Narcolepsy Type 1 (NT 1)
Conditions
Interventions
Active Drug Extension Period: TAK-994 Dose 1 - 3
TAK-994 dose 1 - 3, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56.
Double-blind Randomized Withdrawal Period: TAK-994 Dose 1 - 3
Fo
Sponsors
Nonomura Hidenori
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: 1. Participant has a clinically significant moderate or severe ongoing adverse event (AE) related to the study drug from the prior study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 in the Active Drug Extension Period (Weeks 1 to 8) 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 (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: Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8) Clinical laboratory tests included hematology and serum chemistry, MAV criteria: Hemoglobin 1.2*upper limit of normal (ULN); Hematocrit 1.2*ULN; Red blood cells (RBC) count 1.2*ULN; White blood cells (WBC) count 1.5*ULN; Platelet count 600*10^9/L; alanine aminotransferase (ALT) >3*ULN; aspartate aminotransferase (AST) >3*ULN; gamma-glutamyl transferase (GGT) >3*ULN; Alkaline phosphatase >3*ULN; Total bilirubin >1.5*ULN; Albumin 1.2*ULN; Creatinine >1.5*ULN; Blood urea nitrogen >40 milligrams per decilitres (mg/Dl); Sodium 150 mEq/L; Potassium 5.3 mmol/L; creatine phosphokinase (CPK) >3*ULN; Glucose 300 mg/dL; Calcium 11.1 mg/dL. 3.Number of Participants with at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period Time Frame: Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8) MAV criteria for vital signs were: Pulse 115 bpm; Systolic blood pressure =160 mmHg; Diastolic blood pressure =100 mmHg, Systolic or Diastolic blood pressure change >20, >30 mmHg, Body temperature >38.5 degree Celsius, Respiratory R | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Number of Participants with at Least One TEAE During the Randomized Withdrawal Period Time Frame: Up to 4 weeks in the Randomized Withdrawal Period (Weeks 9 to 12) 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: Up to 4 weeks in the Randomized Withdrawal Period (Weeks 9 to 12) Clinical laboratory tests included hematology and serum chemistry, MAV criteria: Hemoglobin 1.2*upper limit of normal (ULN); Hematocrit 1.2*ULN; Red blood cells (RBC) count 1.2*ULN; White blood cells (WBC) count 1.5*ULN; Platelet count 600*10^9/L; alanine aminotransferase (ALT) >3*ULN; aspartate aminotransferase (AST) >3*ULN; gamma-glutamyl transferase (GGT) >3*ULN; Alkaline phosphatase >3*ULN; Total bilirubin >1.5*ULN; Albumin 1.2*ULN; Creatinine >1.5*ULN; Blood urea nitrogen >40 milligrams per decilitres (mg/Dl); Sodium 150 mEq/L; Potassium 5.3 mmol/L; creatine phosphokinase (CPK) >3*ULN; Glucose 300 mg/dL; Calcium 11.1 mg/dL. 3.Number of Participants with at Least One Post-dose MAV for Vital Signs During the Randomized Withdrawal Period Time Frame: Up to 4 weeks in the Randomized Withdrawal Period (Weeks 9 to 12) MAV criteria for vital signs were: Pulse 115 bpm; Systolic blood pressure =160 mmHg; Diastolic blood pressure =100 mmHg, Systolic or Diastolic blood pressure change >20, >30 mmHg, Body temperature >38.5 degree Celsius, Respiratory Rate >21 breath/minute. Baseline for this outcome measure is Day 1 of the Double-blind Randomized Withdrawal Period. 4.Nu | — |
Countries
Canada, Czech Republic, Finland, France, Hungary, Italy, Japan, Netherlands, South Korea, Spain, United States
Contacts
Public ContactTrial Information Contact for Clinical
Takeda Pharmaceutical Company Limited
Outcome results
None listed