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Gene Therapy

Gene Therapy for Epilepsy

Phase 1 & 2

Recruiting

Research Sponsored by uniQure France SAS

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult, 18-65 years of age, capable of giving informed consent

Diagnosis of unilateral refractory MTLE for ≥360 days, confirmed by an Epilepsy Monitoring Unit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial studies an investigational drug for adults with epilepsy. It will assess safety, tolerability, and effectiveness of the drug delivered via MRI-guided injection into the brain.

Who is the study for?

Adults aged 18-65 with unilateral refractory mesial temporal lobe epilepsy, having at least 2 seizures per month and on stable anti-seizure drugs. They must have normal cognitive function, no major unrelated neurosurgery history, and agree to use birth control. MRI-compatible devices are okay if implanted over 3 months ago.Check my eligibility

What is being tested?

The trial tests AMT-260 gene therapy for safety and effectiveness in reducing seizures in adults with MTLE. It involves injecting the treatment directly into the brain using MRI-guided techniques while monitoring patients' responses.See study design

What are the potential side effects?

Potential side effects aren't specified but may include typical risks associated with gene therapies such as immune reactions, headaches or discomfort from the delivery method (MRI-guided injection), and general anesthesia-related risks.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old and can make my own medical decisions.

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I have been diagnosed with hard-to-treat epilepsy in one side of my brain for over a year.

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I have had at least 2 seizures a month in the last 3 months.

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My cognitive function score is 26 or higher.

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My brain function is normal and matches my MRI and PET scan results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Adverse Events

Secondary outcome measures

AAV9 vector in human biofluid (copies/qPCR reaction).

Patient Health Questionnaire (PHQ9)

Pittsburgh Sleep Quality Index (PSQI)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2: AMT-260 adapted doseExperimental Treatment1 Intervention

N# of treated - 6 Dose is dependent on the DSMB recommendation.

Group II: Cohort 1: AMT-260 starting doseExperimental Treatment1 Intervention

N# of treated - 6

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

uniQure France SASLead Sponsor

Andreas BortaStudy DirectoruniQure France SAS

Frequently Asked Questions

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

Are new participants being recruited for this trial?

"As indicated on clinicaltrials.gov, the recruitment period for this medical trial has ended as it was last updated on September 25th 2023 and first posted a month prior. However, there are still 247 other trials that are actively seeking participants."

Answered by AI

Would I meet the criteria to join this clinical trial?

"The prerequisites for enrolment in this medical trial are mesial temporal lobe epilepsy and an age between 18 to 65. Our team is hoping to enroll 12 participants by the end of the study."

Answered by AI

Are elderly adults in their eighties being included as participants of this research?

"According to the eligibility requirements of this trial, only patients aged 18-65 may register. For those younger than 18 or older than 65 there are 106 and 164 trials respectively for them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy

2023. "AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06063850.