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A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

ConditionNarcolepsy Type 1
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAlkermes, Inc.

About this trial

The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT* or CSF hypocretin-1 level).

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 participant safety, interfere with any study assessment, or affect the participant's ability to complete the study.

Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment.

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 Dose 1

    Drug

    Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks

  • ALKS 2680 Dose 2

    Drug

    Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks

  • Placebo

    Drug

    Participants will receive ALKS 2680-matching placebo tablets, orally, for 12 weeks.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: ALKS 2680 Dose 1Experimental treatment 1 intervention
Group C: ALKS 2680 Dose 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level

Time frame
Baseline to Week 12

Secondary outcomes

1

Change in Epworth Sleepiness Scale (ESS) from baseline to Week 12 by dose level

Time frame
Baseline to Week 12
2

Weekly cataplexy rate (WCR) at Week 12 by dose level

Time frame
Week 12
3

Percentage of participants who achieve a status of "none" or "mild" on Patient Global Impression- Severity (PGI-S) scale (general disease) at Week 12 by dose level

Time frame
Week 12
4

Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline to Week 12 by dose level

Time frame
Baseline to Week 12

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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