Health TrialsbyHealthPanel

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2

ConditionNarcolepsy Type 2
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, and disease symptoms in participants with Narcolepsy Type 2 (NT2) 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 the following: 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 NT2 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT).

Disqualifiers

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

Has a history or presence 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 2680-202 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, daily, orally, for 12 weeks

  • ALKS 2680 Dose 2

    Drug

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

  • ALKS 2680 Dose 3

    Drug

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

  • Placebo

    Drug

    Participants will receive placebo tablets, daily, orally for 12 weeks

Treatment groups

176 Participants
are divided into 4 treatment groups
Group A: ALKS 2680 Dose 1Experimental treatment 1 intervention
Group B: ALKS 2680 Dose 2Experimental treatment 1 intervention
Group C: ALKS 2680 Dose 3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 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

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
3

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

Time frame
Baseline to Week 12
4

Change in number of lapses on Psychomotor Vigilance Task (PVT) 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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