NT0102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)

Neos Therapeutics

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Treatments: Drug: NT0102; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01835548

NT0102.1004

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled, parallel group, Phase 3 trial to evaluate the safety and efficacy of NT0102 in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age in a laboratory classroom study.

Enrollment: 87 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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87 participants in 2 patient groups, including a placebo group

NT0102

Experimental group

Description:

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.

Treatment:

Drug: NT0102

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo