Jornay PM for ADHD

Overseen By Terry Leon, MS, RN

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: NYU Langone Health

Must not be taking: MAOIs, Benzodiazepines, Antipsychotics, others

Disqualifiers: Bipolar, Psychotic disorders, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5-7 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well a new ADHD medication, Jornay PM, works for adults. Jornay PM is unique because it is taken in the evening and starts working by the next morning. The trial aims to gather information on adult responses to this medication, which is already approved for children. Adults with ADHD who aren't currently using ADHD drugs or haven't recently used stimulant medications might be a good fit. The trial will assess the medication's effectiveness and tolerability over several weeks. As a Phase 4 trial, this research helps determine how the already FDA-approved treatment benefits more patients.

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.

What is the safety track record for Jornay PM?

Research has shown that Jornay PM, a long-lasting form of methylphenidate, is generally safe and well-tolerated for individuals aged 6 and older with ADHD. Previous studies have found it effective in managing ADHD symptoms throughout the day. Although often prescribed for children, this study aims to collect safety information for adults.

Jornay PM is taken in the evening, unlike other ADHD medications. This timing helps control symptoms in the morning and throughout the day. Known risks include the potential for misuse or addiction, common with many stimulant medications.

While Jornay PM is approved for children, it is still under study for adults. This means limited information exists about its effects on adults, but its approval for children suggests a certain level of safety. Participants in this study will help gather the first detailed safety data for adult use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Jornay PM is unique because it is designed to be taken in the evening, unlike other ADHD medications that are typically taken in the morning. This delayed-release and extended-release formulation allows the medication to be active by the time the individual wakes up, potentially improving morning symptoms and reducing the need for a morning dose. Researchers are excited about Jornay PM because it could offer better symptom control throughout the day and minimize the impact of ADHD on daily routines right from the start of the day.

What is the effectiveness track record for Jornay PM in treating ADHD?

Research shows that Jornay PM, a long-acting form of methylphenidate, helps manage ADHD symptoms. Studies have found it significantly controls symptoms better than a placebo. Jornay PM is unique because it is taken at night and begins working the next morning, lasting throughout the day. It is approved for treating ADHD in individuals aged 6 and older. This trial will evaluate Jornay PM in adults, with participants receiving either a five-week or seven-week treatment period. Although clinical data for adults is not yet available, it has shown promise in improving focus and reducing impulsiveness and hyperactivity in younger patients. ^{2 3 4 5 6}

Who Is on the Research Team?

Lenard Adler, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Jornay PM

Trial Overview 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.

How Is the Trial Designed?

Group I: Five weeks of Jornay PM treatment Experimental Treatment 1 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 treatment Active Control 1 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)

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

In a study involving 308 patients aged 6-17 with ADHD, 65% showed significant improvement after 3 weeks of treatment with Metadate CD, indicating its effectiveness in real-world clinical practice.

The majority of patients (87%) reported satisfaction with Metadate CD, and those switching from other methylphenidate formulations found it to be as effective or better, with adverse events aligning with existing safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A postmarketing clinical experience study of Metadate CD. Dirksen, SJ., D'Imperio, JM., Birdsall, D., et al.[2019]

Methylphenidate effectively reduces symptoms of severe ADHD in about 75% of children when non-drug measures fail, with sustained-release formulations showing significant efficacy compared to placebo in clinical trials.

Sustained-release methylphenidate tablets and capsules are equally effective as short-acting versions but can pose risks such as gastrointestinal obstruction; therefore, starting treatment with short-acting methylphenidate is recommended before considering sustained-release options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained-release methylphenidate: new preparations. New pharmaceutical forms: a slight advantage for a small number of children. [2013]

The study involved 119 preschool children aged 4 to <6 years with ADHD, showing that the methylphenidate hydrochloride extended-release capsule (MPH-MLR) significantly reduced ADHD symptoms, with mean ADHD-RS-IV scores dropping from 40.8 to 19.5 during the open-label phase.

In a double-blind phase, children receiving MPH-MLR had a significantly greater improvement in ADHD symptoms compared to those on placebo, with common side effects including decreased appetite and insomnia, consistent with known effects of methylphenidate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Childress, AC., Kollins, SH., Foehl, HC., et al.[2021]

In a phase 3 study involving 90 children aged 6-12 with ADHD, methylphenidate hydrochloride extended-release chewable tablets (MPH ERCT) significantly reduced ADHD symptoms compared to placebo, with effects observed from 2 to 8 hours postdose.

The treatment was generally safe and well tolerated, with common side effects including decreased appetite and irritability, but no reports of suicidal ideation, indicating a favorable safety profile similar to other methylphenidate formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder. Wigal, SB., Childress, A., Berry, SA., et al.[2018]

In a study of 102 children with ADHD, switching from immediate-release methylphenidate (MPH-IR) to extended-release methylphenidate (OROS-MPH) showed significant improvements in behavior according to parents, particularly in controlling symptoms after school, without serious adverse effects.

While parents reported significant behavioral improvements with OROS-MPH, teachers did not observe the same level of improvement, indicating a discrepancy in perceived efficacy, but OROS-MPH did result in fewer tics compared to MPH-IR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Switching from Methylphenidate-Immediate Release (MPH-IR) to Methylphenidate-OROS (OROS-MPH): A Multi-center, Open-label Study in Korea. Kim, BN., Kim, YN., Cheong, US., et al.[2022]

PRC-063, an extended-release formulation of methylphenidate, provides higher evening and trough plasma levels compared to immediate-release methylphenidate, suggesting it may offer prolonged symptom relief for ADHD.

The pharmacokinetics of PRC-063 are not significantly affected by food intake, allowing for flexible administration, and it maintains a safety profile consistent with existing methylphenidate treatments, with no serious adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Crossover Trials of the Pharmacokinetics of PRC-063, a Novel Multilayer Extended-Release Formulation of Methylphenidate, in Healthy Adults. Katzman, MA., Mattingly, G., Klassen, LJ., et al.[2022]

PRC-063, an extended-release formulation of methylphenidate, significantly improved attention and reduced ADHD symptoms in children compared to placebo, with effects lasting up to 13 hours after dosing.

The treatment was well-tolerated, with adverse events similar to those seen with other methylphenidate treatments, including decreased appetite and insomnia, indicating a safety profile consistent with existing ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Childress, AC., Brams, MN., Cutler, AJ., et al.[2021]

Extended-release methylphenidate (Ritalin LA) effectively improves ADHD symptoms in children aged 6 to 12, showing significant improvement compared to placebo in a 2-week trial with 134 participants.

The pharmacokinetics of the extended-release formulation allow for once-daily dosing, mimicking the absorption profile of immediate-release methylphenidate, while maintaining a safety and tolerability profile similar to that of the immediate-release version.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended-release methylphenidate (Ritalin LA). Lyseng-Williamson, KA., Keating, GM.[2018]

The study evaluated the pharmacokinetics of an extended-release liquid formulation of methylphenidate (NWP06) in 14 pediatric subjects with ADHD, showing that the drug was well tolerated with no serious adverse events.

Results indicated that the pharmacokinetics of NWP06 were linear and dose proportional across different age groups (9-12 years and 13-15 years), suggesting consistent absorption and effectiveness for managing ADHD in children who cannot take solid formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-dose pharmacokinetics of NWP06, an extended-release methylphenidate suspension, in children and adolescents with ADHD. Childress, AC., Sallee, FR., Berry, SA.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06577779

Study Details | NCT06577779 | An Open-Label Treatment ... Participants found to have ≥30% change in their total Adult ADHD Investigator Symptom Rating Scale (AISRS) scores during the two-week observation ...

2. jornaypm-pro.com jornaypm-pro.com/

JORNAY PM (methylphenidate HCI) for ADHD Treatment JORNAY PM demonstrated statistically significant symptom control vs placebo in two Phase 3, randomized, double-blind, placebo-controlled studies.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7041320/

A Randomized, Double-Blind, Placebo-Controlled Study of ... Conclusion: DR/ER-MPH was well tolerated and demonstrated significant improvements versus placebo in functional impairment throughout the day across different ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/209311s010lbl.pdf

Jornay PM - accessdata.fda.gov Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and ...

5. jornaypm.com jornaypm.com/

Discover JORNAY PM® (methylphenidate HCI) for ADHD For ADHD in patients aged 6 years and older to increase attention and decrease impulsiveness and hyperactivity.

6. jornaypm.com jornaypm.com/safety

JORNAY PM® (methylphenidate HCI) Safety & Side Effects JORNAY PM is not recommended for use in children under 6 years of age with ADHD. JORNAY PM has a high risk of abuse, misuse, and addiction. Misuse and abuse of ...