Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NT0102 · 1 trial · 1 indication
The primary efficacy endpoint was derived from the SKAMP-Combined score calculated as the total score of all 13 items of the SKAMP-Combined score. The SKAMP-Combined score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible score of 0 to 78. A lower score indicates less symptomatology (i.e., is better). The SKAMP was a rating scale that specifically measures the classroom manifestations of ADHD. The SKAMP ratings were completed for all subjects at baseline (pre-dose) and at 1, 3, 5, 7, 10, 12, and 13 hours post-dose on the classroom testing day (Visit 8). The primary analysis time point for the primary efficacy endpoint was the average of all post-dose SKAMP scores during the 13-hour period.
| Arm | Type | Description |
|---|---|---|
| NT0102 | EXPERIMENTAL | After the screening/washout period, all participants will receive study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug will be selected, and participants will stay on that dose for 1 week (dose stabilization period). At the end of this period, participants will be randomized to a treatment. Participants in this arm will be given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period. |
| Placebo | PLACEBO_COMPARATOR | After the screening/washout period, all participants will receive study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug will be selected, and participants will stay on that dose for 1 week (dose stabilization period). At the end of this period, participants will be randomized to a treatment. Participants in this arm will be given placebo as matching ODT once daily for one week during the double-blind treatment period. |
| Name | Type | Description |
|---|---|---|
| NT0102 | DRUG | NT0102 (methylphenidate polistirex \[MPP\] extended release \[XR\] ODT) was given once daily at a dose equivalent to 20-60 mg methylphenidate hydrochloride. |
| Placebo | DRUG | Matching ODT placebo was given once daily. |
Inclusion Criteria: * Currently being treated for ADHD Exclusion Criteria: * Other psychiatric diagnoses * Significant cognitive impairment * Chronic medical illnesses * Structural cardiac defects * Significant abnormal lab tests * Taking disallowed medications * Positive drug test
NT0102 is an investigational small molecule being developed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children. It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug is being studied in the United States.
The specific molecular target of NT0102 has not been disclosed in available information. It is classified as a small molecule therapeutic intended for the treatment of ADHD, but its mechanism of action is not publicly detailed.
NT0102 is being developed by Aytu BioPharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AYTU. The company is conducting clinical research to evaluate the drug's safety and efficacy in treating ADHD.
NT0102 is in Phase 3 clinical development. A Phase 3 trial has been completed, but the drug remains investigational and is not yet approved for commercial use. Further regulatory review and potential additional studies may be required before it can be marketed.
NT0102 has been studied in one completed Phase 3 clinical trial, identified as NCT01835548. This randomized, double-blind, placebo-controlled study enrolled 87 children aged 6 years and older with ADHD in the United States. The trial has been completed, and no active trials are currently listed.
No alternative names for NT0102 have been identified in available information. It is referred to solely by its development code NT0102 in clinical trial registrations and related documentation.