{"id":"open-label-pr-oros-methylphenidate","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Nausea"},{"rate":"10-20%","effect":"Headache"},{"rate":"5-10%","effect":"Insomnia"},{"rate":"5-10%","effect":"Anxiety"},{"rate":"5-10%","effect":"Dizziness"}]},"_chembl":{"chemblId":"CHEMBL796","moleculeType":"Small molecule","molecularWeight":"233.31"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Methylphenidate is a dopamine-norepinephrine reuptake inhibitor, which means it blocks the reabsorption of these neurotransmitters, allowing them to stay in the synaptic cleft for longer periods and increasing their availability for binding to postsynaptic receptors. This leads to increased alertness, attention, and energy levels.","oneSentence":"Methylphenidate is a central nervous system stimulant that works by increasing the levels of dopamine and norepinephrine in the brain.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:24:30.272Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Attention deficit hyperactivity disorder (ADHD)"}]},"trialDetails":[{"nctId":"NCT00307684","phase":"PHASE3","title":"Open Label, Multicentre Extension Study of Protocol 42603ATT3002 to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)","status":"COMPLETED","sponsor":"Janssen-Cilag International NV","startDate":"2006-01","conditions":"Attention Deficit Disorder With Hyperactivity","enrollment":155},{"nctId":"NCT00482313","phase":"PHASE3","title":"Efficacy and Effectiveness of Methylphenidate in Swedish Male Prison Inmates With Attention-deficit Hyperactivity Disorder (ADHD)","status":"COMPLETED","sponsor":"Psychiatry Karolinska","startDate":"2007-05","conditions":"Attention Deficit Hyperactivity Disorder","enrollment":30}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"open label PR OROS methylphenidate","genericName":"open label PR OROS methylphenidate","companyName":"Janssen-Cilag International NV","companyId":"janssen-cilag-international-nv","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Open label PR OROS methylphenidate is used to treat Attention Deficit Hyperactivity Disorder and Attention Deficit Disorder With Hyperactivity. It works by inhibiting the sodium-dependent dopamine transporter, a mechanism that affects dopamine levels in the brain.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}