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Dopamine Agonist
Apomorphine Infusion for Parkinson's Disease (INFUS-ON Trial)
Phase 3
Waitlist Available
Research Sponsored by US WorldMeds LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Pivotal Trial
Approved for 5 Other Conditions
Summary
This trial will test a continuous infusion of a drug to treat advanced Parkinson's Disease when other treatments don't work.
Who is the study for?
This trial is for adults with advanced Parkinson's Disease who still have motor fluctuations despite treatment with levodopa and other therapies like dopamine agonists or MAO B inhibitors. Candidates must experience 'off' periods of at least 3 hours per day. People allergic to apomorphine, those with recent substance abuse, pregnant or lactating individuals, and patients with certain heart diseases or melanoma cannot participate.
What is being tested?
The study tests the safety and tolerability of continuous apomorphine infusion in participants. It's an open-label Phase 3 trial, meaning both researchers and participants know what treatment is being given, conducted across multiple centers.
What are the potential side effects?
Apomorphine infusion can cause nausea, low blood pressure upon standing (orthostatic hypotension), sleepiness, hallucinations, swelling due to fluid accumulation (edema), and impulsive behaviors. There may also be injection site reactions such as redness or pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Apomorphine infusionExperimental Treatment1 Intervention
Continuous subcutaneous apomorphine infusion
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Who is running the clinical trial?
US WorldMeds LLCLead Sponsor
17 Previous Clinical Trials
1,242 Total Patients Enrolled
USWM, LLC (dba US WorldMeds)Lead Sponsor
22 Previous Clinical Trials
1,676 Total Patients Enrolled
MDD US Operations, LLC a subsidiary of Supernus PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
140 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction to apomorphine hydrochloride or any other ingredients in APOKYN PFS.You have had problems with drinking or using drugs in the past year.You have a history of doing things without thinking, especially when taking certain types of medication.You are planning to have surgery for Parkinson's disease while taking part in the study.You have advanced Parkinson's Disease diagnosed using specific clinical criteria.Your motor control is not good enough, even with different treatments like levodopa and other medications. You have "off" periods that last at least 3 hours each day.You have had or currently have malignant melanoma.You show certain signs and symptoms of heart or blood vessel problems.You have had surgery to use a medication called levodopa/carbidopa intestinal gel (Duopa, Duodopa).You have received deep brain stimulation (DBS).Your doctor believes your overall ability to control movement is not good, even though you are taking the best available treatments, including levodopa and other medications.
Research Study Groups:
This trial has the following groups:- Group 1: Apomorphine infusion
Awards:
This trial has 4 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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