Parkinson DiseasePhase 3NCT00142545
Long Term Safety and Efficacy of SC Apomorphine in Treatment of "Off" Episodes in Late-Stage Parkinson's Disease
A Phase 3 study testing apomorphine HCl injection in people with Parkinson Disease, run by Mylan Bertek Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- apomorphine HCl injection
- Type of treatment
- Injection or infusion
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1999to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mylan Pharmaceuticals
Morgantown, West Virginia, 26505
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- apomorphine HCl injection
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apomorphine HCl injectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events (AE)s
clinical laboratory tests
vital signs
electrocardiogram
orthostatic monitoring
Secondary outcomes (9)
• 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startJul 1999
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants
Sponsor and investigators
- Lead sponsor
- Mylan Bertek Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Will Sullivan, Study director, Mylan Bertek Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142545
- Sponsor's protocol ID
- APO401
- Status last verified
- Jul 2005
- First submitted
- 31 Aug 2005
- Last updated
- 2 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00142545
- Acronym / sponsor ID
- APO401
- Conditions
- Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants
- Lead sponsor
- Mylan Bertek PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 1999
- Study completion
- Jul 2005
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apomorphine HCl injection | Drug | – |
Primary outcome
adverse events (AE)s
clinical laboratory tests
vital signs
electrocardiogram
orthostatic monitoring
9 secondary outcomes
• 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Will Sullivan study director
Mylan Bertek Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing apomorphine HCl injection in people with Parkinson Disease, run by Mylan Bertek Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (AE)s. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2005.