methylphenidate
methylphenidate: developed by 2 companies · 10 clinical trials tracked · 1 FDA decision.
methylphenidate evidence translation
What we can confirm
1 FDA record · 10 tracked trials
What it means
What to watch
Prepared research question
What is verified about methylphenidate, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence6 indications · 4 study sponsors
Related indications
Development Pipeline (2)
| Company | Phase |
|---|---|
| AYTU BIOPHARMA, INC (AYTU) treatment of attention deficit hyperactivity disorder (ADHD) | Approved |
| Neos Therapeutics, Inc. (NEOS) Treatment of ADHD in patients 6 to 17 years old | Approved |
Clinical Trials (10)
A Multimodal Imaging Study of Dopamine in Early Psychosis
Primary endpoint: Dopamine transmission
Use of JornayPM® to Treat ADHD in Pediatric Epilepsy
Primary endpoint: Clinical Global Impression-Improvement
A Phase 1, Single Blind, Parallel-arm Trial to Assess the Potential for Pharmacodynamic Interaction of Centanafadine When Co-administered With Stimulants in Healthy Adults
Primary endpoint: Change from Baseline in Blood Pressure (BP) at Day 12 or Early Termination (ET)
Ecstasy to Alleviate SEvere Chronic Neuropathic Pain (EASE Pain) Trial: A Randomized Controlled Pilot Trial
Primary endpoint: The primary outcome of this pilot trial is to determine feasibility of a large-scale, multi-center trial.
Randomized Placebo-Controlled Trial of Methylphenidate for the Treatment of Post-Traumatic Stress Disorder With Associated Neurocognitive Complaints
Primary endpoint: PTSD Symptom Checklist for DSM-5 (PCL-5)
Orexin's Role in The Neurobiology of Substance Use Disorder
Primary endpoint: fMRI - cue reactivity
Evaluating Assessment and Medication Treatment of ADHD in Children With Down Syndrome
Primary endpoint: Mean magnitude of change in ADHD Symptoms as measured by parent and teacher report on the Vanderbilt ADHD Parent and Teacher Rating Scales, compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ]
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Primary endpoint: M/P ratio
Multimodal Therapy for the Treatment of Sleep Disturbance in Patients With Cancer
Primary endpoint: Pittsburgh Sleep Quality Index (PSQI) Score Change
Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy
Primary endpoint: Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores
FDA Decisions1 records
Frequently asked questions
Who is developing methylphenidate?
methylphenidate is being developed by AYTU BIOPHARMA, INC, Neos Therapeutics, Inc..
How many clinical trials involve methylphenidate?
BioSniper tracks 10 clinical trials involving methylphenidate.
What is methylphenidate's latest FDA decision?
The most recent tracked FDA decision for methylphenidate is Approval, dated June 19, 2017.