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A Study of TAK-994 in Adults With Narcolepsy

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ClinicalTrials.gov Identifier: NCT04820842
Recruitment Status : Recruiting
First Posted : March 29, 2021
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:

Adults with narcolepsy who have completed the TAK-994-1501 study will be able to take part in this study.

The main aim of this study is to check if participants have side effects from TAK-994.

Participants will take one of 3 different TAK-994 dose for 8 weeks.

Then, half the participants will continue with their dose of TAK-994 and half will take a placebo. In this study, a placebo will look like a TAK-994 tablet but will not have any medicine in it. Participants will take TAK-994 or placebo for 4 weeks.

Participants will visit the clinic for a final check-up 2 weeks after their last dose of TAK-994 or placebo.

The study doctors will check for side effects from TAK-994 and placebo throughout the study.

Participants will continue to record any narcolepsy symptoms as they did in Part B of the TAK 994 1501 study.


Condition or disease Intervention/treatment Phase
Narcolepsy Type 1 (NT 1) Drug: TAK-994 Drug: Placebo Phase 2

Detailed Description:

The drug being tested in the study is called TAK-994. TAK-994, is being tested to treat participants with NT1. Participants who completed Part B of TAK-994-1501(NCT04096560) will be eligible for enrollment in this study.

This study will enroll approximately 112 patients to receive one of three different TAK 994 dose for 8 weeks (active drug extension period). Participants will be randomly assigned to one of these different TAK 994 doses which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).

Following the 8-week Active Drug Extension Period, participants will continue into a 4-week Double-blind Randomized Withdrawal Period and will receive TAK-994 or Placebo. Participants randomized to TAK-994 will continue to receive the same dose as before.

This multi-center trial will be conducted worldwide. The duration of treatment in this study is 12 weeks plus a 2 week safety follow up period Participants will visits the clinic 10 times after the first dosing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose-Blind Extension Study With Double-blind, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Safety and Explore the Pharmacokinetics and Pharmacodynamics of TAK-994 in Adults With Narcolepsy With Cataplexy (Narcolepsy Type 1)
Actual Study Start Date : April 30, 2021
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Drug Extension Period: TAK-994 Dose 1
TAK-994 dose 1, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56.
Drug: TAK-994
TAK-994 tablets.

Experimental: Active Drug Extension Period: TAK-994 Dose 2
TAK-994 dose 2, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56.
Drug: TAK-994
TAK-994 tablets.

Experimental: Active Drug Extension Period: TAK-994 Dose 3
TAK-994 dose 3, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56.
Drug: TAK-994
TAK-994 tablets.

Experimental: Double-blind Randomized Withdrawal Period: TAK-994 Dose 1
Following the Active Drug Extension Period, participants randomized to active treatment Dose 1 will continue to receive same dose (TAK-994, dose 1, tablets, orally) from Day 57 to Day 84.
Drug: TAK-994
TAK-994 tablets.

Experimental: Double-blind Randomized Withdrawal Period: TAK-994 Dose 2
Following the Active Drug Extension Period, participants randomized to active treatment Dose 2 will continue to receive same dose (TAK-994, dose 2, tablets, orally) from Day 57 to Day 84.
Drug: TAK-994
TAK-994 tablets.

Experimental: Double-blind Randomized Withdrawal Period: TAK-994 Dose 3
Following the Active Drug Extension Period, participants randomized to active treatment Dose 3 will continue to receive same dose (TAK-994, dose 3, tablets, orally) from Day 57 to Day 84.
Drug: TAK-994
TAK-994 tablets.

Placebo Comparator: Double-blind Randomized Withdrawal Period: Placebo
Following the Active Drug Extension Period participants will receive placebo-matching tablets for 4 weeks (from Day 57 to Day 84).
Drug: Placebo
Placebo-matching tablets.




Primary Outcome Measures :
  1. Number of Participants with at Least One Treatment Emergent Adverse Event (TEAE) During the Active Drug Extension Period [ Time Frame: Up to Week 8 ]
    An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participants 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 (example, 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 AE with an onset that occurs after receiving study drug.

  2. Number of Participants with at Least One Post-dose Markedly Abnormal Value (MAV) in Laboratory Test During the Active Drug Extension Period [ Time Frame: Baseline up to Week 8 ]
    Markedly abnormal values for laboratory tests (hematology, serum chemistries, and urinalysis) will be collected as per pre-specified criteria.

  3. Number of Participants with at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period [ Time Frame: Baseline up to Week 8 ]
    Markedly abnormal values for vital signs (body temperature, heart rate, respiratory rate, sitting blood pressure and pulse) will be collected as per pre-specified criteria.

  4. Number of Participants with at Least One Post-dose MAV for Electrocardiogram (ECG) Parameters During the Active Drug Extension Period [ Time Frame: Baseline up to Week 8 ]
    A 12 lead ECG will be performed and markedly abnormal values. will be collected as per pre-specified criteria.


Secondary Outcome Measures :
  1. Number of Participants with at Least One TEAE During the Randomized Withdrawal Period of the Study. [ Time Frame: Weeks 8 to 14 ]
    An AE is defined as any untoward medical occurrence in a clinical investigation participants 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, 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 AE with an onset that occurs after receiving study drug.

  2. Number of Participants with at Least One Post-dose MAV for Laboratory Test During the Randomized Withdrawal Period [ Time Frame: Weeks 8 to 14 ]
    Markedly abnormal values for laboratory tests for (hematology, serum chemistries, and urinalysis) will be collected as per pre-specified criteria.

  3. Number of Participants with at Least One Post-dose MAV for Vital Signs During the Randomized Withdrawal Period [ Time Frame: Weeks 8 to 14 ]
    Markedly abnormal values (body temperature, heart rate, respiratory rate, sitting blood pressure and pulse) will be collected as per pre-specified criteria.

  4. Number of Participants with at Least One Post-dose MAV for ECG Parameters During the Randomized Withdrawal Period [ Time Frame: Weeks 8 to 12 ]
    A 12 lead ECG will be performed and markedly abnormal values will be collected as per pre-specified criteria.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Participant with a diagnosis of Narcolepsy Type 1 (NT1) who has completed TAK-994-1501 Part B before enrollment (which will occur immediately following the final TAK-994-1501 assessments), and for whom the investigator has no clinical objection they be enrolled.

Exclusion Criteria:

1. Participant has a clinically significant moderate or severe ongoing AE related to the study drug from the prior study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04820842


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medinfoUS@takeda.com

Locations
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Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director, Clinical Science Takeda
Additional Information:
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT04820842    
Other Study ID Numbers: TAK-994-1504
2021-000251-39 ( EudraCT Number )
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders