Phase 2
N=44
Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
Idiopathic Hypersomnia · Narcolepsy Without Cataplexy
Bottom Line
View on ClinicalTrials.gov: NCT03772314 ↗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
| Outcome | Result | p-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
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.