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Phase 2 N=44 Randomized Quadruple-blind Treatment

Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia

Idiopathic Hypersomnia · Narcolepsy Without Cataplexy

Enrolled (actual)
44
Serious AEs
2.3%
Results posted
May 2024
Primary outcome: Primary: Change in Epworth Sleepiness Scale (ESS) Score — 5.0; 4.4 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Modafinil (Drug); Amphetamine-Dextroamphetamine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Emory University
Primary completion
May 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Epworth Sleepiness Scale (ESS) Score
5.0; 4.4
SECONDARY
Number of Participants Reporting Any Improvement by Patient Global Impression of Change (PGIC) for Overall Disease Severity Score
18; 16
SECONDARY
Number of Participants Reporting Much or Very Much Improvement by Patient Global Impression of Change (PGIC) for Overall Disease Severity Score
13; 10
SECONDARY
Number of Participants Reporting Any Improvement From Baseline on Patient Global Impression of Change (PGIC) for Sleepiness Score
19; 16
SECONDARY
Number of Participants Reporting Much or Very Much Improvement From Baseline on Patient Global Impression of Change (PGIC) for Sleepiness Score
14; 10
SECONDARY
Number of Participants Reporting Any Improvement With Patient Global Impression of Change (PGIC) for Cognitive Dysfunction Score
16; 13
SECONDARY
Number of Participants Reporting Much or Very Much Improvement With Patient Global Impression of Change (PGIC) for Cognitive Dysfunction Score
5; 10
SECONDARY
Number of Participants Reporting Any Improvement by Patient Global Impression of Change (PGIC) for Sleep Inertia Score
11; 11
SECONDARY
Number of Participants Reporting Much or Very Much Improvement by Patient Global Impression of Change (PGIC) for Sleep Inertia Score
4; 4
SECONDARY
Change in Hypersomnia Severity Index (HSI) From Baseline
8.0; 10.4
SECONDARY
Change in Sleep Inertia Questionnaire (SIQ) Score From Baseline
19.0; 18.2

Summary

For diseases that cause excessive daytime sleepiness (such as narcolepsy and idiopathic hypersomnia), there are several medications that can be used to treat sleepiness. However, it can be difficult to decide which medication to use for a particular individual for several reasons: 1) there are very few studies that directly compare two medications to see which works best; 2) there are very few studies that include people with a disorder of sleepiness called idiopathic hypersomnia. To address this gap in knowledge, the researchers propose a randomized clinical trial comparing modafinil and amphetamine salts in patients with narcolepsy type 2 or idiopathic hypersomnia. All participants will either receive modafinil or amphetamine salts - no participant will receive placebo. This study will evaluate which medication works better to improve sleepiness. The researchers will also see which medication is better for other symptoms including difficulty waking up and difficulty thinking, as well as seeing which medication causes fewer side effects. Finally, this study will see if any information about patients (such as age or sleep study features) predicts responding better to one medication or the other.

Eligibility Criteria

Inclusion Criteria

  • narcolepsy type 2 or idiopathic hypersomnia
  • ability to give informed consent

Exclusion Criteria

  • contraindication to modafinil or amphetamine salts (history of left ventricular hypertrophy, mitral valve prolapse, other cardiac structural abnormalities, severe cardiovascular disease, unstable angina, myocardial infarction, cardiomyopathy, severe arrhythmias, uncontrolled hypertension, severe hepatic impairment, substance abuse history, psychosis, glaucoma, Tourette's syndrome, and epilepsy)
  • obstructive sleep apnea (Apnea-Hypopnea Index (AHI) > 15)
  • severe periodic limb movements of sleep with arousals (periodic limb movements (PLM) arousal index > 30)
  • allergy to either of the study drugs
  • pregnancy or breastfeeding
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03772314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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