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

Description

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

Conditions

Narcolepsy Type 1, Narcolepsy Type 2

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Study Overview

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Study Details

Study overview

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

An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2

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

Condition
Narcolepsy Type 1
Intervention / Treatment

-

Contacts and Locations

Atlanta

Alkermes Investigational Site, Atlanta, Georgia, United States, 30328

Stockbridge

Alkermes Investigational Site, Stockbridge, Georgia, United States, 30281

Huntersville

Alkermes Investigational Site, Huntersville, North Carolina, United States, 28708

Cincinnati

Alkermes Investigational Site, Cincinnati, Ohio, United States, 45245

San Antonio

Alkermes Investigational Site, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alkermes, Inc.,

Medical Director, STUDY_DIRECTOR, Alkermes, Inc.

Study Record Dates

2027-11