A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions

Narcolepsy Type 1 Clinical Trial

Official title:

A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816382
• Other study ID #: TAK-861-2003
• Secondary ID: 2022-002965-13U1
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 5, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim is to evaluate the safety and tolerability of TAK-861 on participants with type 1 and type 2 narcolepsy from previous parent studies, TAK-861-2001 (NCT05687903) and TAK-861-2002 (NCT05687916).

Description:

The drug being tested in this study is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). This study will look at the safety of TAK-861 along with improvement in narcolepsy symptoms, including excessive daytime sleepiness (EDS) and number of cataplexy episodes.

The study will enroll up to 160 patients from controlled studies conducted with TAK-861. Participants will be assigned to one of the treatment groups according to the dose assigned to them in their parent study. Similarly, participants who were previously on a placebo dose will also be assigned to one of the treatment groups randomly. All participants in the study will receive TAK-861.

Participants with NT1 will receive the following dose from the parent study:

• TAK-861 Dose 1

• TAK-861 Dose 2

• TAK-861 Dose 3

• TAK-861 Dose 4 Participants with NT2 will receive either TAK-861 Dose 1 or TAK-861 Dose 2 from the parent study.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 108 weeks. Participants will make multiple visits to the clinic (with some visits optionally conducted by home health), and will have a follow up assessment 4 weeks after last dose of study drug.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion criteria:

1. Participant with a diagnosis of narcolepsy who has completed a controlled study with TAK-861 (including participants diagnosed with NT1 or NT2) and for whom the investigator has no clinical objection to their enrollment.

Exclusion criteria:

1. Participant has a moderate or severe ongoing treatment emergent adverse event (TEAE) related to the study drug from the parent study or discontinued because of TEAEs in the parent study.

2. Participant has a positive urine screen for drugs of abuse (findings confirmed) and/or positive alcohol test during any visit in their prior TAK-861 study, or during the screening period for participants with a dosing gap.

3. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) on any visit in the parent TAK-861 study, or has positive answers on item 4 or 5 on the Screening/Baseline C-SSRS Lifetime (based on the past year) during the screening assessment for participants with a dosing gap.

4. Participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN) at multiple visits in the parent study and the findings are of clinical significance, per investigator or sponsor opinion, or ALT/AST >1.5 times ULN during the screening period for participants with a dosing gap.

5. Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).

6. Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.

7. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention).

8. Participant has epilepsy or history of seizure.

9. Participant has any other medical condition, such as anxiety, depression, heart disease, or significant hepatic, pulmonary, or renal disease, that requires them to take excluded medications.

10. Participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), or cerebral hemorrhage.

11. Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.

12. Participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment, or basal cell skin cancer.

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Narcolepsy
• Narcolepsy Type 1

Intervention

Drug:
• TAK-861
TAK-861 tablets

Locations

Country	Name	City	State
Australia	Woolcock Institute of Medical Research	Glebe	New South Wales
Finland	Terveystalo Helsinki Sleep Clinic	Helsinki	Uusimaa
France	CHU de Grenoble	La Tronche	Isere
France	CHU Gui De Chauliac	Montpellier	Herault
France	Hopital de la Pitie Salpetriere	Paris
France	Hopital Pierre-Paul Riquet	Toulouse	Haute-Garonne
Germany	Charite - Universitatsmedizin Berlin	Berlin
Germany	Klinische Forschung Hamburg	Hamburg
Germany	Universitaet Regensburg am Bezirksklinikum	Regensburg	Bayern
Germany	Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH	Schwerin	Mecklenburg-Vorpommern
Italy	Ospedale Bellaria	Bellaria
Italy	Istituto Neurologico Mediterraneo Neuromed	Pozzilli	Molise
Italy	Fondazione PTV Policlinico Tor Vergata	Roma	Lazio
Japan	Koishikawa Tokyo Hospital	Bunkyo-Ku	Tokyo
Japan	Howakai Kuwamizu Hospital	Kumamoto-Shi	Kumamoto
Japan	Kurume University Hospital	Kurume-Shi	Hukuoka
Japan	Aichi Medical University Hospital	Nagakute
Japan	YOU ARIYOSHI Sleep Clinic	Nagasaki-Shi	Nagasaki
Japan	Gokeikai Osaka Kaisei Hospital	Osaka-Shi	Osaka
Netherlands	Slaap-Waakcentrum SEIN Heemstede	Heemstede	Noord-Holland
Netherlands	Kempenhaeghe - PPDS	Heeze	Noord-Brabant
Norway	University of Oslo	Oslo
Spain	Hospital de La Ribera	Alzira	Valencia
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitario Vall d'Hebron - PPDS	Barcelona
Spain	Hospital General de Castello	Castellón De La Plana	Castellon
Spain	Hospital Vithas Madrid Arturo Soria	Madrid
Spain	Instituto de Investigaciones del Sueno	Madrid
Spain	Hospital Universitario Araba Santiago	Vitoria	Alava
Sweden	Sahlgrenska University Hospital	Goteborg	Vastra Gotalands Lan
Switzerland	Klinik Barmelweid AG	Barmelweid	Aargau (de)
Switzerland	Universitaetsspital Bern - Inselspital	Bern
Switzerland	Neurocenter of Southern Switzerland	Lugano	Ticino (it)
United States	Neurotrials Research	Atlanta	Georgia
United States	Sleep Disorders Center of Alabama	Birmingham	Alabama
United States	Medical University of South Carolina - PPDS	Charleston	South Carolina
United States	CTI Research Center	Cincinnati	Ohio
United States	Intrepid Research	Cincinnati	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Delta Waves LLC - Hunt - PPDS	Colorado Springs	Colorado
United States	Bogan Sleep Consultants, LLC	Columbia	South Carolina
United States	Research Carolina Elite	Denver	North Carolina
United States	Ohio Sleep Medicine Institute	Dublin	Ohio
United States	Georgia Neuro Center	Gainesville	Georgia
United States	ARSM Research, LLC	Huntersville	North Carolina
United States	Neurocare Inc	Newton	Massachusetts
United States	Children's Specialty Group	Norfolk	Virginia
United States	Henry Ford Medical Center - Columbus	Novi	Michigan
United States	Florida Pediatric Research Institute	Orlando	Florida
United States	Stanford Center for Sleep Sciences and Medicine	Redwood City	California
United States	Sleep Therapy and Research Center	San Antonio	Texas
United States	SDS Clinical Trials, Inc.	Santa Ana	California

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

United States,  Australia,  Finland,  France,  Germany,  Italy,  Japan,  Netherlands,  Norway,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.	From signing the informed consent form up to follow-up of 4 weeks after the last dose (Up to approximately 108 weeks)
Secondary	Change from Baseline in the Parent Study in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)	The MWT evaluates a person's ability to remain awake under soporific conditions. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions done 2 hours apart. Sleep latency in each session will be recorded. Participants will be required to stay awake in between the 4 sessions.	Baseline (parent study), Week 26 (current long-term extension [LTE] study)
Secondary	Change from Baseline in the Parent Study in Epworth Sleepiness Scale (ESS) Total Score	The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range.	Baseline (parent study); Week 2 through Week 105 (current LTE study)
Secondary	Change from Baseline in the Parent Study in Weekly Cataplexy Rate (WCR) Using the Patient-reported Cataplexy Diary for Participants With NT1	Participants with NT1 will complete a daily patient-reported sleep diary to record self-reported narcolepsy symptoms. Participants will record episodes of cataplexy in the diary for over 2-week periods throughout the study.	Baseline (parent study); Week 10 through Week 105 (current LTE study)

External Links

•   To obtain more information on the study, click here/on this link.