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A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

ConditionsNarcolepsy Type 1Narcolepsy Type 2Idiopathic Hypersomnia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAlkermes, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3), ALKS 2680-302 (Brilliance NT1) , ALKS 2680-303 (Brilliance NT2) , ALKS 2680-304 (Brilliance NT 1)

Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects)

Disqualifiers

Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study

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

Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening

Trial design

Design model

Parallel

Treatments tested in this trial

  • ALKS 2680, 4mg

    Drug

    Oral tablet containing 4 mg of ALKS 2680 for once daily administration

  • ALKS 2680, 6mg

    Drug

    Oral tablet containing 6 mg of ALKS 2680 for once daily administration

  • ALKS 2680, 8mg

    Drug

    Oral tablet containing 8 mg of ALKS 2680 for once daily administration

  • ALKS 2680, 10mg

    Drug

    Oral tablet containing 10 mg of ALKS 2680 for once daily administration

  • ALKS 2680, 14mg

    Drug

    Oral tablet containing 14 mg of ALKS 2680 for once daily administration

  • ALKS 2680, 18mg

    Drug

    Oral tablet containing 18 mg of ALKS 2680 for once daily administration

Treatment groups

786 Participants
are divided into 3 treatment groups
Group A: Narcolepsy Type 1 (NT1)Experimental treatment 3 interventions
Group B: Narcolepsy Type 2 (NT2)Experimental treatment 3 interventions
Group C: Idiopathic Hypersomnia (IH)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events

Time frame
Up to 248 Weeks

Secondary outcomes

1

Change in the mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT)

Time frame
Baseline to Week 24
2

Change in Epworth Sleepiness Scale (ESS)

Time frame
Baseline to up to week 240
3

Change in weekly cataplexy rate (WCR)

Time frame
Baseline up to week 240
4

Change in Idiopathic Hypersomnia Severity Scale (IHSS)

Only applicable for IH participants

Time frame
Baseline up to week 240

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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