CLINICAL TRIALS PROFILE FOR CONCERTA

All Clinical Trials for CONCERTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00151970 ↗	Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD	Completed	Noven Pharmaceuticals, Inc.	Phase 2	2005-06-01	This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
NCT00151970 ↗	Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD	Completed	Noven Therapeutics	Phase 2	2005-06-01	This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
NCT00069927 ↗	Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression	Terminated	National Cancer Institute (NCI)	Phase 2	2003-08-01	RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may help improve memory, attention, and thinking problems caused by central nervous system (CNS) treatment for cancer, and may help decrease depression. PURPOSE: This randomized phase II trial is studying dextroamphetamine-amphetamine to see how well it works compared to methylphenidate in treating depression and problems with memory, attention, and thinking in children who have undergone CNS treatment for cancer. This trial will also study how often depression is seen and if these medications might help.
NCT00069927 ↗	Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression	Terminated	University of South Florida	Phase 2	2003-08-01	RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may help improve memory, attention, and thinking problems caused by central nervous system (CNS) treatment for cancer, and may help decrease depression. PURPOSE: This randomized phase II trial is studying dextroamphetamine-amphetamine to see how well it works compared to methylphenidate in treating depression and problems with memory, attention, and thinking in children who have undergone CNS treatment for cancer. This trial will also study how often depression is seen and if these medications might help.
NCT00181571 ↗	A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	Phase 4	2003-06-01	This is a double-blind, placebo-controlled study using daily doses of up to 1.3 mg/kg/day of Concerta in the treatment of adults with the DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) (childhood onset). We hypothesize ADHD symptomatology in adults with DSM-IV ADHD will be responsive to Concerta treatment and Concerta-associated response of ADHD symptomatology in adults will be sustained over time.

Clinical Trial Conditions for CONCERTA

Condition Name

Condition Name for CONCERTA
Intervention	Trials
Attention Deficit Hyperactivity Disorder	28
ADHD	14
Attention Deficit Disorder With Hyperactivity	12
Healthy	6

Condition MeSH

Condition MeSH for CONCERTA
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	61
Hyperkinesis	40
Disease	24
Fatigue	6

Clinical Trial Locations for CONCERTA

Trials by Country

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Trials by Country for CONCERTA
Location	Trials
United States	172
Canada	7
Switzerland	3
Sweden	3
France	2

Trials by US State

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Trials by US State for CONCERTA
Location	Trials
Massachusetts	18
Ohio	13
Texas	11
New York	8
California	8

Clinical Trial Progress for CONCERTA

Clinical Trial Phase

Clinical Trial Phase for CONCERTA
Clinical Trial Phase	Trials
Phase 4	46
Phase 3	16
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for CONCERTA
Clinical Trial Phase	Trials
Completed	63
Unknown status	9
Terminated	6

Clinical Trial Sponsors for CONCERTA

Sponsor Name

Sponsor Name for CONCERTA
Sponsor	Trials
Massachusetts General Hospital	14
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	13
Ortho-McNeil Janssen Scientific Affairs, LLC	10

Sponsor Type

Sponsor Type for CONCERTA
Sponsor	Trials
Other	98
Industry	44
NIH	14

CONCERTA: Clinical Trials, Market Analysis, and Projections

Introduction

CONCERTA, a methylphenidate hydrochloride extended-release tablet, is a widely used medication for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Here, we will delve into the clinical trials that have established its efficacy, analyze the current market trends, and provide projections for its future in the ADHD market.

Clinical Trials and Efficacy

CONCERTA has been extensively evaluated in several clinical trials to establish its efficacy in treating ADHD.

Children and Adolescents

In children aged 6-12, CONCERTA was tested in three controlled trials, which included two single-center, 3-week crossover studies and one multicenter, 4-week parallel-group comparison. These studies demonstrated a statistically significant reduction in ADHD symptoms, as measured by the Inattention/Overactivity subscale of the IOWA Conners scale and the SKAMP laboratory school rating scale[4].

For adolescents aged 13-18, a randomized, double-blind, multi-center, placebo-controlled trial showed that CONCERTA significantly improved ADHD symptoms compared to placebo, as assessed by the ADHD Rating Scale and the Global Assessment of Effectiveness[4].

Adverse Reactions and Safety

Common adverse reactions in children and adolescents include abdominal pain, while in adults, decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decrease, irritability, and hyperhidrosis are more common. It is also important to monitor patients for the emergence or worsening of tics or Tourette’s syndrome[1].

Market Analysis

Current Market Status

The ADHD market, which includes CONCERTA, is experiencing mixed trends. The global ADHD market is projected to reach USD 13.6 billion by 2034, growing at a CAGR of 3.23% from 2024 to 2034. However, the market across the 7 major markets (7MM) is forecasted to decline at a negative CAGR of 0.9% from $11.9 billion in 2022 to $10.9 billion in 2032 due to patent expiries and the rise of generic alternatives[3][5].

Competitive Landscape

CONCERTA faces competition from both existing and emerging treatments. New pipeline agents such as Cingulate’s CTx-1301, Axsome Therapeutic’s solriamfetol hydrochloride, Otsuka’s centanafadine SR, and Neurocentria’s NRCT-101SR are expected to launch in the US market by 2026. These agents aim to differentiate themselves through increased duration of action and reduced side effects, rather than improved efficacy over current treatments[3].

Impact of Generics

The launch of generic versions of key ADHD medications, such as lisdexamfetamine dimesylate, is a significant barrier to market growth. Generic alternatives are often preferred due to their lower cost, which can limit the uptake of branded products like CONCERTA[3].

Market Projections

Sales and Market Share

Despite the overall decline in the ADHD market value, CONCERTA remains a significant player. However, its sales are expected to be impacted by the increasing availability of generic methylphenidate products. The market share of branded ADHD medications is anticipated to decrease as generics gain traction[3].

Growth Drivers

One of the key drivers for the ADHD market is the growing awareness and diagnosis of adult ADHD, which is expected to increase the number of treated cases. However, this growth is not expected to significantly benefit CONCERTA due to the preference for generic alternatives and the launch of new pipeline agents[3].

Key Takeaways

• Efficacy: CONCERTA has been proven effective in treating ADHD in children and adolescents through multiple clinical trials.
• Market Trends: The ADHD market is forecasted to decline in the 7MM due to patent expiries and the rise of generics.
• Competition: New pipeline agents and generic alternatives pose significant competition to CONCERTA.
• Growth Drivers: Growing awareness of adult ADHD could increase treated cases, but this may not significantly benefit branded products like CONCERTA.

FAQs

What are the common adverse reactions associated with CONCERTA?

Common adverse reactions in children and adolescents include abdominal pain, while in adults, they include decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decrease, irritability, and hyperhidrosis[1].

How does CONCERTA compare to other ADHD treatments in terms of efficacy?

CONCERTA has been shown to be effective in reducing ADHD symptoms in children and adolescents through several controlled clinical trials. However, new pipeline agents aim to offer improved duration of action and reduced side effects rather than enhanced efficacy[3][4].

What impact do generics have on the sales of CONCERTA?

The launch of generic methylphenidate products is expected to significantly impact the sales of CONCERTA, as generics are often preferred due to their lower cost[3].

Is CONCERTA indicated for adult ADHD?

While CONCERTA is primarily indicated for children and adolescents, it can be used in adults. However, the market for adult ADHD treatments is increasingly competitive, and generics may limit the uptake of branded products[1][3].

What are the projected market trends for the ADHD market?

The ADHD market across the 7MM is forecasted to decline at a negative CAGR of 0.9% from 2022 to 2032, despite a global market growth projection to USD 13.6 billion by 2034[3][5].

Sources

1. Concerta - accessdata.fda.gov
2. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025
3. 7MM ADHD market forecast to decline by $1bn between 2022 and 2032
4. CONCERTA® (methylphenidate HCl) Extended-release Tablets CII
5. Attention Deficit Hyperactivity Disorder Market Size to Reach USD 13.6 Billion by 2034