Health TrialsbyHealthPanel

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

ConditionIdiopathic Hypersomnia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAlkermes, Inc.

About this trial

The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.

Meets the diagnostic criteria of Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG/MSLT/actigraphy) within the previous 10 years

Disqualifiers

Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle

Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject's ability to complete the study

Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1

Is currently pregnant, breastfeeding, or is planning to become pregnant during the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • ALKS 2680

    Drug

    Oral tablet containing ALKS 2680 for daily, oral administration

  • Placebo

    Drug

    Oral placebo tablet for daily administration

Treatment groups

126 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: ALKS 2680, 10 mg- Part AExperimental treatment 1 intervention
Group B: ALKS 2680, 14 mg -Part AExperimental treatment 1 intervention
Group C: ALKS 2680, 18 mg- Part AExperimental treatment 1 intervention
Group D: Placebo- Part APlacebo comparator 1 intervention
Group E: ALKS 2680 Dose 1- Part BExperimental treatment 1 intervention
Group F: Placebo - Part BPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level

Time frame
Up to 8 weeks

Secondary outcomes

1

Change in Idiopathic Hypersomnia Severity Scale (IHSS) from baseline to Week 8 by dose level

Time frame
Up to 8 weeks
2

Incidence of treatment emergent adverse events

Time frame
Up to 10 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alkermes, Inc.

Lead sponsor

Source ClinicalTrials.gov
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