Experimental: SDX for Idiopathic Hypersomnia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Idiopathic HypersomniaSerdexmethylphenidate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a study of the safety, efficacy and pharmacokinetics (PK) of Serdexmethylphenidate (SDX) compared to placebo in subjects with Idiopathic Hypersomnia (IH).

Eligible Conditions
  • Idiopathic Hypersomnia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 9 Secondary · Reporting Duration: Time Frame: Start of OLTP to end of DBWP (7 weeks)

Week 2
Change from baseline in Epworth Sleepiness Scale (ESS) score
Change from baseline in Modified Karolinska Sleepiness Scale in the morning and late afternoon.
Change from baseline in Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) total scores for depression, fatigue, and social functioning.
Change from baseline in Total Score of the Idiopathic Hypersomnia Severity Hypersomnia Scale (IHSS)
Change from baseline in the Patient-Reported Wakefulness Questionnaire (ZOGIM-A) total scores.
Change from baseline in the Sleep Inertia Visual Analog Scale (SIVAS) score.
Percentage of participants with increase (worsening) of 2 points or more baseline in the Patient Global Impression of Severity (PGI-S).
Percentage of participants with increase (worsening) of 2 points or more from baseline in the Clinical Global Impression of Severity (CGI-S)
Week 7
Safety parameter - Blood Pressure
Safety parameter - ECG
Safety parameter - Heart Rate
Safety parameter - Laboratory Tests
Safety parameter - PSQI
Safety parameters - TEAEs
Week 2
Change from baseline in Brain Fog score

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Experimental: SDX
1 of 2
Active Comparator
1 of 2

Experimental Treatment

Non-Treatment Group

48 Total Participants · 2 Treatment Groups

Primary Treatment: Experimental: SDX · Has Placebo Group · Phase 2

Experimental: SDX
Drug
Experimental Group · 1 Intervention: Serdexmethylphenidate · Intervention Types: Drug
Active ComparatorPlaceboComparator Group · 2 Interventions: Serdexmethylphenidate, Placebo · Intervention Types: Drug, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: time frame: start of oltp to end of dbwp (7 weeks)

Who is running the clinical trial?

Rho, Inc.Industry Sponsor
22 Previous Clinical Trials
5,388 Total Patients Enrolled
KemPharm, Inc.Lead Sponsor
2 Previous Clinical Trials
437 Total Patients Enrolled
Christopher Drake, PhDPrincipal InvestigatorInvestigator
2 Previous Clinical Trials
1,535 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be at least 18 years old in order to participate in the study.
Your Body Mass Index does not exceed 35 kg/m2.
You have a documented primary diagnosis of Insomnia Hyperarousal according to the International Classification of Sleep Disorders Third Edition criteria.
At the initial assessment and prior to OLTP, your Epworth Sleepiness Scale score must be 11 or higher.
You report and confirm a minimum of 7 hours of sleep per night.
You have satisfactory physical and neurological health, as confirmed by the Investigator through examinations, vital signs, ECGs, medical history and laboratory tests at Screening.
You have been utilizing a medically sanctioned form of contraception for two months prior to taking the initial dose of the study medication, are willing to continue employing such an approach throughout the duration of the research and for three months following your final dosage.
Participants must have been taking the same nicotine replacement therapy regimen and dose for at least two months prior to screening, and agree to maintain that dosage throughout the study.

Who else is applying?

What state do they live in?
New York100.0%
What site did they apply to?
Global Medical Institutes LLC- Princeton Medical Institute100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%