Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mazindol · 3 trials · 6 indications
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 (mazindol extended release) | EXPERIMENTAL | NLS-2 (mazindol extended release) administered once a day. |
| Placebo | PLACEBO_COMPARATOR | Dosed orally, once daily for up to 4 weeks |
| 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 |
|---|---|---|
| Mazindol | DRUG | Drug: NLS-2 |
| mazindol extended release | DRUG | Dosed orally, once daily for up to 3 weeks |
| Placebo | DRUG | Dosed orally, once daily for up to 4 weeks. |
Inclusion Criteria: * The subject must complete all Study NLS-1021 study requirements and assessments up to Visit 6; * The subject is able, in the opinion of the Investigator, to receive NLS-2 for the 24-week Treatment Phase of this study; * Biological females of childbearing potential must agree t...
Mazindol is being developed for attention deficit disorder with hyperactivity and for narcolepsy with cataplexy. NewcelX Ltd. is studying an extended-release formulation of the small molecule in adults. Both programs are in Phase 2 clinical development, so mazindol is investigational and has not been approved for these uses.
NewcelX Ltd., which trades under the ticker NCEL, is developing mazindol. The company is advancing an extended-release formulation of the small molecule across two Phase 2 programs, one in attention deficit disorder with hyperactivity and one in narcolepsy with cataplexy.
Mazindol is in Phase 2 clinical development. NewcelX Ltd. has completed Phase 2 studies in attention deficit disorder with hyperactivity and in narcolepsy with cataplexy. No Phase 3 trial has been registered, and mazindol remains investigational for these indications.
Two completed Phase 2 trials are registered for mazindol. NCT02808104 tested mazindol controlled release in 84 adults with attention deficit disorder with hyperactivity in the United States. NCT05055024 was an open label study of NLS-2, mazindol extended release, in 52 subjects with narcolepsy, including narcolepsy with cataplexy.
NLS-2 is the extended-release formulation of mazindol that NewcelX Ltd. is developing. The Phase 2 narcolepsy study NCT05055024 is titled as a study of NLS-2 (mazindol extended release), so the two names refer to the same investigational product.
The Phase 2 trial NCT02808104 was a randomized, double-blind, placebo-controlled study of mazindol controlled release in 84 adults with attention deficit disorder with hyperactivity. It enrolled participants aged 18 years and older of any sex in the United States and has been completed.