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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 (pre-altropane) and within 60 minutes after imaging.
Awards & highlights
Study Summary
This trial will see if a lower dose of Altropane can be used to image Parkinson's, instead of the current recommended dose.
Who is the study for?
This trial is for adults who suspect they have Parkinson's disease. Participants must be willing to follow study rules and use effective birth control if of childbearing potential. They should not have thyroid diseases, cognitive impairments, or recent drug/alcohol abuse, and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests whether a lower dose (5 millicuries) of Altropane is effective for imaging in suspected Parkinson's patients compared to the previously used higher dose (8 millicuries).See study design
What are the potential side effects?
Potential side effects are not detailed here but may include reactions related to the injection such as pain at the injection site, allergic reactions to Altropane ingredients, or issues from lying supine during imaging.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre-altropane) and within 60 minutes after imaging.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-altropane) and within 60 minutes after imaging.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Striatal uptake
Secondary outcome measures
Adverse Events
Altropane-related Serious Adverse Events
Inter-reader agreement
+11 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Altropane (123I) InjectionExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Labcorp Corporation of America Holdings, IncIndustry Sponsor
18 Previous Clinical Trials
4,196 Total Patients Enrolled
FortreaIndustry Sponsor
9 Previous Clinical Trials
2,390 Total Patients Enrolled
Labcorp Drug Development IncIndustry Sponsor
16 Previous Clinical Trials
3,156 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It hasn't been too long since my last radioisotope procedure.I am 18 years old or older.I haven't taken any prohibited medications within 12 hours before my SPECT exam.I am using reliable birth control and my pregnancy test was negative.I am a man and will use birth control if my partner can have children.I am not pregnant, breastfeeding, and if capable of childbearing, I am using birth control.My DaTscan within the last year shows normal brain activity, matching my diagnosis.I cannot lie on my back for an hour.I have no thyroid issues except for well-managed hypothyroidism.I have a serious health issue, abnormal lab results, or an irregular heart test.
Research Study Groups:
This trial has the following groups:- Group 1: Altropane (123I) Injection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the sample size of participants in this research project?
"30 suitable participants are necessary for the success of this trial, which is being overseen by GE Healthcare with sites at Mayo Clinic in Rochester and UMMC in Jackson."
Answered by AI
Has the U.S. Food and Drug Administration officially sanctioned Altropane (123I) Injection?
"Our team at Power assigned Altropane (123I) Injection an overall safety rating of 2, as Phase 2 trials have provided evidence that this drug is safe but there are no clinical data yet demonstrating efficacy."
Answered by AI
Is the enrollment period still open for this research trial?
"Confirmed. Clinicaltrials.gov data suggests that this research is actively enrolling patients, with the initial posting date of April 28th 2023 and a recent update occasioned on April 18th 2023. 30 participants are required from 3 different sites."
Answered by AI
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