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Methylphenidate long-acting

Phase 3

Attention Deficit Hyperactivity Disorder | Small molecule | Psychiatry |Novartis AG|Last Updated: May 6, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

Methylphenidate long-acting · 1 trial · 1 indication

Phase 3 1
NCT00428792Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)Attention Deficit Hyperactivity Disorder
COMPLETED150 Analytics
PHASE3COMPLETED
Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)
Attention Deficit Hyperactivity DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population
Friday of each of the 2 treatment weeks

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.

Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population
Friday of each of the 2 treatment weeks

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.

Secondary Endpoints

Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating
Friday of each of the 2 treatment weeks
Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating
Friday of each of the 2 treatment weeks
Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating
Friday of each of the 2 treatment weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Very light breakfast (VLB) then standard breakfast (SB)EXPERIMENTALVery 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)EXPERIMENTALStandard 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.

Interventions

NameTypeDescription
Methylphenidate 20 mg long-acting capsulesDRUG -
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Eligibility Criteria

Age Range6 Years to 12 Years
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:Germany
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Frequently asked questions about Methylphenidate long-acting

What is Methylphenidate long-acting used for?

Methylphenidate long-acting is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It is a small molecule being developed by Novartis AG for this psychiatric condition. The drug is currently in Phase 3 clinical development, meaning it is investigational and has not yet been approved for use.

Who makes Methylphenidate long-acting?

Methylphenidate long-acting is being developed by Novartis AG, a pharmaceutical company traded on the stock exchange under the ticker symbol NVS. The drug is intended for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and is currently in Phase 3 clinical trials.

What phase is Methylphenidate long-acting in?

Methylphenidate long-acting is in Phase 3 clinical development for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It is an investigational drug, meaning it has not yet received regulatory approval. One Phase 3 trial has been completed, involving 150 participants.

What clinical trials is Methylphenidate long-acting in?

Methylphenidate long-acting has one completed Phase 3 clinical trial, identified as NCT00428792. This trial, titled "Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)," enrolled 150 participants in Germany. The study included children aged 6 years and older and was a controlled trial.

Is Methylphenidate long-acting FDA approved?

Methylphenidate long-acting is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for Attention Deficit Hyperactivity Disorder (ADHD). One Phase 3 trial has been completed, but the drug has not yet received regulatory approval from the FDA or any other health authority.