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 up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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).

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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