Status:
COMPLETED
Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
Lead Sponsor:
Emory University
Collaborating Sponsors:
American Academy of Sleep Medicine
Conditions:
Idiopathic Hypersomnia
Narcolepsy Without Cataplexy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 t...
Detailed Description
Currently, there are insufficient data to guide clinical practice regarding the use of amphetamines for the treatment of narcolepsy. This may be particularly important in the case of narcolepsy type 2...
Eligibility Criteria
Inclusion
- narcolepsy type 2 or idiopathic hypersomnia
- ability to give informed consent
Exclusion
- 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
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03772314
Start Date
April 15 2019
End Date
May 4 2023
Last Update
May 23 2024
Active Locations (1)
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1
Emory Sleep Center
Atlanta, Georgia, United States, 30329