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Stimulant

Jornay PM for ADHD

Phase 4

Recruiting

Led By Lenard Adler, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with a current primary DSM-5 diagnosis of ADHD of predominantly inattentive presentation, or combined presentations as confirmed by the ACDS Version 1.2

Subjects who are not receiving any pharmacological treatment for ADHD must have a DSM AISRS 18 item total score of ≥ 28 at screening. Subjects who were previously receiving pharmacological treatment for ADHD at screening must have a minimum total DSM AISRS 18 item score of ≥ 22 at screening

Must not have

Concurrent treatment with a MAOI, or use of an MAOI within the preceding 14 days

Use of any prescribed benzodiazepine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 10 (24-hours post-dose)

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

"This trial aims to gather data on the effectiveness and tolerability of a sustained-release medication called JornayPM in adults with ADHD. JornayPM is unique because it is taken in the evening

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of Jornay PM may include insomnia, decreased appetite, weight loss, increased heart rate, mood swings, anxiety and possibly others as it has not been extensively studied in adults.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with ADHD, either inattentive or combined type.

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My ADHD score is above 28 without medication or above 22 with prior medication.

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently taking, nor have I taken an MAOI in the last 2 weeks.

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I am currently taking prescribed benzodiazepines.

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I do not have any unstable health conditions or significant heart or brain issues.

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I am on stable doses of antidepressants or anti-anxiety meds, but not on other psychotropic drugs.

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I did not respond to MPH treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 10 (24-hours post-dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 10 (24-hours post-dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 10 (24-hours post-dose) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 10

Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Score from Baseline to Week 3

Secondary study objectives

11-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 10

11-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 3

11-Hours Post-Dose Smoothness of Effect Scale (AMSES) Score at Visit 8

+46 more

Side effects data

From 2013 Phase 3 trial • 26 Patients • NCT01269463

31%

Insomnia

23%

Decreased Appetite

23%

Headache

19%

Irritability

15%

Cough

15%

Pyrexia

12%

Abdominal pain

12%

Nasal Congestion

12%

Rhinorrhoea

12%

Emesis

Influenza

Respiratory Tract Infection

Otitis Media

Sinusitis

Somnolence

Emotional Distress

Rash

Mood Swings

100%

80%

60%

40%

20%

Study treatment Arm

Methylphenidate HCl ER During Open Label Phase

Methylphenidate HCl ER Capsules During Double Blind Phase

Capsule Without Active Drug During Double Blind

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylphenidate Hydrochloride Extended Release Capsule

2011

Completed Phase 3

~30

0 / 8Eligibility criteria met