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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

Confirmed Parkinson's Disease

Levodopa responsiveness for at least 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 26

Awards & highlights

Study Summary

This trial looks at using gene therapy to treat Parkinson's Disease symptoms by delivering a gene to a certain area of the brain.

Who is the study for?

This trial is for people with confirmed Parkinson's Disease who have responded to Levodopa treatment for at least a year and have moderate to severe symptoms when not medicated. It's not suitable for those with past brain surgery, atypical Parkinson’s, significant medical or psychiatric issues, previous brain infections or injuries, noticeable one-sided neurological problems, or cognitive impairment.Check my eligibility

What is being tested?

The study tests the safety of two doses of a gene therapy called AAV-GAD delivered directly into a part of the brain affected by Parkinson's. Participants are randomly assigned to receive either the actual gene therapy or a pretend surgery without active treatment.See study design

What are the potential side effects?

Potential side effects may include reactions related to brain surgery such as headache, nausea, bleeding or infection. The gene therapy could also cause immune responses since it uses a virus (AAV) to carry the GAD gene into cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Parkinson's Disease.

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I have responded to Levodopa treatment for over a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Parkinson Disease

Other outcome measures

Pharmaceutical Preparations

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: AAV-GAD Dose 2 treatment groupExperimental Treatment1 Intervention

Eligible participants will receive bilateral infusion of AAV-GAD Dose 2 into the STN

Group II: AAV-GAD Dose 1 treatment groupExperimental Treatment1 Intervention

Eligible participants will receive bilateral infusion of AAV-GAD Dose 1 into the STN

Group III: Sham treatment groupPlacebo Group1 Intervention

Eligible participants will undergo a sham surgical procedure

0 / 2Eligibility criteria met

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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: NCT05603312 — Phase 1 & 2

Parkinson's Disease Research Study Groups: AAV-GAD Dose 1 treatment group, AAV-GAD Dose 2 treatment group, Sham treatment group

Parkinson's Disease Clinical Trial 2023: AAV-GAD Highlights & Side Effects. Trial Name: NCT05603312 — Phase 1 & 2

AAV-GAD (Gene Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05603312 — Phase 1 & 2

Frequently Asked Questions

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

Are there any opportunities to participate in this experiment currently?

"Data hosted on clinicaltrials.gov confirms that this medical research is currently recruiting participants, with the protocol firstly shared and subsequently revised in October 2022."

Answered by AI

Who meets the criteria for participation in this investigation?

"The researchers of this trial are seeking 12 people living with [Parkinson's disease](https://www.withpower.com/clinical-trials/parkinson's-disease), aged between 25 and 85. To qualify for the study, applicants must have medically confirmed PD, be subject to levodopa protocols in the past year, and have a Unified Parkinson’s Disease Rating Scale (UPDRS) Part 3 score of at least 25 points when their medication is “off”."

Answered by AI

Is the eligibility for this experiment limited to people under 40?

"The parameters for this medical trial necessitate that participants are aged 25 to 85. Additionally, there are 27 studies specifically targeting those under 18 and 480 experiments focusing on individuals over 65 years old."

Answered by AI

Could you provide the aggregate amount of participants in this clinical experiment?

"Affirmative. According to the records available on clinicaltrials.gov, this research trial is currently enrolling participants. It was first advertised on October 5th 2022 and its parameters were most recently updated at the end of that same month. The study requires 12 people from two separate medical settings."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants

2022. "A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05603312.