ALKS 2680 for Narcolepsy

Recruiting at 10 trial locations

Overseen By Director, Global Clinical Services

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Alkermes, Inc.

Disqualifiers: Pregnancy, Breastfeeding, New health condition, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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) or Narcolepsy Type 2 (NT2) when taking ALKS 2680 tablets

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications prescribed for managing narcolepsy symptoms for a certain period before starting the trial and for the entire duration of the study.

What data supports the effectiveness of the drug ALKS 2680 for narcolepsy?

Sodium oxybate, a component similar to ALKS 2680, has been shown to improve symptoms like excessive daytime sleepiness and cataplexy in narcolepsy patients, suggesting potential effectiveness for ALKS 2680. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

Alkermes, Inc.

Eligibility Criteria

This trial is for people with Narcolepsy Type 1 or Type 2 who finished a previous ALKS 2680 study. They must be able to stop other narcolepsy meds safely and can't join if they're pregnant, breastfeeding, planning pregnancy, have new health issues, or are in another study.

Inclusion Criteria

Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1 or NT2. The current eligible studies are ALKS 2680-201 (Vibrance-1) and ALKS 2680-202 (Vibrance-2)

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)

Exclusion Criteria

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

I am not in another clinical study or haven't used experimental drugs or devices in the last 30 days.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ALKS 2680 tablets to measure safety, tolerability, and durability of treatment effect

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ALKS 2680 (Other)

Trial Overview The trial tests the long-term effects of different doses of ALKS 2680 tablets on safety and treatment durability for narcolepsy. Participants previously involved in specific ALKS studies will continue their treatment at varying dosages.

Participant Groups

Group I: Narcolepsy Type 2 (NT2) Experimental Treatment 3 Interventions

Group II: Narcolepsy Type 1 (NT1) Experimental Treatment 3 Interventions

Group III: Idiopathic Hypersomnia (IH) Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Alkermes, Inc.

Lead Sponsor

Trials

118

Recruited

27,200+

Richard Pops

Alkermes, Inc.

Chief Executive Officer since 1991

BA in Economics from Stanford University

Dr. Craig Hopkinson

Alkermes, Inc.

Chief Medical Officer since 2017

MD

Findings from Research

In a multicenter trial involving 285 patients with narcolepsy, sodium oxybate significantly improved quality of life, as measured by the Functional Outcomes of Sleep Questionnaire, compared to placebo.

The improvements were dose-related, with notable enhancements in various aspects of daily functioning, including activity level and social outcomes, indicating that sodium oxybate can effectively address symptoms of narcolepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial evaluating the effectiveness of sodium oxybate therapy on quality of life in narcolepsy. Weaver, TE., Cuellar, N.[2019]

In a study of 174 individuals with narcolepsy type 1, higher symptom severity was linked to lower health-related quality of life (HRQoL), affecting self-care, daily activities, and increasing feelings of pain and anxiety.

Key symptoms like excessive daytime sleepiness and disrupted nocturnal sleep were significant predictors of HRQoL, suggesting that managing these symptoms could enhance overall quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Symptom Severity on Health-Related Quality of Life in People with Narcolepsy Type 1. Li, C., Xie, L., Shang, S., et al.[2023]

Narcolepsy affects a small percentage of the population and is linked to genetic factors and the loss of hypocretin-producing neurons, suggesting an autoimmune component that may be triggered by environmental factors.

Current treatments like sodium oxybate and modafinil effectively manage symptoms such as excessive daytime sleepiness and cataplexy, while emerging therapies focus on both non-hypocretin-based and hypocretin-based approaches to improve outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in the management of narcolepsy. Abad, VC., Guilleminault, C.[2020]

In the phase 3 REST-ON trial involving 222 narcolepsy patients, the once-nightly formulation of sodium oxybate (ON-SXB) showed significant improvements in sleep latency, cataplexy attacks, and overall clinical improvement compared to placebo, with all results being statistically significant (p < 0.001).

The safety profile of ON-SXB was consistent with existing sodium oxybate treatments, with common side effects including nausea, vomiting, and dizziness, indicating that ON-SXB is a safe and effective option for managing narcolepsy symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy. Kushida, CA., Shapiro, CM., Roth, T., et al.[2023]

Narcolepsy type 1 is linked to hypocretin-1 deficiency and characterized by excessive daytime sleepiness and cataplexy, while narcolepsy type 2 has normal hypocretin-1 levels and no cataplexy, highlighting the different underlying mechanisms of these disorders.

Current treatments for narcolepsy focus on managing symptoms with medications like modafinil for daytime sleepiness and antidepressants for cataplexy, but ongoing monitoring of treatment efficacy is crucial, along with addressing associated symptoms and comorbid conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Options for Narcolepsy. Barateau, L., Lopez, R., Dauvilliers, Y.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized trial evaluating the effectiveness of sodium oxybate therapy on quality of life in narcolepsy. [2019]

2. England pubmed.ncbi.nlm.nih.gov

The Impact of Symptom Severity on Health-Related Quality of Life in People with Narcolepsy Type 1. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

New developments in the management of narcolepsy. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Treatment Options for Narcolepsy. [2018]