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NCT04096560 Clinical Trial

A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy

Narcolepsy Type 1 (NT1) Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 or Narcolepsy Type 2)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04096560
Other study ID # TAK-994-1501
Secondary ID JapicCTI-2051782
Status Terminated
Phase Phase 2
First received
Last updated
Start date February 27, 2020
Est. completion date November 5, 2021

Study information
Verified date March 2023
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main aims of the study are: - To check for side effects from TAK-994 and check what dose of TAK-994 participants can tolerate. - To check what dose range provides adequate relief of narcolepsy symptoms. - To check how much TAK-994 stays in the blood of participants, over time. The study will have 4 parts. Participants can only join 1 of the parts. A. Participants with type 1 narcolepsy will take either TAK-994 or placebo tablets for 28 days. A placebo looks just like TAK-994 but will not have any medicine in it. B. Participants with type 1 narcolepsy will take 1 of 3 doses of TAK-994 or placebo tablets for 56 days. C. Participants with type 1 narcolepsy in China only will take TAK-994 or placebo tablets for 56 days. D. Participants with type 2 narcolepsy will take either TAK-994 or placebo tablets for 28 days.

Description:

The drug being tested in this study is called TAK-994. TAK-994 is being tested in participants with NT1 and NT2. The study will enroll up to approximately 202 participants. The study has 4 Parts: Parts A, B, C (China only) and D. Part A - Part A has 2 cohorts [Cohorts (A1a and A1b) A2] In both of these Cohorts, participants will be randomly assigned (by chance, like flipping a coin) in a 2:1 ratio to receive TAK-994 or placebo up to 28 days: - Part B: In Part B, participants will be randomized in 1:1:1:1 ratio in four parallel arms to receive TAK-994 Dose 1, 2 or 3 or placebo for 56 days. Depending upon their eligibility participants completing Part B of the study treatment will be enrolled to participate in an Extension study. - Part C: In Part C, participants only from China will be enrolled and randomized in a 2:1 ratio to receive TAK-994 and placebo for 56 days. - Part D: Participants will be included in two cohorts [Cohorts (D1a and D1b) and D2] and will be randomized in 2:1 ratio to receive TAK-994 or placebo for 28 days. The dose will be selected based on the safety and tolerability in Part A. This multi-center trial will be conducted in the United States, Japan, China, Italy, France, and European Union. The overall duration of the study is 63 days. Participants will be followed up for 7 days after the last dose of study drug.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• TAK-994
TAK-994 tablets.
• Placebo
TAK-994 placebo-matching tablets.
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Sponsors (1)
Lead Sponsor Collaborator
Takeda

Countries where clinical trial is conducted

United States,  Canada,  China,  Czechia,  Finland,  France,  Hungary,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Parts A and D: Number of Participants who Experience at least 1 Treatment Emergent Adverse Events (TEAEs) During the Study 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 (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. First dose of study treatment to end of study follow-up (up to Day 35)
Primary Parts A and D: Number of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at least Once Postdose During the Study Standard safety laboratory values (serum chemistry, hematology, and urine analysis) will be collected and compared to pre-specified criteria for markedly abnormal values throughout the study. Baseline up to Day 35
Primary Parts A and D: Number of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at least Once Postdose During the Study Vital signs (body temperature, heart rate, respiratory rate, sitting blood pressure and pulse) will be collected and compared to pre-specified criteria for markedly abnormal values throughout the study. Baseline up to Day 35
Primary Parts A and D: Number of Participants who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at least Once Postdose During the Study A 12 lead ECG will be performed, the ECG values will be compared to pre-specified criteria for markedly abnormal values. Baseline up to Day 35
Primary Parts B and C: Change From Baseline in Average Sleep Latency as Assessed by the Maintenance of Wakefulness Test (MWT) The MWT is a validated, objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants will be instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session will be recorded on electroencephalography (EEG). If no sleep has been observed according to these rules, then the latency will be defined as 40 minutes. Baseline and Week 8 (Day 56)
Secondary Parts A and D: Day 1, Cmax: Maximum Observed Plasma Concentration After Single Dose of TAK-994 Day 1: Pre-dose and at multiple time points (Up to 14 hours) post-dose
Secondary Parts A and D: Day 1, Tmax: Time of First Occurrence of Cmax After Single Dose of TAK-994 Day 1: Pre-dose and at multiple time points (Up to 14 hours) post-dose
Secondary Parts A and D: Day 1, AUC(0-last): Area Under the Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration After Single Dose of TAK-994 Day 1: Pre-dose and at multiple time points (Up to 14 hours) post-dose
Secondary Parts A and D: Day 28, Cmax: Maximum Observed Plasma Concentration After Multiple Doses of TAK-994 Day 28: Pre-dose and at multiple time points (Up to 14 hours) post-dose
Secondary Parts A and D: Day 28, Tmax: Time of First Occurrence of Cmax After Multiple Doses of TAK-994 Day 28: Pre-dose and at multiple time points (Up to 14 hours) post-dose
Secondary Parts A and D: Day 28, AUC(0-t): Area Under the Concentration-time Curve from Time 0 to Time tau Over a Dosing Interval of TAK-994 Day 28: Pre-dose and at multiple time points (Up to 14 hours) post-dose
Secondary Parts B and C: Change From Baseline in Subjective Daytime Sleepiness as Assessed by ESS Score The ESS is a subjective, self-administered, validated scale (scored 0 to 3) to respond to each of the 8 questions of daily life that asks them how likely they are to fall asleep in those situations. 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 and Week 8 (Day 56)
Secondary Parts B and C: Change From Baseline in Weekly Cataplexy Rate (WCR) as Reported in the Patient-Reported Sleep Diary Participants will complete a daily patient-reported sleep diary to record self-reported narcolepsy symptoms. Participants will record episodes of cataplexy in the diary. The total number of events averaged for a week will be reported. Baseline and Week 8 (Day 56)
Secondary Parts B and C: Number of Participants who Experience at least 1 Treatment Emergent Adverse Events (TEAEs) During the Study 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 (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. First dose of study treatment to end of study follow-up (Up to Day 63)
Secondary Parts B and C: Number of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at least Once Postdose During the Study Standard safety laboratory values (serum chemistry, hematology, and urine analysis) will be collected and compared to pre-specified criteria for markedly abnormal values throughout the study. Baseline up to Day 63
Secondary Parts B and C: Number of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at least Once Postdose During the Study Vital signs (body temperature, heart rate, respiratory rate, sitting blood pressure and pulse) will be collected and compared to pre-specified criteria for markedly abnormal values throughout the study. Baseline up to Day 63
Secondary Parts B and C: Number of Participants who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at least Once Postdose During the Study A 12 lead ECG will be performed, the ECG values will be compared to pre-specified criteria for markedly abnormal values. Baseline up to Day 63
Secondary Change from Baseline in Sleep Latency as Assessed by the Maintenance of Wakefulness Test (MWT) The MWT is a validated, objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants will be instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session will be recorded on electroencephalography (EEG). If no sleep has been observed according to these rules, then the latency will be defined as 40 minutes. Baseline up to Week 4
Secondary Change From Baseline in Subjective Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS) Score The ESS is a subjective, self-administered, validated scale (scored 0 to 3) to respond to each of the 8 questions of daily life that asks them how likely they are to fall asleep in those situations. 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 up to Week 4
Secondary Parts A, B and C: Change From Baseline in Weekly Cataplexy Rate (WCR) as Reported in the Patient-Reported Sleep Diary Participants will complete a daily patient-reported sleep diary to record self-reported narcolepsy symptoms. Participants will record episodes of cataplexy in the diary. The total number of events per week will be calculated. Baseline up to Week 4
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06462404 - A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1 Phase 1

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