Jornay PM for ADHD
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: NYU Langone Health
Must not be taking: MAOIs, Benzodiazepines, Antipsychotics, others
Disqualifiers: Bipolar, Psychotic disorders, Autism, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The goal of this study is to extend the efficacy evidence of sustained release methylphenidate compound (JornayPM) in adults with Attention-deficit/hyperactivity disorder (ADHD). JornayPM has recently been approved for treatment of patients 6 years and older with ADHD; the release mechanism is unique among ADHD products in that it is taken in the evening, with effects in the morning upon awakening and then throughout the subsequent day. Of note, to date, there is no clinical data as to the tolerability or clinical effects or dosing in adults with ADHD; therefore the primary aim of this trial is to gather the first set of these data.
Do I have to stop taking my current medications for the trial?
You may need to stop certain medications, but if you're on stable doses of antidepressants or anti-anxiety medications, you can continue them. Other psychotropic medications like mood stabilizers and antipsychotics are not allowed.
Is Jornay PM safe for humans?
Jornay PM, which contains methylphenidate, has been studied for safety in children with ADHD. Common side effects include decreased appetite, weight loss, trouble sleeping, high blood pressure, and mood changes, which are consistent with known effects of methylphenidate.
12345Eligibility Criteria
This trial is for adults with ADHD who have not yet tried Jornay PM, a medication taken in the evening to help manage symptoms throughout the next day. Participants must be diagnosed with ADHD and fit specific health criteria that will be detailed by the study.Inclusion Criteria
Able to provide signed informed consent
I have been diagnosed with ADHD, either inattentive or combined type.
I haven't taken any stimulant medications in the last 2 months.
+5 more
Exclusion Criteria
Any history of severe past drug dependence determined by the MINI
Active suicidality within past year, or history of suicide attempt in past 2 years
I am not currently taking, nor have I taken an MAOI in the last 2 weeks.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Observation Stabilization
Participants undergo a two-week observation stabilization period to assess changes in ADHD symptoms
2 weeks
Treatment
Participants receive open-label treatment with Jornay PM for either 5 or 7 weeks depending on the arm group
5-7 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 weeks
Participant Groups
The study tests Jornay PM's effectiveness on adult ADHD symptoms, focusing on executive function and emotional regulation from morning until early evening. It's an open-label trial where everyone knows they're taking Jornay PM but are observed at random.
2Treatment groups
Experimental Treatment
Active Control
Group I: Five weeks of Jornay PM treatmentExperimental Treatment1 Intervention
Enrolled participants will begin with a two-week observation stabilization before starting treatment with Jornay PM. Participants found to have ≥30% change in their total Adult ADHD Investigator Symptom Rating Scale (AISRS) scores during the two-week observation stabilization period treatment will be discontinued from the study. Remaining participants will initiate a 5 week open-label treatment with Jornay PM followed by a two week observation period; not receiving Jornay PM.
Group II: Seven weeks of Jornay PM treatmentActive Control1 Intervention
Enrolled participants will begin with a two-week observation stabilization before starting treatment with Jornay PM. Participants found to have ≥30% change in their total Adult ADHD Investigator Symptom Rating Scale (AISRS) scores during the two-week observation stabilization period treatment will be discontinued from the study. Remaining participants will initiate a 7 week open-label treatment with Jornay PM.
Jornay PM is already approved in United States for the following indications:
🇺🇸 Approved in United States as Jornay PM for:
- Attention Deficit Hyperactivity Disorder (ADHD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NYU Langone HealthNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor
References
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 Multilayer, Extended-Release Methylphenidate (PRC-063) in Children 6-12 Years of Age with Attention-Deficit/Hyperactivity Disorder: A Laboratory Classroom Study. [2021]Objective: To determine the safety and efficacy of PRC-063, a once-daily, multilayer, extended-release (ER) formulation of methylphenidate (MPH) hydrochloride, in the treatment of attention-deficit/hyperactivity disorder (ADHD) in children in a randomized, double-blind, parallel group, dose-optimized, placebo-controlled phase 3 study. Methods: Boys and girls aged 6-12 years diagnosed with ADHD were enrolled. During a 6-week, open-label, dose-optimization phase, subjects began treatment at 25 mg/day of PRC-063 and were titrated until an optimal dose (maximum 85 mg/day) was reached. During the double-blind period, subjects were randomized to receive treatment with their optimal dose of PRC-063 or placebo for 1 week. Efficacy was assessed in a laboratory classroom setting on the final day of the double-blind treatment using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale and Permanent Product Measure of Performance (PERMP). Safety was assessed measuring adverse events (AEs), vital signs, and electrocardiograms. Results: The study was completed by 147 subjects. In the primary efficacy analysis, significant improvements were demonstrated with PRC-063 versus placebo (p < 0.0001) when SKAMP-Combined scores were averaged over the 13-hour full-day laboratory classroom (least squares mean difference = -8.6, 95% confidence interval = -10.6 to -6.6). Mean average PERMP-Total scores were also significantly improved with PRC-063 versus placebo at all time points postdose (p < 0.01). The onset of treatment effect was present by 1-hour postdose (the first time point measured) and duration of efficacy was up to and including 13 hours postdose. AEs reported in ≥5% of subjects during the dosing optimization period were decreased appetite, abdominal pain upper, affect lability, weight decreased, headache, irritability, and insomnia. Conclusions: PRC-063 was effective in improving attention and reducing symptoms of ADHD versus placebo and had a rapid onset and extended duration of effect. AEs were consistent to those reported with other ER MPH treatments. Clinical Trial Registry: NCT03172481.
Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Titration Study of Methylphenidate Hydrochloride Extended-Release Capsules (Aptensio XR) in Preschool Children with Attention-Deficit/Hyperactivity Disorder. [2021]Objectives: To assess the efficacy and safety of a methylphenidate hydrochloride extended-release capsule (MPH-MLR) formulation in treating attention-deficit/hyperactivity disorder (ADHD) in preschool children. Methods: Children aged 4 to <6 years with qualifying ADHD Rating Scale Fourth Edition (ADHD-RS-IV) Preschool Version scores (≥90th percentile for age/gender) participated in four behavior management training (BMT) sessions or immediately entered (based on investigator assessment of symptom severity or previous participation) into a 6-week, open-label, flexible MPH-MLR dose optimization phase. After BMT, children with <30% improvement in ADHD-RS-IV score and ≥3 score on the Clinical Global Impression-Improvement (CGI-I) scale also entered the open-label period. All children began the open-label period with MPH-MLR 10 mg once daily; weekly adjustments permitted once-daily maximum of up to 40 mg. Children with ≥30% improvement in ADHD-RS-IV total score and a CGI-I score of 1-2 at open-label completion were randomized to their optimized dose of MPH-MLR or placebo for 2 weeks (double blind [DB]). Safety measures included adverse events (AEs), vital signs, and electrocardiograms. Results: Open-label enrollment was 119 children. Mean (SD) ADHD-RS-IV total scores at open-label start and open-label end was 40.8 (10.4) and 19.5 (11.1), respectively. Ninety children were enrolled in the DB phase. Mean (SD) ADHD-RS-IV total scores for the MPH-MLR and placebo group were similar at DB beginning and was 25.8 (14.6) and 34.9 (14.1), respectively, at DB end. Mean change from baseline in ADHD-RS-IV total score during DB was significantly greater in children randomized to placebo compared with MPH-MLR; least squares mean change difference from baseline was -11.2, p = 0.002. During open-label dosing, the most common AEs (≥10%) were decreased appetite, decreased weight, insomnia, hypertension, emotional disorder, and affect lability. Conclusion: Results demonstrate MPH-MLR efficacy in preschool children and a safety profile consistent with known AEs of methylphenidate when used for ADHD.
Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder. [2018]This phase 3, laboratory classroom study assessed the efficacy and safety of methylphenidate hydrochloride extended-release chewable tablets (MPH ERCT) compared with placebo in children with attention-deficit/hyperactivity disorder (ADHD).
Switching from Methylphenidate-Immediate Release (MPH-IR) to Methylphenidate-OROS (OROS-MPH): A Multi-center, Open-label Study in Korea. [2022]The objective of this study was to evaluate the efficacy and safety of methylphenidate HCL OROS extended-release (OROS-MPH) among children with attention deficit hyperactivity disorder (ADHD) who had been previously treated with methylphenidate HCL immediate-release (MPH-IR).
Randomized Controlled Crossover Trials of the Pharmacokinetics of PRC-063, a Novel Multilayer Extended-Release Formulation of Methylphenidate, in Healthy Adults. [2022]PRC-063 is a once-daily, extended-release oral formulation of methylphenidate hydrochloride developed to provide early and prolonged symptom improvement in patients with attention-deficit/hyperactivity disorder.
Extended-release methylphenidate (Ritalin LA). [2018]An extended-release formulation of methylphenidate (Ritalin LA), a CNS stimulant that inhibits dopamine and noradrenaline (norepinephrine) reuptake into presynaptic neurons, has been developed for use in patients with attention deficit/hyperactivity disorder (ADHD). In children with ADHD and healthy male adults, extended-release methylphenidate 20mg was rapidly absorbed and demonstrated two distinct peak plasma concentrations approximately 4 hours apart. The absorption pharmacokinetics of extended-release methylphenidate 20mg, which closely mimics those of immediate-release methylphenidate 10mg given in two doses 4 hours apart, permits once-daily administration. In a 2-week randomised, double-blind, placebo-controlled trial in 134 evaluable children aged 6 to 12 years with ADHD, symptoms improved to a significantly greater extent with extended-release methylphenidate 10 to 40mg once daily than with placebo. Extended-release methylphenidate improved both inattention and hyperactivity symptoms and was effective in children with combined- (inattentive and hyperactive/impulsive) type or predominantly inattentive-type ADHD. In clinical trials, the safety and tolerability profiles of extended-release methylphenidate were consistent with that of the immediate-release formulation.
Sustained-release methylphenidate: new preparations. New pharmaceutical forms: a slight advantage for a small number of children. [2013](1) When non-drug measures don't work in severe attention-deficit/hyperactivity disorder, methylphenidate, an amphetamine, attenuates symptoms in about 75% of children, at least in the short term. (2) Two forms of sustained-release methylphenidate--tablets (Concerta LP) and microgranule-filled capsules (Ritaline LP)--are marketed in France. (3) In two cross-over trials (one week per treatment) and in a parallel-group trial lasting one month, sustained-release methylphenidate tablets (18 mg to 54 mg/day in a single dose) were no more or less effective than short-acting methylphenidate (5 mg to 15 mg three times a day), but the sustained-release formulation was significantly more effective than placebo. The rating scale used in these trials was not sensitive enough to show whether the two forms had the same duration of action. A one-year non comparative trial in 435 children suggested that initial efficacy persisted in at least half the children treated with sustained-release tablets. (4) The only clinical trial of sustained-release methylphenidate capsules--a randomised double-blind placebo controlled trial lasting two weeks--showed that sustained-release capsules were more effective than placebo. (5) All these short-term trials confirmed the known amphetamine-like adverse effects of methylphenidate. The sustained-release tablets are large and rigid. They have the potential to cause gastrointestinal obstruction. (6) The sustained-release tablets can be difficult to swallow, and must not be cut, crushed, or chewed. The capsules can be opened so the microgranules inside them can be mixed with food. (7) In practice, it is best to start with short-acting methylphenidate, which is better evaluated than sustained-release formulations. If it's effective, and if treatment needs to be simplified, the child can be switched to a sustained-release form later; capsules are less risky than tablets, and are also more convenient.
Single-dose pharmacokinetics of NWP06, an extended-release methylphenidate suspension, in children and adolescents with ADHD. [2013]Extended-release formulations of stimulants provide once-daily treatment options for patients with attention-deficit/hyperactivity disorder (ADHD). Such preparations are more convenient and may improve compliance, and thus, improve outcomes. Currently, there is no extended-release liquid oral preparation of any stimulant. As such, there is a medical need for a liquid extended-release preparation of methylphenidate for the management of ADHD in children who are unable or unwilling to swallow solid formulations.