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

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. ^{1 2 3 4 5}

What makes the drug Jornay PM unique for treating ADHD?

Jornay PM is unique because it is an extended-release formulation of methylphenidate designed to be taken in the evening, allowing it to start working the next morning, which can help manage ADHD symptoms from the start of the day. ^{1 6 7 8 9}

Research Team

Lenard Adler, MD

Principal Investigator

NYU Langone Health

Eligibility 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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

A postmarketing clinical experience study of Metadate CD. [2019]

2. United States 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. [2021]

3. United States 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder. [2018]

5. Korea (South) 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. [2022]

6. United States 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. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Extended-release methylphenidate (Ritalin LA). [2018]

8. France pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Single-dose pharmacokinetics of NWP06, an extended-release methylphenidate suspension, in children and adolescents with ADHD. [2013]