Methylphenidate: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Methylphenidate appears in the FDA drug-label database. Marketed as Methylphenidate.
- Drug class
- Central Nervous System Stimulant (FDA established pharmacologic class)
- Boxed warning
- The FDA label for Methylphenidate carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Methylphenidate transdermal system is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Limitations of Us e The use of methylphenidate transdermal system is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.8) , Use in Specific Populations (8.4) ] . Methylphenidate transdermal system is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. ( 1 ) Limitations of Use The use of methylphenidate transdermal system is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.8 , 8.4 ).
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values. — Noven Pharmaceuticals, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2016-08-22 |
| Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained. — Noven Pharmaceuticals, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2014-02-13 |
| Defective Delivery System: One lot exceeded the mechanical peel specification — Noven Pharmaceuticals, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2015-01-12 |
| Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration. — Noven Pharmaceuticals, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2015-12-21 |
| Defective Delivery System: Out of specification for z-statistic related to mechanical peel force. — Noven Pharmaceuticals, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2015-07-27 |
Phase breakdown
Conditions being studied
Recruiting trials involving Methylphenidate
- Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder
- Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD
- Combination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer
- Efficacy of Reboxetine and Methylphenidate Treatment on Attentional, Sensory and Emotional Dysregulation in Adults With PTSD
- Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes
- Metabolic Mechanisms of the Electrophysiological Biomarkers for Response to Methylphenidate Treatment in Children With ADHD
- Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits
- Methylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints
- Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD
- Psilocybin in Chronic Low Back Pain and Depression
- Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
- rTMS for Apathy Clinical Trial
Common questions
Is Methylphenidate FDA-approved?
Yes, marketed as Methylphenidate. Its FDA label carries a boxed warning.
How many recruiting trials involve Methylphenidate?
12 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.