The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
256
Oral tablet containing 4 mg of ALKS 2680 for once daily administration
Oral tablet containing 6 mg of ALKS 2680 for once daily administration
Oral tablet containing 8 mg of ALKS 2680 for once daily administration
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 100 Weeks
Change in the mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT)
Time frame: Baseline to Week 24
Change in Epworth Sleepiness Scale (ESS)
Time frame: Baseline to 96 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
Alkermes Investigator Site
Phoenix, Arizona, United States
RECRUITINGAlkermes Investigational Site
Little Rock, Arkansas, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Stanford, California, United States
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Colorado Springs, Colorado, United States
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Brandon, Florida, United States
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Miami, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
RECRUITING...and 34 more locations