CLINICAL TRIALS PROFILE FOR METADATE CD

All Clinical Trials for METADATE CD

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02482649 ↗	EAA/Therapy for Treating Children With ADHD	Unknown status	Samsung Electronics	N/A	2013-01-01	The aim of this study is 1) to investigate clinical effects of equine-assisted activities and therapy (EAA/T) for treating attention-deficit/hyperactivity disorder (ADHD) and 2) to compare the clinical effect of EAA/T and drug therapy in children 6-13-years-of-age. This study is designed as a 12-week, prospective, open labeled trial, including 24 sessions of EAA/T. Forty six subjects will be enrolled and various clinical tests will be administered at baseline and after EAA/T or drug therapy.
NCT01100658 ↗	Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors	Terminated	Children's Cancer Research Fund United States	N/A	2010-05-01	While neurocognitive impairments in attention, memory and executive functioning are commonly reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to examine the treatment of attention deficits in this population. Numerous studies have examined the effectiveness of methylphenidate in the treatment of children with attention deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for improving attention and behavioral functioning in children with medical illnesses or brain injury are less clear. Patients will be randomized to receive one week of Metadate CD (a controlled release form of methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.
NCT01100658 ↗	Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors	Terminated	University of Minnesota	N/A	2010-05-01	While neurocognitive impairments in attention, memory and executive functioning are commonly reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to examine the treatment of attention deficits in this population. Numerous studies have examined the effectiveness of methylphenidate in the treatment of children with attention deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for improving attention and behavioral functioning in children with medical illnesses or brain injury are less clear. Patients will be randomized to receive one week of Metadate CD (a controlled release form of methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.
NCT01100658 ↗	Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors	Terminated	University of Minnesota - Clinical and Translational Science Institute	N/A	2010-05-01	While neurocognitive impairments in attention, memory and executive functioning are commonly reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to examine the treatment of attention deficits in this population. Numerous studies have examined the effectiveness of methylphenidate in the treatment of children with attention deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for improving attention and behavioral functioning in children with medical illnesses or brain injury are less clear. Patients will be randomized to receive one week of Metadate CD (a controlled release form of methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.
NCT00301639 ↗	A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy Of Two Long-Acting Formulations of Methylphenidate in Adults	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	Phase 3	2005-03-01	The specific aim of this study is to document the pharmacokinetics of dopamine transporter DAT receptor occupancy of OROS MPH and Metadate CD using PET scanning with C-11 Altropane as the ligand. We hypothesize that CNS DAT occupancy of OROS MPH will be greater than that of Metadate CD at 10 hours after administration.
NCT00301639 ↗	A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy Of Two Long-Acting Formulations of Methylphenidate in Adults	Completed	Massachusetts General Hospital	Phase 3	2005-03-01	The specific aim of this study is to document the pharmacokinetics of dopamine transporter DAT receptor occupancy of OROS MPH and Metadate CD using PET scanning with C-11 Altropane as the ligand. We hypothesize that CNS DAT occupancy of OROS MPH will be greater than that of Metadate CD at 10 hours after administration.
NCT00381758 ↗	The COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting	Completed	UCB Pharma	Phase 4	2002-05-01	This study was designed to compare Concerta Extended Release tablets with Metadate CD capsules in children with ADHD who were between 6 and 12 years old. The effects on ADHD symptoms, and any side effects of treatment, were measured for 12 hours after dosing in a simulated classroom. The treatments were blinded and the effects were compared with a Placebo.

Clinical Trial Conditions for METADATE CD

Condition Name

Condition Name for METADATE CD
Intervention	Trials
Attention Deficit Hyperactivity Disorder	3
Cocaine Use Disorder	1
Lymphoblastic Leukemia, Acute	1
Healthy Volunteers	1

Condition MeSH

Condition MeSH for METADATE CD
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	4
Hyperkinesis	2
Acute Disease	1
Problem Behavior	1

Clinical Trial Locations for METADATE CD

Trials by Country

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−

Trials by Country for METADATE CD
Location	Trials
United States	4
Korea, Republic of	1

Trials by US State

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−

Trials by US State for METADATE CD
Location	Trials
Kentucky	1
Iowa	1
Minnesota	1
Massachusetts	1

Clinical Trial Progress for METADATE CD

Clinical Trial Phase

Clinical Trial Phase for METADATE CD
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
N/A	2

Clinical Trial Status

Clinical Trial Status for METADATE CD
Clinical Trial Phase	Trials
Completed	3
Unknown status	1
Recruiting	1

Clinical Trial Sponsors for METADATE CD

Sponsor Name

Sponsor Name for METADATE CD
Sponsor	Trials
Samsung Medical Center	1
Matthew J O'Brien, PhD, BCBA-D	1
Matthew O'Brien	1

Sponsor Type

Sponsor Type for METADATE CD
Sponsor	Trials
Other	8
Industry	3
NIH	1

Metadate CD: Clinical Trials, Market Analysis, and Projections

Introduction to Metadate CD

Metadate CD, also known as methylphenidate hydrochloride extended-release capsules, is a central nervous system (CNS) stimulant primarily used to treat Attention Deficit Hyperactivity Disorder (ADHD). This medication combines both immediate-release (IR) and extended-release (ER) components to provide a sustained therapeutic effect throughout the day[2].

Pharmacological Profile

Metadate CD works by blocking the reuptake of norepinephrine and dopamine into the presynaptic neuron, thereby increasing the release of these monoamines into the extraneuronal space. This mechanism helps in reducing symptoms of ADHD such as inattention, hyperactivity, and impulsivity[2].

Clinical Trials and Efficacy

Postmarketing Clinical Experience Study

A postmarketing clinical experience study evaluated the effectiveness and safety of Metadate CD in actual clinical practice. The study involved 308 patients aged 6-17 with a diagnosis of ADHD. Patients were administered Metadate CD once daily for 3 weeks, with doses titrated against reported and observed symptoms. The results showed that 65% of the patients demonstrated a positive response to Metadate CD, defined by a Clinical Global Impression (CGI) Global Improvement rating of very much or much improved. Most patients (87%) were very satisfied or moderately satisfied with the study treatment, and 71% of previously treated patients rated Metadate CD as much better or better than their previous methylphenidate treatment[1].

Controlled Clinical Trials

In a double-blind, parallel-group, placebo-controlled trial, 321 untreated or previously treated pediatric patients with ADHD received a single morning dose of Metadate CD for up to 3 weeks. The trial showed that patients treated with Metadate CD had a statistically significant improvement in ADHD symptoms compared to those who received a placebo. The treatment effect was observed in both the morning and the afternoon, indicating the sustained efficacy of the medication[4].

Market Analysis and Projections

Market Size and Growth

The methylphenidate drug market, which includes Metadate CD, is projected to grow significantly. From 2021 to 2028, the market is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.17%. This growth is driven by several factors, including the increasing prevalence of ADHD, government support for mental health initiatives, and the preference for effective and affordable generic ADHD medications[2].

Segmentation Analysis

Product Segmentation

The market is bifurcated into tablets and capsules. While tablets dominate the market share, capsules like Metadate CD are gaining traction due to their convenience and sustained-release formulation[2].

Application Segmentation

The market is divided into children (6-17 years) and adults. The adult segment holds the largest share, reflecting the high prevalence of ADHD among adults. However, the pediatric segment is also significant, given the increasing diagnosis and treatment of ADHD in children[2].

Geographical Segmentation

North America dominates the global market, accounting for more than 68% of the total market share. This dominance is attributed to the high volume of drug prescriptions, new product launches, and collaborative efforts among market players[2].

Pricing and Cost Analysis

Current Pricing

The cost of Metadate CD capsules varies based on the dosage and quantity. For example, a 30-capsule supply of 10 mg/24 hr extended-release capsules can cost around $640, with each capsule priced at approximately $21.34[2].

Generic Versions

Generic versions of methylphenidate are available and significantly cheaper. For instance, a 100-capsule supply of generic methylphenidate can cost between $278.89 and $300, depending on the pharmacy and location[2].

Safety and Adverse Events

Adverse Events in Clinical Trials

In clinical trials, adverse events associated with Metadate CD were consistent with the current FDA-approved product labeling. Common adverse events included headache, abdominal pain, and dizziness. In the 3-week placebo-controlled trial, two Metadate CD-treated patients discontinued due to adverse events such as rash, pruritus, and headache[4].

Serious Cardiovascular Events

There is a risk of sudden blood pressure increase during surgery, and Metadate CD should not be taken on the day of surgery. Additionally, CNS stimulants like Metadate CD should not be used in children or adolescents with known serious structural cardiac abnormalities due to the risk of sudden death[4].

Market Challenges

Despite the positive market projections, the methylphenidate market faces several challenges, including side effects, regulatory issues, and supply shortages. These factors can impact the availability and affordability of Metadate CD and other methylphenidate products[2].

Key Takeaways

• Market Growth: The methylphenidate drug market is expected to grow at a CAGR of 7.17% from 2021 to 2028.
• Pricing: The cost of Metadate CD is around $640 for a 30-capsule supply, with generic versions available at significantly lower prices.
• Efficacy: Metadate CD has been shown to be effective in treating ADHD symptoms in both clinical trials and postmarketing studies.
• Safety: Adverse events are consistent with FDA-approved labeling, but serious cardiovascular events and other risks need to be considered.

FAQs

1. What is Metadate CD used for?

Metadate CD is used primarily to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adults[2].

2. How does Metadate CD work?

Metadate CD works by blocking the reuptake of norepinephrine and dopamine into the presynaptic neuron, increasing the release of these monoamines and reducing ADHD symptoms[2].

3. What are the common adverse events associated with Metadate CD?

Common adverse events include headache, abdominal pain, and dizziness. Serious cardiovascular events are also a concern, especially in patients with structural cardiac abnormalities[4].

4. Is Metadate CD available in generic form?

Yes, generic versions of methylphenidate are available and are significantly cheaper than the brand name Metadate CD[2][3].

5. What is the market outlook for Metadate CD?

The methylphenidate market, including Metadate CD, is expected to grow at a CAGR of 7.17% from 2021 to 2028, driven by increasing ADHD prevalence and government support for mental health initiatives[2].

Sources

1. PubMed: A postmarketing clinical experience study of Metadate CD.
2. Drug Patent Watch: Market Analysis and Financial Projection for Methylphenidate CD.
3. PR Newswire: Impax Launches Generic Version of Metadate CD.
4. FDA Label: METADATE CD (methylphenidate HCl, USP) Extended-Release Capsules.
5. Drugs.com: Generic Metadate CD Availability.