Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2019 |
| Start Date: | April 2019 |
| End Date: | February 2022 |
| Contact: | Natalie Fernandez |
| Email: | natalie.fernandez@emory.edu |
| Phone: | 404-778-6114 |
Informing Treatment Decisions in the Central Disorders of Hypersomnolence: A Pragmatic Clinical Trial of Modafinil Versus Amphetamines
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.
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.
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.
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.
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
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