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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 16 weeks
Awards & highlights
Study Summary
This trial will test a new drug (TAK-861) to see if it can help reduce symptoms of narcolepsy. 100 people worldwide will take part in the trial.
Who is the study for?
Adults aged 18-70 with narcolepsy type 1 confirmed by sleep tests, a BMI of 18-40 kg/m^2, and specific genetic markers or low levels of the brain hormone orexin. Excluded are those with significant medical conditions like heart disease, liver or thyroid issues, history of cancer within five years (except certain skin cancers), head trauma, seizures, stroke risks, infectious diseases like hepatitis B/C or HIV, poor kidney function or high liver enzyme levels.Check my eligibility
What is being tested?
The study is testing TAK-861 to see if it improves daytime sleepiness and cataplexy in people with narcolepsy. Participants will randomly receive either TAK-861 or a placebo for up to 12 weeks across various regions globally. Afterward, they may join an extension study where everyone gets TAK-861.See study design
What are the potential side effects?
While the trial doesn't explicitly list side effects for TAK-861 since it's under investigation, common side effects for narcolepsy medications can include headache, nausea, dizziness and irritability. The exact side effects will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to approximately 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline to Week 8 in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)
Secondary outcome measures
Change from Baseline to Week 8 in Epworth Sleepiness Scale (ESS) Total Score
Occurrence of at Least One Related Treatment-emergent Adverse Event (TEAE)
Weekly Cataplexy Rate at Week 8
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: TAK-861 Dose 4Experimental Treatment1 Intervention
Participants will receive TAK-861 dose 4, orally, from Day 1 up to Weeks 8 or 12.
Group II: TAK-861 Dose 3Experimental Treatment1 Intervention
Participants will receive TAK-861 dose 3, orally, from Day 1 up to Weeks 8 or 12.
Group III: TAK-861 Dose 2Experimental Treatment1 Intervention
Participants will receive TAK-861 dose 2, orally, from Day 1 up to Weeks 8 or 12.
Group IV: TAK-861 Dose 1Experimental Treatment1 Intervention
Participants will receive TAK-861 dose 1, orally, from Day 1 up to Weeks 8 or 12.
Group V: PlaceboPlacebo Group1 Intervention
Participants will receive TAK-861 matching placebo tablets, orally, from Day 1 up to Weeks 8 or 12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-861
2023
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,150 Total Patients Enrolled
8 Trials studying Narcolepsy
877 Patients Enrolled for Narcolepsy
Study DirectorStudy DirectorTakeda
1,207 Previous Clinical Trials
489,568 Total Patients Enrolled
5 Trials studying Narcolepsy
518 Patients Enrolled for Narcolepsy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a significant heart condition such as heart disease, heart attack history, severe chest pain, abnormal heart rhythm, or heart failure.You have a medical condition other than narcolepsy with cataplexy that causes excessive daytime sleepiness.You had cancer in the past 5 years, except for certain types like early-stage skin cancers.You have tested positive for hepatitis B, hepatitis C, or HIV.Your kidneys are not working well, and your creatinine clearance is less than 50 mL/minute.Your liver enzymes (ALT or AST) are more than 1.5 times the normal level.Your body mass index (BMI) is between 18 and 40.You have been diagnosed with narcolepsy type 1 within the last 10 years using specific sleep tests.You have a specific genetic marker or low levels of a substance in your spinal fluid related to a sleep disorder.You or someone in your family has a history of seizures, except for one seizure caused by a fever when you were a child.You have certain mental health conditions, including unstable psychiatric disorder, history of manic or hypomanic episodes, schizophrenia, major depression with psychotic features, substance use disorder, or have been recently depressed.
Research Study Groups:
This trial has the following groups:- Group 1: TAK-861 Dose 1
- Group 2: TAK-861 Dose 2
- Group 3: TAK-861 Dose 3
- Group 4: TAK-861 Dose 4
- Group 5: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the age cutoff for enrollment in this trial extend to younger than 30 years old?
"This medical study is open to individuals aged 16-70. Separate clinical trials are available for those under 18 and above 65 years old, comprising 8 and 9 respectively."
Answered by AI
Has the FDA sanctioned TAK-861 Dose 2?
"While there is some proof of safety, no evidence of efficacy exists for TAK-861 Dose 2. Therefore, on our scale from 1 to 3 it receives a score of two."
Answered by AI
How many participants are currently participating in this medical experiment?
"For this project to succeed, a pool of 100 qualified participants must be recruited. Potential volunteers can join from either SDS Clinical Trials in Santa Ana or Delta Waves LLC - Hunt - PPDS in Colorado Springs."
Answered by AI
Is this research project currently recruiting new participants?
"Affirmative, the information on clinicaltrials.gov reveals that this research is in need of participants. It was initially posted January 9th 2023 and most recently modified on January 31st 2023. The study requires 100 individuals to be enrolled at 7 individual sites."
Answered by AI
In which healthcare facilities is this study being conducted?
"The experiment is presently running across 7 different sites, including Santa Ana, Colorado Springs and Orlando. It's advised that a participant choose the closest location to them in order to reduce travelling requirements."
Answered by AI
Is enrollment for this medical trial open to me?
"This clinical trial will be recruiting 100 individuals aged 16 to 70, suffering from narcolepsy type 1. Applicants must have a BMI of 18-40 kg/m^2 and the HLA genotype HLA-DQB1*06:02 or CSF orexin concentration <110 pg/mL."
Answered by AI
Who else is applying?
What site did they apply to?
Comprehensive Sleep Medicine Associates - Sugar Land
What portion of applicants met pre-screening criteria?
Met criteria
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