A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1

Launched by NLS PHARMACEUTICS · Jun 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called NLS-2 (mazindol extended-release) to see how well it helps people with Narcolepsy Type 1, especially with symptoms like excessive daytime sleepiness and cataplexy, which is a sudden loss of muscle control. The trial will include about 48 adults from across the United States who are at least 18 years old and have a confirmed diagnosis of Narcolepsy Type 1. Participants need to be able to stop taking certain medications for narcolepsy and have a body mass index (BMI) between 18 and 40.

The treatment will last for 8 weeks, during which some participants will receive NLS-2 while others will receive a placebo (a non-active pill). After this period, everyone may have the chance to join another study where they will all receive NLS-2. It’s important to note that certain health issues, like significant heart problems or a history of seizures, may prevent someone from participating. This trial is not yet recruiting, so interested individuals should keep an eye out for updates.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Adults ≥ 18 years of age at the time of signing the informed consent.
• • Documented primary diagnosis of Narcolepsy Type 1 (NT1) according to the International Classification of Sleep Disorders-Third Edition (ICSD-3) criteria.
• • Willing and able to safely discontinue all prohibited medications, including medications for the treatment of narcolepsy.
• • Body Mass Index (BMI) within the range of 18 - 40 kg/m2 (inclusive).
• Key Exclusion Criteria:
• • Any other (besides narcolepsy) clinically relevant medical, behavioral, or psychiatric disorder that is associated with excessive daytime sleepiness or cataplexy.
• • History of myocardial infarction or significant cardiovascular disease, structural cardiac abnormalities, cardiomyopathy, congestive heart failure, cardiac arrhythmias, coronary artery disease, cerebrovascular disease (transient ischemic attack or stroke), or any other significant cardiac problem.
• • History of long QT Syndrome or Torsades de Pointes, or an immediate family history of sudden cardiac death.
• • History of pulmonary hypertension and/or valvulopathy.
• • History of epilepsy, convulsions, or seizures (excluding early childhood febrile seizures).
• • Significant history of head injury or head trauma.
• • Recent or active suicidal ideation or behavior
• • Current, or within the past year, diagnosis of substance abuse or dependence disorder (SUD) including alcohol abuse.
• • Narrow-angle glaucoma.
• • Severe renal or hepatic insufficiency.
• • Occupation that requires variable or nighttime shift work.