Expired Study
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Atlanta, Georgia 30329


Purpose:

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. 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.


Study summary:

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, for which randomized, controlled trial data show that other treatments are less beneficial than they are for participants with narcolepsy type 1. For the closely related disorder of idiopathic hypersomnia, clinical trial data to guide treatment decision-making are even more limited, with only three published controlled trials ever performed. To address these evidence gaps, the researchers propose a randomized, active-treatment controlled trial comparing modafinil and amphetamine salts for the treatment of narcolepsy type 2 and idiopathic hypersomnia. The primary outcome will be reduction in excessive daytime sleepiness, as measured by change in Epworth Sleepiness Scale scores from baseline to week 12 on treatment. Other important patient-reported outcomes will be considered as secondary outcomes, including Patient Global Impression of Change for sleep inertia, cognitive dysfunction, and sleepiness. In addition to directly comparing the efficacy of these two medications for hypersomnolent patients, this study will also evaluate for relatively safety in this population. Further, this study will assess clinical predictors of treatment response. All three of these aims will be complementary in informing shared decision-making about whether to treat with modafinil or amphetamine salts. Forty-four treatment-naïve adult patients seeking evaluation at the Emory Sleep Center for narcolepsy type 2 or idiopathic hypersomnia will be invited to participate and will be randomized to one of the treatment arms upon consent. Participants will receive study treatment for 12 weeks.


Criteria:

Inclusion Criteria: - A diagnosis of idiopathic hypersomnia or narcolepsy type 2 (without cataplexy), according with the International Classification of Sleep Disorders, third edition (ICSD-3) criteria Exclusion Criteria: - Obstructive sleep apnea (Apnea-Hypopnea Index (AHI) > 5) - Severe periodic limb movements of sleep with arousals (periodic limb movements (PLM) arousal index > 30) - Allergy to either of the study drugs - Contraindication to either of the study drugs - For modafinil, these contraindications include: history of left ventricular hypertrophy, mitral valve prolapse, severe cardiovascular disease, unstable angina, myocardial infarction, severe hepatic impairment, substance abuse history, psychosis, or unstable depression or mania - Contraindications to amphetamine salts, in addition to those listed above, include: other cardiac structural abnormalities, cardiomyopathy, severe arrhythmias, uncontrolled hypertension, glaucoma, Tourette's syndrome, and epilepsy - Women who are pregnant, planning to become pregnant within 16 weeks, or breastfeeding will be excluded


NCT ID:

NCT03772314


Primary Contact:

Principal Investigator
Lynn Marie Trotti, MD, MSc
Emory University

Natalie Fernandez
Phone: 404-778-6114
Email: natalie.fernandez@emory.edu


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30329
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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