Methylphenidate for ADHD
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Must be taking: Methylphenidate
Disqualifiers: Non-ADHD, Smokers, Pregnant, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial is investigating how genetic differences in an enzyme called CES1 affect the way ADHD patients respond to the medication methylphenidate. The goal is to understand why some patients do not respond well or experience severe side effects. Methylphenidate (MPH) is a well-established treatment for ADHD, but not all patients respond to it, and some experience adverse reactions.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug Methylphenidate for ADHD?
Research shows that Methylphenidate, including its controlled-delivery forms like Metadate CD, is effective in reducing ADHD symptoms in children and adolescents. It has been found to be superior to placebo and comparable to immediate-release versions, providing better symptom control during the school day.12345
Is methylphenidate generally safe for humans?
How is the drug Methylphenidate unique for treating ADHD?
Methylphenidate, especially in its controlled-delivery form, is unique because it provides effective symptom control throughout the school day with just one dose, making it convenient for children and adolescents with ADHD. It is also available in a chirally pure form called dexmethylphenidate, which is effective at half the dose of regular Ritalin, potentially reducing side effects and drug interactions.134710
Eligibility Criteria
This trial is for young people aged 6-26 with a primary diagnosis of ADHD. It's open to those who have previously been part of MPH trials and are invited back for further study. Smokers, pregnant individuals, or those not considered healthy enough for MPH treatment by their doctors cannot participate.Inclusion Criteria
I am between 6 and 26 years old and have been diagnosed with ADHD.
For former participants of MPH trials to be invited back for PK procedures.
Exclusion Criteria
You were not diagnosed with ADHD as your main condition.
I am not a candidate for medication treatment with MPH for my ADHD, as decided by my doctors.
You currently smoke or are pregnant.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive methylphenidate and are monitored for pharmacokinetics and pharmacodynamics in relation to CES1 genetic variants
8 hours per session
Multiple sessions (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Methylphenidate (Other)
Trial OverviewThe trial is examining how genetic differences in an enzyme called CES1 affect the body's response to Methylphenidate (MPH), a common medication used to treat ADHD. The goal is to understand the link between CES1 gene variants and MPH effectiveness.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: MethylphenidateExperimental Treatment1 Intervention
Youth with ADHD
Methylphenidate is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Methylphenidate for:
- Attention Deficit Hyperactivity Disorder (ADHD)
- Narcolepsy
🇨🇦 Approved in Canada as Methylphenidate for:
- Attention Deficit Hyperactivity Disorder (ADHD)
- Narcolepsy
🇪🇺 Approved in European Union as Methylphenidate for:
- Attention Deficit Hyperactivity Disorder (ADHD)
- Narcolepsy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Icahn School of Medicine at Mount SinaiNew York, NY
University of FloridaGainesville, FL
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
University of FloridaCollaborator
Seattle Children's HospitalCollaborator
Children's Hospital Medical Center, CincinnatiCollaborator
References
Methylphenidate controlled-delivery capsules (EquasymXL, Metadate CD): a review of its use in the treatment of children and adolescents with attention-deficit hyperactivity disorder. [2018]Controlled-delivery methylphenidate (methylphenidate CD) [EquasymXL, Metadate CD], an oral stimulant, is approved in the US and EU to treat children aged>or=6 years who have been diagnosed with attention-deficit hyperactivity disorder (ADHD). Once-daily methylphenidate CD is generally well tolerated and effective in the treatment of children and adolescents with ADHD. Methylphenidate CD resulted in superior control of ADHD symptoms compared with osmotic release oral system (OROS) methylphenidate over a time period corresponding to that of an average school day in a laboratory classroom. In 3-week clinical trials conducted in a community setting, methylphenidate CD was superior to placebo and noninferior to methylphenidate immediate-release (IR) in the treatment of children and adolescents with ADHD. Thus, methylphenidate CD should be considered an important primary treatment on its own or in addition to behavioral and psychosocial interventions, for when a reduction in ADHD symptoms is required during the school day in preference to the evening.
Comparison of the clinical efficacy of twice-daily Ritalin and once-daily Equasym XL with placebo in children with Attention Deficit/Hyperactivity Disorder. [2018]To compare the efficacy and safety of two methylphenidate (MPH) formulations--once-daily modified-release MPH (EqXL, Equasym XL) and twice-daily immediate-release methylphenidate (MPH-IR, Ritalin)--and placebo in children with Attention Deficit/Hyperactivity Disorder (ADHD).
Dexmethylphenidate--Novartis/Celgene. Focalin, D-MPH, D-methylphenidate hydrochloride, D-methylphenidate, dexmethylphenidate, dexmethylphenidate hydrochloride. [2018]Celgene has developed a chirally pure form of methylphenidate (Ritalin), called dexmethylphenidate [d-methylphenidate, d-methylphenidate hydrochloride, d-MPH; Focalin]. The drug has been launched in the USA and is undergoing registration in Canada for the treatment of children with attention-deficit hyperactivity disorder (ADHD). Dexmethylphenidate is the single isomer version of racemic methylphenidate (Ritalin), which contains the active d isomer of Ritalin. Dexmethylphenidate acts via the inhibition of reuptake of norepinephrine and dopamine. Research is ongoing to further clarify the mode of therapeutic action in ADHD. Dexmethylphenidate was developed with the aim of reducing drug load, adverse events and drug interactions. Dexmethylphenidate provides effective management of attention-deficit hyperactivity disorder at half the dose of Ritalin. In April 2000, worldwide rights (excluding Canada) to dexmethylphenidate were granted to Novartis. Celgene has also granted Novartis rights to all related intellectual properties and patents. Novartis will fund all remaining development and marketing expenses required for regulatory approval and commercialisation of dexmethylphenidate. Crystaal Corporation, the marketing division of Biovail Corporation International, has exclusive Canadian marketing rights for all formulations of dexmethylphenidate. Novartis launched dexmethylphenidate (Focalin) in the USA during Q1 2002. It is available as a D-shaped tablet (2.5, 5 and 10 mg doses). Novartis had planned to use the tradename Ritadex, however the FDA recommended an alternative name due to potential prescribing errors with Ritalin. The finalized tradename to be used is Focalin. In July 2001, a new drug submission was filed with Canada's Therapeutic Products Programme for dexmethylphenidate in the treatment of attention-deficit disorder and attention-deficit hyperactivity disorder. Novartis is also developing an extended-release version of chirally pure dexmethylphenidate. Dexmethylphenidate has been found to be effective and well tolerated in clinical trials, involving a total of 684 children with ADHD and in 15 healthy adult volunteers. Dexmethylphenidate is a schedule II drug.
Spotlight on methylphenidate controlled-delivery capsules (Equasym XL, Metadate CD) in the treatment of children and adolescents with attention-deficit hyperactivity disorder. [2019]Controlled-delivery methylphenidate (methylphenidate CD) [Equasym XL, Metadate CD], an oral stimulant, is approved in the US and EU to treat children aged > or = 6 years who have been diagnosed with attention-deficit hyperactivity disorder (ADHD). Once-daily methylphenidate CD is generally well tolerated and effective in the treatment of children and adolescents with ADHD. Methylphenidate CD resulted in superior control of ADHD symptoms compared with osmotic release oral system (OROS) methylphenidate over a time period corresponding to that of an average school day in a laboratory classroom. In 3-week clinical trials conducted in a community setting, methylphenidate CD was superior to placebo and non-inferior to methylphenidate immediate-release in the treatment of children and adolescents with ADHD. Thus, methylphenidate CD should be considered an important primary treatment on its own or in addition to behavioural and psychosocial interventions, for when a reduction in ADHD symptoms is required during the school day in preference to the evening.
Symptom control in children and adolescents with attention-deficit/hyperactivity disorder on switching from immediate-release MPH to OROS MPH Results of a 3-week open-label study. [2022]The aim of this study was to assess the impact of switching from immediate-release (IR) methylphenidate (MPH) to OROS MPH (CONCERTA, a once-daily long-acting MPH formulation, in children and adolescents with attention-deficit/hyperactivity disorder (ADHD).
A postmarketing clinical experience study of Metadate CD. [2019]The objective of the study was to investigate the effectiveness and safety of Metadate CD (methylphenidate HCl, USP) Extended Release Capsules in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD), in actual clinical practice.
Efficacy and safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, double-blind, parallel group, dose-escalation study. [2022]To assess the efficacy and safety of OROS methylphenidate (Concerta; McNeil Pediatrics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, Titusville, NJ) in the management of attention-deficit/hyperactivity disorder (ADHD) in adults.
[Utilization of methylphenidate(Ritalin) in France]. [2013]Methylphenidate (Ritalin) is the only psychostimulant approved in France and indicated in attention deficit hyperactivity disorder in children over 6 years. It is under restricted prescription and distribution conditions. As such, it requires a hospital initiated prescription from either a neurology, psychiatry or pediatric specialist and it is covered by the "narcotics" schedule. The French Pharmacovigilance database spontaneous adverse drug reactions reporting, since it was approved in 1995, were analyzed. 21 adverse drug reactions were reported. In 16 cases, methylphenidate was suspected. They were generally non-serious, mild side effects and in most cases promptly resolved. These results do not suggest methylphenidate misuse in France or an overuse in between 1300 and 4000 treated children, to date. Until more information is available concerning the long-term effects of methylphenidate, and in order to limit misuse, inappropriate or overuse, the current prescription and dispensing regulation should be maintained in France, and could well be developed in other countries.
Adverse events in medication treatment-naïve children with attention-deficit/hyperactivity disorder: results from a small, controlled trial of lisdexamfetamine dimesylate. [2015]To evaluate the type, frequency, duration, and severity of treatment emergent adverse events (TEAEs) of the prodrug lisdexamfetamine dimesylate (LDX) in children with and without previous exposure to stimulant medication in the treatment of attention-deficit/hyperactivity disorder (ADHD).
The clinical impact of switching attention deficit hyperactivity disorder patients from OROS(®)-MPH to Novo-MPH ER-C(®): A paediatric practice review. [2021]In Canada, novo-methylphenidate extended-release capsules (Novo-MPH ER-C, Novopharm Limited, Canada) was approved as being bioequivalent to a current first-line treatment for attention deficit hyperactivity disorder (ADHD), CONCERTA (OROS-MPH, Janssen Inc, Canada). The present practice review was undertaken to determine whether bioequivalence of these products translates into therapeutic equivalence.