuticals
Verification Date July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP