BridgeMD
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
EU CTIS ID: 2024-519822-18-00
What this study is testing
To evaluate the safety and tolerability of ALKS 2680 in subjects with narcolepsy or IH
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Is willing and able to provide informed consent before study participation, as required by local regulations and IEC requirements.
- Was eligible for and has completed the EoT Visit of an ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible ALKS 2680 studies are ALKS 2680-201, ALKS 2680-202 and ALKS 2680-203.
- Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: a. Certain lifestyle considerations and restrictions detailed in the Section 5.3 b. Adherence to contraception guidance (examples include but are not limited to: IUD, hormonal contraception, and condom use, as applicable). For further details, please refer to Section 10.4.2. c. Adherence to study schedule, actigraphy wear requirements, and diary completion
- Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy or IH symptoms, including EDS and cataplexy, as applicable, for 5 half-lives prior to Day 1 (this discontinuation requirement is only applicable for re-entry subjects), and for the duration of study (for all subjects). See list of prohibited medications in Section 6.9.1. Subjects who roll over directly into the study from either ALKS 2680-201, ALKS 2680-202 or ALKS 2680-203 do not need to undergo medication discontinuation and will continue on ALKS 2680 uninterrupted.
- In the opinion of the investigator, the subject has experienced improvement in narcolepsy symptoms during the Open Label Extension Period of an ALKS 2680 eligible parent study in NT1 or NT2 (applies to subjects coming from Parent Study ALKS 2680-201 and Parent Study ALKS 2680-202, as applicable).
You likely can't join if
- Developed a new clinically significant health condition, ECG or laboratory abnormality, or finding in the eye and vision examination during the parent study or has an anticipated eye surgery during the course of the study that, in the opinion of the Investigator or Sponsor, may impact the subject’s participation in the study.
- Has a history or presence at Screening of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject’s ability to complete the study. This includes but is not necessarily limited to the following: a. Uncontrolled or unstable hypothyroidism or diabetes mellitus b. Clinically significant hepatic or renal disease c. Significant neurological disorder, including dementia, neurodegeneration, stroke, epilepsy, or seizures (excluding pediatric febrile seizures) d. Significant cardiovascular disease e. Major psychiatric or substance use disorder
- Is at a current risk of suicidal behavior; or has a “Yes” to questions 4 or 5 on the C-SSRS and/or had a suicide attempt in the period within 12 months prior to Screening.
- Has a positive alcohol breath test or urine drug screen for drugs of potential abuse at Screening. See Section 10.2 for details.
- If a re-entry subject, presence of the following laboratory abnormalities at Screening (one repeat is allowed at the Investigator’s discretion), including: a. Elevated liver function tests (ALT, AST) >1.5 times the upper limit of normal b. Positive serology test for HbsAg or hepatitis C antibody confirmed by RNA testing at Screening c. Renal creatinine clearance (Cockcroft-Gault Equation) ≤50 mL/min d. HbA1c ≥6.5%
- Is currently taking (or is anticipated to take) any prohibited prescription or OTC medications listed in Section 6.9.1, or will not be able to comply with provided washout requirements.
See the full eligibility criteria
Who can join
- Is willing and able to provide informed consent before study participation, as required by local regulations and IEC requirements.
- Was eligible for and has completed the EoT Visit of an ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible ALKS 2680 studies are ALKS 2680-201, ALKS 2680-202 and ALKS 2680-203.
- Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: a. Certain lifestyle considerations and restrictions detailed in the Section 5.3 b. Adherence to contraception guidance (examples include but are not limited to: IUD, hormonal contraception, and condom use, as applicable). For further details, please refer to Section 10.4.2. c. Adherence to study schedule, actigraphy wear requirements, and diary completion
- Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy or IH symptoms, including EDS and cataplexy, as applicable, for 5 half-lives prior to Day 1 (this discontinuation requirement is only applicable for re-entry subjects), and for the duration of study (for all subjects). See list of prohibited medications in Section 6.9.1. Subjects who roll over directly into the study from either ALKS 2680-201, ALKS 2680-202 or ALKS 2680-203 do not need to undergo medication discontinuation and will continue on ALKS 2680 uninterrupted.
- In the opinion of the investigator, the subject has experienced improvement in narcolepsy symptoms during the Open Label Extension Period of an ALKS 2680 eligible parent study in NT1 or NT2 (applies to subjects coming from Parent Study ALKS 2680-201 and Parent Study ALKS 2680-202, as applicable).
What rules you out
- Developed a new clinically significant health condition, ECG or laboratory abnormality, or finding in the eye and vision examination during the parent study or has an anticipated eye surgery during the course of the study that, in the opinion of the Investigator or Sponsor, may impact the subject’s participation in the study.
- Has a history or presence at Screening of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject’s ability to complete the study. This includes but is not necessarily limited to the following: a. Uncontrolled or unstable hypothyroidism or diabetes mellitus b. Clinically significant hepatic or renal disease c. Significant neurological disorder, including dementia, neurodegeneration, stroke, epilepsy, or seizures (excluding pediatric febrile seizures) d. Significant cardiovascular disease e. Major psychiatric or substance use disorder
- Is at a current risk of suicidal behavior; or has a “Yes” to questions 4 or 5 on the C-SSRS and/or had a suicide attempt in the period within 12 months prior to Screening.
- Has a positive alcohol breath test or urine drug screen for drugs of potential abuse at Screening. See Section 10.2 for details.
- If a re-entry subject, presence of the following laboratory abnormalities at Screening (one repeat is allowed at the Investigator’s discretion), including: a. Elevated liver function tests (ALT, AST) >1.5 times the upper limit of normal b. Positive serology test for HbsAg or hepatitis C antibody confirmed by RNA testing at Screening c. Renal creatinine clearance (Cockcroft-Gault Equation) ≤50 mL/min d. HbA1c ≥6.5%
- Is currently taking (or is anticipated to take) any prohibited prescription or OTC medications listed in Section 6.9.1, or will not be able to comply with provided washout requirements.
- Is currently pregnant, breastfeeding, or planning to become pregnant during the study.
- Is currently enrolled in another interventional clinical trial (other than the parent study) or used any investigational drug or interventional device within 30 days prior to Screening.
- Is employed by Alkermes, the CRO, or study site (permanent, temporary contract worker, or designee responsible for the conduct of the study) or is immediate family (ie, a spouse, parent, sibling, or child, whether biological or legally adopted) of an Alkermes, CRO, or study site employee.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.