Phase 1 Sleep Disorders Trial, Recruiting NCT07216066 Sponsor: Regeneron Pharmaceuticals Condition: Sleep Disorders
Back to Sleep Disorders

Phase 1 Sleep Disorders Trial, Recruiting

NCT07216066
Recruiting Phase 1

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 Parkinson's disease according to a specific medical standard, where the diagnosis includes slowness of movement plus at least one other main sign (such as tremor at rest or muscle stiffness), with no other known cause for the condition
  • People who received their Parkinson's disease diagnosis 4 years ago or less at the time of the screening visit
  • People who are either not currently taking any standard Parkinson's medication (including levodopa, dopamine agonists, or MAO-B inhibitors) and are not expected to need such medication for around 6 months after receiving the study treatment — OR — people who have been on a stable Parkinson's medication routine for at least 3 months before the study treatment and are not expected to need dose changes for around 6 months afterward
  • People with a body mass index (a measure of weight relative to height) of 35 or below at the time of the screening visit

Who may not be able to join:

  • People whose medical history suggests a Parkinson's-like condition other than Parkinson's disease itself
  • People with significant heart, lung, liver, kidney, digestive, hormonal, blood, psychiatric, or neurological conditions (other than Parkinson's disease) that the trial doctor believes could affect study results or raise safety concerns
  • People with a history of brain or spinal disease or injury that could interfere with a lumbar puncture (a procedure to collect fluid from around the spine) or the flow of that fluid
  • People for whom a brain MRI scan is not medically appropriate
  • People with a known allergy or sensitivity to lidocaine, a local anaesthetic
  • People who have previously had a bad reaction to an injection into the spinal fluid
  • People with a current history of bleeding or clotting problems that would increase the risk of bleeding during a lumbar puncture
  • People who have previously had gene therapy, cell therapy, or surgery for Parkinson's disease, including deep brain stimulation

Important: These are not all of the trial's eligibility criteria. 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 20 July 2026
Phase 1: approximately ~10% 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 Trial Management, Regeneron Pharmaceuticals

Phone: 844-734-6643

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 1
Sponsor
Regeneron Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
5 December 2025
Est. completion
7 June 2029

Where this trial is recruiting

🇨🇦 Canada 🇳🇱 Netherlands

Primary endpoints

Occurrence of Treatment-Emergent Adverse Events (TEAEs); Severity of TEAEs

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: 20 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