NCT06358950CompletedPhase 2
A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 1
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Alkermes, Inc.
- Enrollment
- 92
- Locations
- 47
- Primary Endpoint
- Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6
Study Overview
Brief Summary
The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-70 years of age
- •Has a BMI ≥18 and ≤40 kg/m2
- •Meets the diagnostic criteria of Narcolepsy type 1 according to ICSD-3-TR guidelines. Additionally, meets the following criteria:
- •Is HLA-DQB1*06:02-positive
- •Has residual excessive daytime sleepiness and cataplexy
- •Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study
- •Is willing to adhere to additional protocol requirements
Exclusion Criteria
- •Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator
- •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
Arms & Interventions
4 mg ALKS 2680
Experimental
Intervention: ALKS 2680 (Drug)
6 mg ALKS 2680
Experimental
Intervention: ALKS 2680 (Drug)
8 mg ALKS 2680
Experimental
Intervention: ALKS 2680 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6
Time Frame: Baseline to Week 6
Secondary Outcomes
- Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6(Baseline to Week 6)
- Mean weekly cataplexy rate (WCR) as derived by subject cataplexy diary(Measured at Week 5 and 6)
- Incidence of adverse events(Up to 15 Weeks)
Investigators
Study Sites (47)
Loading locations...
Similar Trials
Completed
Phase 2
Efficacy and Safety of Elpipodect (MK-8189) in Participants With an Acute Episode of Schizophrenia (MK-8189-008)SchizophreniaNCT04624243Merck Sharp & Dohme LLC499
Completed
Phase 1
Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel in Platinum-Resistant Non-Small Cell Lung CancerCarcinoma, Non-small-cell LungNCT00047801Telik28
Completed
Phase 1
A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine ALKS 4230 (Nemvaleukin Alfa) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Subjects With Select Advanced or Metastatic Solid Tumors (ARTISTRY-2)Advanced Solid TumorsNCT03861793Mural Oncology, Inc116
Completed
Phase 1
TLK286 (Telcyta) in Combination With Cisplatin for Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)Non-small Cell Lung CancerNCT00077883Telik50
Completed
Phase 1
Carboplatin, Paclitaxel and TLK286 (Telcyta) as First-Line Therapy in Advanced Non-Small Cell Lung CancerCarcinoma, Non-Small-Cell LungNCT00088556Telik100