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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 baseline visit to treatment weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all treatment extension period visits
Awards & highlights

INFUS-ON Trial Summary

This trial will test a continuous infusion of a drug to treat advanced Parkinson's Disease when other treatments don't work.

Eligible Conditions
  • Parkinson's Disease

INFUS-ON Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit to treatment weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all treatment extension period visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline visit to treatment weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all treatment extension period visits for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Clinical Global Impression of Severity (CGI-S) and Change (CGI-C) Scale
Frequency and total dose of average daily intermittent injection APOKYN for subjects on APOKYN treatment at study entry
Parkinson's Disease Questionnaire
+8 more

Side effects data

From 2017 Phase 3 trial • 107 Patients • NCT02006121
47%
Infusion site nodule
20%
Nausea
19%
Somnolence
15%
Infusion site erythema
14%
Dyskinesia
13%
Insomnia
11%
Dizziness
10%
Headache
8%
Infusion site haematoma
8%
Vomiting
7%
Nasopharyngitis
7%
Oedema peripheral
7%
Back pain
6%
Fatigue
6%
Urinary tract infection
6%
Arthralgia
6%
Hallucination, visual
6%
Sleep disorder
6%
Orthostatic hypotension
5%
Dyspepsia
5%
Eosinophilia
5%
Electrocardiogram QT prolonged
5%
Infusion site pruritus
5%
Hallucination
2%
Fall
2%
Infusion site cellulitis
1%
Constipation
1%
Autoimmune haemolytic anaemia
1%
Deep brain stimulation
1%
Umbilical hernia
1%
Neuroleptic malignant syndrome
1%
Confusional state
1%
Haematocrit decreased
1%
Pneumonia
1%
Urinary retention
1%
Delirium
1%
Pulmonary embolism
1%
Haemoglobin decreased
1%
Red blood cell count decreased
1%
Hypotension
1%
Chest pain
1%
Angina pectoris
1%
Lower limb fracture
1%
Radius fracture
1%
Pathological fracture
1%
Lung neoplasm malignant
1%
Lower respiratory tract infection
1%
Diarrhoea
1%
Carotid artery stenosis
1%
Lymphopenia
1%
Myocardial infarction
1%
Colitis
1%
Blood disorder
1%
Gastrointestinal haemorrhage
1%
Cholelithiasis
1%
Forearm fracture
1%
Urosepsis
1%
Lymphoma
1%
Metastases to liver
1%
Parkinson's disease
1%
On Off phenomenon
1%
Paranoia
1%
Radicular syndrome
1%
Eosinophil count decreased
1%
Device difficult to use
1%
Infusion site extravasation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Apomorphine Hydrochloride
Placebo

INFUS-ON Trial Design

1Treatment groups
Experimental Treatment
Group I: Apomorphine infusionExperimental Treatment1 Intervention
Continuous subcutaneous apomorphine infusion

Find a Location

Who is running the clinical trial?

US WorldMeds LLCLead Sponsor
17 Previous Clinical Trials
1,298 Total Patients Enrolled
USWM, LLC (dba US WorldMeds)Lead Sponsor
22 Previous Clinical Trials
1,732 Total Patients Enrolled
MDD US Operations, LLC a subsidiary of Supernus PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
140 Total Patients Enrolled

Media Library

Apomorphine (Dopamine Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT02339064 — Phase 3
Parkinson's Disease Research Study Groups: Apomorphine infusion
Parkinson's Disease Clinical Trial 2023: Apomorphine Highlights & Side Effects. Trial Name: NCT02339064 — Phase 3
Apomorphine (Dopamine Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02339064 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the Apomorphine infusion procedure a safe treatment option for individuals?

"There is existing clinical data indicating Apomorphine infusion's safety, thus it has been given a score of 3."

Answered by AI

Are there further opportunities for participation in this clinical trial?

"The clinical trial in question is no longer enrolling patients, as evidenced by the information on clinicialtrials.gov which was last edited 8/8/2023. Nevertheless, there are still 529 other trials actively sourcing participants."

Answered by AI

Are there any antecedent research initiatives that have included Apomorphine infusion?

"In 2015, Apomorphine infusion was first evaluated in a clinical trial (NCT02339064). Since then, 20 studies have been completed and 3 new ones are still active. West Bloomfield, Michigan is one of the prime locations for these experiments."

Answered by AI

Has this type of medical experiment been undertaken before?

"Apomorphine infusion has been subject to clinical trials since 2015, with the first trial sponsored by MDD US Operations, LLC (a subsidiary of Supernus Pharmaceuticals). This Phase 3 drug was approved after its initial study involving 99 patients. Currently, there are three related studies being conducted across 16 cities and two different countries."

Answered by AI

How many areas in the state are hosting this experiment?

"This clinical trial is taking place at 16 medical hubs, including West Bloomfield, Aurora and Englewood. To reduce the burden of travel for participants, it may be wise to pick a clinic in close proximity."

Answered by AI

How many people are being recruited for this clinical research trial?

"This medical study is no longer actively recruiting. It was posted on February 1st 2015 and the most recent update occured on August 8th 2023. For individuals seeking out alternative trials, there are currently 526 clinical studies for Parkinson's disease and 3 Apomorphine infusion trials that remain open to applicants."

Answered by AI

Who else is applying?

What site did they apply to?
NCT02339064
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Infusion of Apomorphine: Long-term Safety Study
2015. "Infusion of Apomorphine: Long-term Safety Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02339064.
~10 spots leftby Apr 2025
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