Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
Condition: Idiopathic Hypersomnia; Narcolepsy Without Cataplexy
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence; Cataplexy; Idiopathic Hypersomnia
Study type: Interventional
Phase: Phase 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. 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.
    

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, 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 overall severity, sleep inertia,
      cognitive dysfunction, and sleepiness, as well as other symptom questionnaires.

      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 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.
    

Intervention name(s): Modafinil; Amphetamine-Dextroamphetamine
Intervention type(s): Drug; Drug
Intervention description(s): Participants will received 100-400 milligrams (mg) per day of modafinil for 12 weeks.; Participants will receive 10-40 mg/day of oral amphetamine salts for 12 weeks.
Other intervention name(s): Provigil; Adderall
Intervention MeSH terms: Modafinil; Amphetamine; Adderall; Dextroamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment