TAK-861 Dose 2 for Narcolepsy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Delta Waves LLC - Hunt - PPDS, Colorado Springs, CONarcolepsyTAK-861 - Drug
Eligibility
16 - 70
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Narcolepsy Type 1

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Baseline up to approximately 16 weeks

Week 16
Occurrence of at Least One Related Treatment-emergent Adverse Event (TEAE)
Baseline, Week 8
Change from Baseline to Week 8 in Epworth Sleepiness Scale (ESS) Total Score
Change from Baseline to Week 8 in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)
Week 8
Weekly Cataplexy Rate at Week 8

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

5 Treatment Groups

TAK-861 Dose 2
1 of 5
TAK-861 Dose 1
1 of 5
TAK-861 Dose 3
1 of 5
TAK-861 Dose 4
1 of 5
Placebo
1 of 5

Experimental Treatment

Non-Treatment Group

100 Total Participants · 5 Treatment Groups

Primary Treatment: TAK-861 Dose 2 · Has Placebo Group · Phase 2

TAK-861 Dose 2
Drug
Experimental Group · 1 Intervention: TAK-861 · Intervention Types: Drug
TAK-861 Dose 1
Drug
Experimental Group · 1 Intervention: TAK-861 · Intervention Types: Drug
TAK-861 Dose 3
Drug
Experimental Group · 1 Intervention: TAK-861 · Intervention Types: Drug
TAK-861 Dose 4
Drug
Experimental Group · 1 Intervention: TAK-861 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to approximately 16 weeks

Who is running the clinical trial?

TakedaLead Sponsor
1,135 Previous Clinical Trials
4,063,396 Total Patients Enrolled
7 Trials studying Narcolepsy
717 Patients Enrolled for Narcolepsy
Study DirectorStudy DirectorTakeda
1,089 Previous Clinical Trials
483,444 Total Patients Enrolled
4 Trials studying Narcolepsy
358 Patients Enrolled for Narcolepsy

Eligibility Criteria

Age 16 - 70 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your weight is within a healthy range for your height, with a BMI between 18 and 40 kg/m^2.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.