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Gene Therapy

Gene Therapy for Parkinson's Disease

Phase 1 & 2
Waitlist Available
Research Sponsored by MeiraGTx, 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 from study start until month 60 post treatment
Awards & highlights

Study Summary

This trial tests if a gene therapy can safely help people with Parkinson's in the long-term.

Who is the study for?
This trial is for participants who were previously enrolled in Study MGT-GAD-025. There are no additional exclusion criteria, meaning that past participants of the mentioned study can join regardless of other conditions.Check my eligibility
What is being tested?
The trial is studying the long-term safety of a gene therapy called AAV-GAD, which was given to patients with Parkinson's disease by injecting it into a part of the brain known as the subthalamic nuclei (STN).See study design
What are the potential side effects?
Since this is a follow-up study focusing on long-term safety, specific side effects aren't listed. However, potential side effects may relate to gene therapy and could include immune reactions or symptoms worsening.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study start until month 60 post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study start until month 60 post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with study drug-related adverse events and serious adverse events

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Active treatment groupExperimental Treatment1 Intervention
Participants who were randomized to sham surgery in Study MGT-GAD-025 will transition to an active treatment schedule including open-label bilateral treatment upon confirmation of continued eligibility. Upon completion of the treatment period, participants will enter the long-term follow-up schedule to complete a total of 60 months of follow-up.
Group II: Follow-up groupActive Control1 Intervention
Participants who were randomized to immediate treatment in Study MGT-GAD-025 will transition directly to a long-term follow-up schedule to complete an additional 54 months of follow-up. All study participants are to be followed for a period of 60 months after vector administration.

Find a Location

Who is running the clinical trial?

MeiraGTx, LLCLead Sponsor
4 Previous Clinical Trials
175 Total Patients Enrolled

Media Library

AAV-GAD (Gene Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05894343 — Phase 1 & 2
Parkinson's Disease Research Study Groups: Follow-up group, Active treatment group
Parkinson's Disease Clinical Trial 2023: AAV-GAD Highlights & Side Effects. Trial Name: NCT05894343 — Phase 1 & 2
AAV-GAD (Gene Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05894343 — Phase 1 & 2

Frequently Asked Questions

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

What are the criteria for enrolment in this clinical trial?

"Qualified applicants for this trial should have been diagnosed with Parkinson's disease and must be between the ages of 25 and 86. The organisers aim to recruit a total of 14 participants."

Answered by AI

Are researchers currently accepting participants for this trial?

"According to the clinicaltrials.gov page, this study has already concluded its recruitment process and is no longer seeking participants - last update was on June 7th 2023. Despite that, there are plenty of other medical studies currently enrolling 510 patients in total."

Answered by AI

Is senior citizen participation encouraged in this experiment?

"This medical study exclusively seeks individuals aged 25 to 86. However, there are 24 trials dedicated to adolescents and 507 for seniors over the age of 65."

Answered by AI

How many establishments within the city are currently running this experiment?

"This medical trial offers 5 recruitment sites including Weill Cornell Medicine in New york, Columbia University Irving Medical Center in Philadelphia and Thomas Jefferson University in Morgantown. Furthermore, there are a handful of other locales where patients may be considered for enrolment."

Answered by AI
~9 spots leftby May 2028