Narcolepsy Type 1 Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific. The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this treatment period the participant will have the option to participate in a separate, long- term extension study during which all participants will be treated with TAK-861.
The drug being tested in this study is called TAK-861. This study will look at the effect of TAK-861 on improvement in narcolepsy symptoms, including excessive daytime sleepiness (EDS) and number of cataplexy episodes. The study will enroll approximately 100 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the five treatment groups which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): - TAK-861 Dose 1 - TAK-861 Dose 2 - TAK-861 Dose 3 - TAK-861 Dose 4 - Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 23 weeks. Participants will make multiple visits to the clinic during the treatment period and then will either enroll in a long-term extension study in which all participants will receive TAK-861 or have 2 final visits 7 and 28 days after last dose of study drug for follow-up assessments. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05983731 -
A Pilot Observational Study to Assess the Ability of Continuous 'Home' EEG to Accurately Diagnose Narcolepsy and Demonstrate Response to Treatment
|
||
Suspended |
NCT04419792 -
'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
|
||
Completed |
NCT05375890 -
Clinical and Neurophysiological Characteristics of Narcolepsy
|
||
Not yet recruiting |
NCT06292598 -
Bacterial Translocation and Gut Microbiota in Type 1 Narcolepsy Patients Versus a Control Population
|
||
Recruiting |
NCT06358950 -
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)
|
Phase 2 | |
Not yet recruiting |
NCT06457945 -
Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions
|
N/A | |
Not yet recruiting |
NCT06383806 -
Decreasing Nightmares in Adults With Narcolepsy
|
N/A | |
Not yet recruiting |
NCT05914194 -
A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1
|
Phase 3 | |
Recruiting |
NCT05967832 -
Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 Narcolepsy
|
N/A | |
Completed |
NCT05709873 -
Narcolepsy Nightmare Study
|
N/A | |
Recruiting |
NCT04483310 -
Meditation-Relaxation (MR Therapy) for Sleep Paralysis.
|
N/A | |
Completed |
NCT04445129 -
Wake and Sleep State Transitions on a Portable Electroencephalogram (EEG) Device in Narcolepsy Type 1 (NT1) and Healthy Participants
|
||
Completed |
NCT05460052 -
Evaluation of the Effectiveness of a Physical Activity Program on the Severity of Narcolepsy
|
||
Completed |
NCT05314556 -
Group Psychotherapy in Narcolepsy Type 1
|
N/A | |
Recruiting |
NCT05816382 -
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
|
Phase 2/Phase 3 | |
Recruiting |
NCT06336057 -
Mentalizating in Adults Suffering From Narcolepsy Type 1.
|
||
Recruiting |
NCT06251063 -
Improving Social Relationships for Adolescents With Central Disorders of Hypersomnolence
|
N/A | |
Completed |
NCT06241911 -
Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1
|
N/A |