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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR RITALIN LA


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All Clinical Trials for Ritalin La

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00018863 ↗ Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS) Completed National Institute of Mental Health (NIMH) Phase 3 2001-04-01 This research focuses on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in very young children. The medication being used is methylphenidate (Ritalin); it is being studied to determine its safety and how well it works to treat ADHD in preschool-age children (3-5.5 year olds).
NCT00018863 ↗ Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS) Completed New York State Psychiatric Institute Phase 3 2001-04-01 This research focuses on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in very young children. The medication being used is methylphenidate (Ritalin); it is being studied to determine its safety and how well it works to treat ADHD in preschool-age children (3-5.5 year olds).
NCT00025779 ↗ Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders Completed National Institute of Mental Health (NIMH) N/A 2001-10-01 This study will evaluate the efficacy and safety of methylphenidate for treating hyperactivity, impulsiveness, and distractibility in 60 children and adolescents with Pervasive Developmental Disorders (PDD). Methylphenidate (Ritalin)is approved by the Food and Drug Administration for the treatment of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). Data supporting its safety and effectiveness in treating ADHD symptoms in PDD are limited. Children and adolescents who do not show a positive response to methylphenidate will be invited to participate in a pilot study of the non-stimulant medication guanfacine (Tenex).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ritalin La

Condition Name

Condition Name for Ritalin La
Intervention Trials
Attention Deficit Hyperactivity Disorder 26
Healthy 11
Attention Deficit Disorder With Hyperactivity 7
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Condition MeSH

Condition MeSH for Ritalin La
Intervention Trials
Attention Deficit Disorder with Hyperactivity 47
Hyperkinesis 35
Disease 24
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Clinical Trial Locations for Ritalin La

Trials by Country

Trials by Country for Ritalin La
Location Trials
United States 105
Israel 18
Canada 11
Switzerland 4
Netherlands 4
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Trials by US State

Trials by US State for Ritalin La
Location Trials
California 13
Texas 10
Massachusetts 10
Maryland 9
Ohio 8
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Clinical Trial Progress for Ritalin La

Clinical Trial Phase

Clinical Trial Phase for Ritalin La
Clinical Trial Phase Trials
Phase 4 37
Phase 3 14
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Ritalin La
Clinical Trial Phase Trials
Completed 67
Unknown status 20
Terminated 13
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Clinical Trial Sponsors for Ritalin La

Sponsor Name

Sponsor Name for Ritalin La
Sponsor Trials
Massachusetts General Hospital 8
National Institute of Mental Health (NIMH) 8
M.D. Anderson Cancer Center 6
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Sponsor Type

Sponsor Type for Ritalin La
Sponsor Trials
Other 164
NIH 23
Industry 15
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Clinical Trials and Efficacy of Ritalin LA

Ritalin LA, an extended-release formulation of methylphenidate, has undergone rigorous clinical trials to evaluate its safety and efficacy in treating Attention Deficit Hyperactivity Disorder (ADHD).

Clinical Trial Design and Outcomes

A key study involved a multicenter, double-blind, randomized, placebo-controlled, parallel-group trial. This study included children aged 6-14 years who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for ADHD. After a titration period and a 1-week placebo washout, patients were randomized to receive either Ritalin LA (10-40 mg/day) or placebo for 2 weeks. The primary efficacy variable was the change from baseline in the Conners' ADHD/DSM-IV Scales for teachers (CADS-T) Total subscale score[1].

The results showed that Ritalin LA significantly outperformed the placebo. The mean change from baseline in the CADS-T Total subscale score was -10.7 for Ritalin LA, compared to 2.8 for the placebo (p < 0.0001). Additionally, 69.8% of patients in the Ritalin LA group were rated as much or very much improved on the Clinical Global Impression-Improvement Scale (CGI-I), versus 40% in the placebo group (p = 0.0009)[1].

Adverse Reactions and Safety Profile

The clinical trials also assessed the safety profile of Ritalin LA. The most common adverse reactions reported were headache, insomnia, upper abdominal pain, decreased appetite, and anorexia. These adverse events were generally mild or moderate and similar in both the Ritalin LA and placebo groups. However, there were instances of discontinuation due to adverse events such as anger, hypomania, anxiety, and depressed mood[4].

Long-Term Safety Considerations

Long-term use of Ritalin LA requires careful monitoring for potential side effects, including increased intraocular pressure, motor and verbal tics, and the worsening of Tourette’s syndrome. Additionally, there is a concern about the long-term suppression of growth in pediatric patients[4].

Market Analysis and Projections for Ritalin LA

Market Size and Growth

The methylphenidate market, which includes Ritalin LA, has been experiencing significant growth. As of 2023, the market was valued at USD 6.3 billion and is projected to reach USD 7.7 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 10.8% from 2024 to 2031[2].

Key Market Drivers

Several factors are driving the growth of the methylphenidate market:

Increasing ADHD Prevalence

The rising awareness and diagnosis of ADHD among children and adults are significant drivers. Increased cases of ADHD lead to higher demand for medications like Ritalin LA[2][3].

Improved Awareness and Education

Enhanced awareness about ADHD and its treatment options among parents, healthcare providers, and the general public encourages more diagnoses and subsequent prescriptions of methylphenidate[2].

Pharmaceutical Advancements

Ongoing research and development in formulations, such as extended-release and sustained-release versions of methylphenidate, expand its appeal and usage, driving market growth[2].

Government Initiatives and Policies

Government initiatives and policies related to healthcare spending and mental health treatments also contribute to the market's growth[2].

Market Segmentation

The methylphenidate market can be segmented based on formulation type, route of administration, application, and geography.

Formulation Type

The LA formulation of methylphenidate, such as Ritalin LA, is designed to provide a bimodal release profile, with 50% of the dose released immediately and the remaining 50% released after a delay, resulting in two distinct peaks approximately 4 hours apart. This formulation is particularly popular due to its convenience and improved patient compliance[1][2].

Route of Administration

Oral formulations, including tablets and capsules, are the most common route of administration for methylphenidate. The LA formulation is favored for its ease of use and sustained release profile[2].

Geography

North America and Europe are significant segments of the methylphenidate market, driven by high prevalence rates of ADHD diagnoses and robust healthcare infrastructure. Emerging markets are also recognizing ADHD as a significant issue, driving demand in these regions[2].

Price Projections and Cost Analysis

Current Pricing

The cost of methylphenidate LA can vary based on the dosage, quantity, and pharmacy. For example, the cost for a 20 mg methylphenidate oral tablet, extended release, can range from $2.91 to $3.53 per unit, depending on the quantity and pharmacy[2].

Supply Chain and Availability

There have been recent supply chain issues affecting the availability of methylphenidate extended-release formulations, including Ritalin LA. Several manufacturers have reported backorders, with estimated release dates ranging from December 2024 to March 2025[5].

Key Takeaways

  • Efficacy and Safety: Ritalin LA has demonstrated statistically superior outcomes to placebo in clinical trials, with a favorable safety profile.
  • Market Growth: The methylphenidate market is expected to grow significantly, driven by increasing ADHD prevalence, improved awareness, and pharmaceutical advancements.
  • Convenience and Compliance: The LA formulation of methylphenidate offers a convenient and sustained release profile, enhancing patient compliance.
  • Regulatory and Safety Considerations: Long-term use requires careful monitoring for potential side effects, and regulatory challenges can impact market growth.
  • Supply Chain: Current supply chain issues may affect the availability of Ritalin LA and other methylphenidate formulations.

FAQs

1. What is the primary use of Ritalin LA?

Ritalin LA is primarily used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and, in some cases, narcolepsy[2].

2. How does the LA formulation of methylphenidate work?

The LA formulation provides a bimodal release profile, with 50% of the dose released immediately and the remaining 50% released after a delay, resulting in two distinct peaks approximately 4 hours apart[1][2].

3. What are the key drivers of the methylphenidate market?

Key drivers include increasing ADHD prevalence, improved awareness and education, pharmaceutical advancements, government initiatives, and rising healthcare expenditure[2][3].

4. How does the competitive landscape affect the methylphenidate market?

The presence of generic medications and competing products impacts pricing and market share, while longer-acting products have gained a significant share of the market[2][3].

5. What are the regulatory challenges facing the methylphenidate market?

Regulatory challenges include stringent mandates for controlled substances, potential safety concerns, and the need for careful monitoring of long-term side effects[3][4].

Sources

  1. Efficacy and safety of Ritalin LA, a new, once daily, extended-release formulation of methylphenidate, in children with attention deficit hyperactivity disorder. PubMed.
  2. METHYLPHENIDATE LA Market Analysis and Financial Projection. Drug Patent Watch.
  3. Methylphenidate Market Size, Share, Opportunities, Forecast 2030. Reports and Data.
  4. Ritalin LA - accessdata.fda.gov. FDA.
  5. Methylphenidate Extended Release Oral Presentations - ASHP. American Society of Health-System Pharmacists.

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