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Methylphenidate long-acting · 1 trial · 1 indication
The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.
The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.
| Arm | Type | Description |
|---|---|---|
| Very light breakfast (VLB) then standard breakfast (SB) | EXPERIMENTAL | Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 1 or 2 20 mg capsules of methylphenidate once per day based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. |
| Standard breakfast (SB) then very light breakfast (VLB) | EXPERIMENTAL | Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 1 or 2 20 mg capsules of methylphenidate once per day based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. |
| Name | Type | Description |
|---|---|---|
| Methylphenidate 20 mg long-acting capsules | DRUG | - |
Inclusion Criteria: * Children aged 6-12 * Diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD) * Current medication with either 20 mg or 40 mg immediate release methylphenidate Exclusion Criteria: * Concomitant psychiatric disorders requiring pharmacological treatment * Concomitant sever...
Methylphenidate long-acting is used to treat Attention Deficit Hyperactivity Disorder (ADHD). It is a long-acting formulation of methylphenidate, a small molecule developed by Novartis AG (ticker: NVS). The drug is currently in Phase 3 clinical development for ADHD.
Methylphenidate long-acting targets SLC6A3 and SLC6A2. It acts as an inhibitor of these targets. SLC6A3 is the dopamine transporter and SLC6A2 is the norepinephrine transporter. By inhibiting these transporters, the drug increases dopamine and norepinephrine levels in the brain, which helps improve attention and reduce impulsivity in ADHD.
Methylphenidate long-acting is developed by Novartis AG, which trades under the ticker NVS. Novartis is the company responsible for the clinical development of this long-acting methylphenidate formulation for ADHD.
Methylphenidate long-acting is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 3 trial for this drug has been completed.
Methylphenidate long-acting has been studied in one completed Phase 3 clinical trial: NCT00428792, titled "Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)." This trial enrolled 150 children aged 6 years and older in Germany. It was a randomized, controlled trial.