Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Mazindol, mazindol extended release
NLS-2 · 4 trials · 7 indications
Cataplexy episodes is a clinical outcome measure that assesses the frequency of cataplexy episodes.
Summaries of the number and percentage of subjects who experienced Treatment Emergent Adverse Events (TEAEs), TEAEs related to study drug, SAEs, or discontinued study drug or withdrew from the study due to an AE.
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.
| Arm | Type | Description |
|---|---|---|
| NLS-2 | EXPERIMENTAL | Participants will receive a single NLS-2 tablet orally once daily from Day 1 to Day 56 (until the end of Week 8). |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single NLS-2 placebo matching tablet orally once daily from Day 1 to Day 56 (until the end of Week 8). |
| NLS-2 (mazindol extended release) | EXPERIMENTAL | NLS-2 (mazindol extended release) administered once a day. |
| Mazindol Controlled Release | EXPERIMENTAL | Mazindol controlled release taken once daily. Dosage starting at 1 mg increasing or decreasing in increments of 1 mg depending on efficacy and tolerability. Maximum dose during the study is 3 mg taken once daily. |
| Name | Type | Description |
|---|---|---|
| NLS-2 | DRUG | Participants will receive NLS-2 tablets orally. |
| Placebo | DRUG | Participants will receive NLS-2 matching placebo tablets orally. |
| Mazindol | DRUG | Drug: NLS-2 |
| mazindol extended release | DRUG | Dosed orally, once daily for up to 3 weeks |
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 pr...
NLS-2 is an investigational small molecule being developed for the treatment of narcolepsy type 1, also known as narcolepsy with cataplexy. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
NLS-2 is a small molecule, but its specific molecular target has not been disclosed in available information. It is being studied for its effects on symptoms of narcolepsy type 1, including excessive daytime sleepiness and cataplexy.
NLS-2 is being developed by NewcelX Ltd., a biopharmaceutical company. The company is conducting a Phase 3 clinical trial to evaluate the drug's safety and efficacy in patients with narcolepsy type 1.
NLS-2 is currently in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval for any indication. The ongoing Phase 3 trial is designed to assess its effects in participants with narcolepsy type 1.
NLS-2 is being evaluated in a Phase 3 clinical trial registered as NCT05914194. This eight-week study is a randomized, double-blind, placebo-controlled trial enrolling approximately 48 participants aged 18 years and older with narcolepsy type 1 or narcolepsy with cataplexy.
NLS-2 is described as mazindol extended release in the clinical trial title. It is a formulation of mazindol designed for extended release, being studied for the treatment of narcolepsy type 1.