Cataplexy Narcolepsy, Excessive Daytime Sleepiness, Narcolepsy
Conditions
Brief summary
This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2 or placebo for 4-weeks.
Interventions
DRUGmazindol extended release
Dosed orally, once daily for up to 3 weeks
DRUGPlacebo
Dosed orally, once daily for up to 4 weeks.
Sponsors
NLS Pharmaceutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Males and females between 18 and 65 years of age, inclusive * Diagnosis of narcolepsy according to ICSD-3 (International Classification of Sleep Disorders, 3rd Edition) or Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria * Body mass index from 18 to 40 kg/m2, inclusive * Consent to use a medically acceptable method of contraception * Willing and able to provide written informed consent Key
Exclusion criteria
* Female subjects who are pregnant, nursing, or lactating * Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness * History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria * Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness * Use of any medications that could affect the evaluation of cataplexy * Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ESS Score From Baseline to Week 4 | Baseline to Week 4 | Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 4. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 4 | Baseline to Week 4 | Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 4. PGIc is rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse |
Countries
United States
Outcome results
None listed