Phase 2 Multiple Sclerosis Trial, Recruiting NCT06063850 Sponsor: UniQure Biopharma B.V. Condition: Multiple Sclerosis
Back to Multiple Sclerosis

Phase 2 Multiple Sclerosis Trial, Recruiting

NCT06063850
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with a specific type of epilepsy called mesial temporal lobe epilepsy (MTLE) that affects only one side of the brain and has not responded to medication.
  • People who have had at least 2 seizures per month (of specific types — either seizures involving loss of awareness, or seizures that spread to affect the whole body) on average over the past 3 months, with records to confirm this.
  • People who have been on a stable type and dose of up to 4 approved seizure medications for at least 1 month before that 3-month period.
  • People who have confirmed abnormality in one specific brain structure (the hippocampus) on only one side of the brain, with scan results that match where the seizures are coming from.
  • People whose thinking and memory difficulties, if any, are consistent with what their brain scans show — and not unexpectedly different from what the disease would explain.
  • People who are able and willing to use highly effective contraception consistently throughout the study (applies to women who could become pregnant and men who could father a child).
  • Women who could become pregnant must have a negative pregnancy test before joining.

Who may not be able to join:

  • People who have an implanted device (such as a pacemaker) that is not safe for MRI scans, or whose MRI-compatible device was implanted less than 3 months before the screening visit (devices like vagus nerve stimulators may be considered on a case-by-case basis by the trial doctor).
  • People who have any medical reason that would make general anaesthetic, surgery, or MRI during surgery unsafe.
  • People taking certain medications (for example, some antipsychotic or antiviral drugs) that could interfere with test results, affect safety, or affect the ability to undergo the surgical procedure or follow the trial schedule.
  • People whose epilepsy affects both sides of the brain, multiple areas, or whose doctors cannot clearly identify which side the seizures start from.
  • People who have dementia or other progressive neurological conditions, or a brain lesion that is growing or worsening.
  • People who have previously had major brain surgery unrelated to their epilepsy (such as for a brain tumour, head injury, or bleeding), or who have previously had brain surgery to treat epilepsy (note: diagnostic depth electrode monitoring is not counted as an exclusion).
  • People whose MRI scans show seizure-related abnormalities outside the temporal lobe, or abnormalities in both temporal lobes.
  • People who have had a prolonged, dangerous seizure episode (status epilepticus) within the year before the screening visit.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Development Lead, uniQure France SAS

Phone: 1-866-520-1257

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
UniQure Biopharma B.V.
Registry
ClinicalTrials.gov
Start date
12 June 2024
Est. completion
30 November 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To evaluate the safety and tolerability of AMT-260 in adults with unilateral refractory MTLE.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov