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Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

71 Participants Needed

TAK-861 for Narcolepsy

Recruiting at 56 trial locations

Overseen ByTakeda Contact

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Takeda

Disqualifiers: Epilepsy, Seizure, Schizophrenia, Bipolar, others

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial is testing TAK-861, a new drug, to help people with Narcolepsy Type 2 stay awake during the day. The study will measure how well the drug works by seeing if it helps participants stay awake longer. About 60 people will take part in this study, which will last several months.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What data supports the effectiveness of the drug TAK-861 for narcolepsy?

The research mentions that wake-promoting drugs, which increase dopamine release, are used to treat narcolepsy. Although TAK-861 is not directly mentioned, similar treatments like JZP-110, which also promotes wakefulness, have shown effectiveness in reducing sleepiness in narcolepsy patients.¹ ² ³ ⁴ ⁵

What makes the drug TAK-861 unique for treating narcolepsy?

TAK-861 is unique because it is designed to target the orexin 2 receptor, which plays a key role in regulating wakefulness, potentially offering a new approach to managing narcolepsy symptoms compared to traditional treatments that focus on symptom relief.⁵ ⁶ ⁷ ⁸ ⁹

Research Team

Medical Director

Principal Investigator

Takeda

Eligibility Criteria

Adults aged 18-70 with a diagnosis of Narcolepsy Type 2 (NT2) can join this trial. They must have had a sleep study in the last 5 years confirming NT2, or they may undergo another one if needed. People with other disorders causing excessive daytime sleepiness, certain psychiatric conditions, substance use disorders, or recent major surgery are not eligible.

Inclusion Criteria

I am between 18 and 70 years old.

I have been diagnosed with narcolepsy type 2 in the last 5 years.

Exclusion Criteria

I have a condition causing excessive daytime sleepiness, not including narcolepsy without cataplexy.

The participant has one or more of the following psychiatric disorders: Any current unstable psychiatric disorder, current or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), current diagnosis or history of substance use disorder as defined in the DSM-5. (Note: If the history of substance use disorder is more than 12 months before baseline, the participant may be allowed to enroll in the study after consultation with the sponsor or designee. (Participant must also have negative urine drug screen at the screening and Day -2 visit.), current active major depressive episode (MDE) or who have had an active MDE in the past 6 months.

I have had a stroke, mini-stroke, brain aneurysm, or blood vessel malformation in the last 5 years.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TAK-861 or placebo for 8 weeks to evaluate efficacy, safety, and tolerability

8 weeks

Regular visits for monitoring and questionnaire completion

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 weeks

Treatment Details

Interventions

Placebo
TAK-861

Trial OverviewThe trial is testing TAK-861 to see if it helps with narcolepsy symptoms like staying awake during the day. Participants will be randomly placed into three groups to receive either TAK-861 at two different doses or a placebo for eight weeks and complete questionnaires about their condition.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: TAK-861 2 milligrams (mg) BIDExperimental Treatment1 Intervention

Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.

Group II: TAK-861 2 mg and 5 mgExperimental Treatment1 Intervention

Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.

Group III: PlaceboPlacebo Group1 Intervention

Participants received placebo tablets matching TAK-861, orally, twice daily (BID), from Days 1 to 56.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Findings from Research

In a multicenter trial involving 285 patients with narcolepsy, sodium oxybate significantly improved quality of life, as measured by the Functional Outcomes of Sleep Questionnaire, compared to placebo.

The improvements were dose-related, with notable enhancements in various aspects of daily functioning, including activity level and social outcomes, indicating that sodium oxybate can effectively address symptoms of narcolepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial evaluating the effectiveness of sodium oxybate therapy on quality of life in narcolepsy.Weaver, TE., Cuellar, N.[2019]

In a study of 92 patients with narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia, significant improvements in patient-reported outcomes related to sleepiness and depression were observed after treatment, regardless of the specific diagnosis or treatment regimen used.

Higher standardized drug doses were associated with worsening depression scores, suggesting that careful consideration of drug burden is important in managing these patients' symptoms effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Pharmacotherapy Treatment on Patient-Reported Outcomes in a Narcolepsy and Idiopathic Hypersomnia Cohort.Pascoe, M., Bena, J., Foldvary-Schaefer, N.[2023]

In a phase 2b trial involving 93 adults with narcolepsy, JZP-110 significantly improved wakefulness and reduced excessive sleepiness compared to placebo, with notable increases in sleep latency and patient-reported outcomes over 12 weeks.

JZP-110 was well tolerated at doses of 150-300 mg/day, although some patients experienced side effects like insomnia and headache, leading to a 6.8% discontinuation rate due to adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Oral JZP-110 (ADX-N05) on Wakefulness and Sleepiness in Adults with Narcolepsy: A Phase 2b Study.Ruoff, C., Swick, TJ., Doekel, R., et al.[2019]