A Double-blind, Placebo-Controlled, Randomized Withdrawal Trial to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy with Cataplexy (Narcolepsy Type 1)

Conditions

Narcolepsy

Brief summary

Time to loss of responsea in the Epworth Sleepiness Scale (ESS) score during the up to 4-week RW period.

Detailed description

01. Change from the end of the Open-Label (OL) Treatment Period to Week 2 of the RW period in mean sleep latency on the MWT., 02. WCR at Week 2 of the RW period., 03. Change from the end of the OL treatment period to Week 2 of the RW period in number of lapses on the PVT., 04. Occurrence of reporting much or very much worse in PGI-C score at Week 2 of the RW period., 05. Change from the end of the OL treatment period to Week 2 of the RW period in NSS-CT total score., 06. Change from the end of the OL treatment period to Week 2 of the RW period in FINI domain scores for: tiredness, cognitive functioning, cataplexy, social activities, everyday activities, and everyday responsibilities., 07. Change from the end of the OL treatment period to Week 2 of the RW period in number of correct responses on the iDSST-s., 08. Occurrence of at least 1 TEAE during the OL treatment period and the RW period including the follow-up period, as applicable.

Related papers

No related papers found yet.

Interventions

DRUGTAK-861

DRUGImmediate release tablet; identical to TAK-861 IMP

DRUGwith the exception that active ingredient is replaced with mannitol

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to loss of responsea in the Epworth Sleepiness Scale (ESS) score during the up to 4-week RW period.	—

Secondary

Measure	Time frame
01. Change from the end of the Open-Label (OL) Treatment Period to Week 2 of the RW period in mean sleep latency on the MWT., 02. WCR at Week 2 of the RW period., 03. Change from the end of the OL treatment period to Week 2 of the RW period in number of lapses on the PVT., 04. Occurrence of reporting much or very much worse in PGI-C score at Week 2 of the RW period., 05. Change from the end of the OL treatment period to Week 2 of the RW period in NSS-CT total score., 06. Change from the end of the OL treatment period to Week 2 of the RW period in FINI domain scores for: tiredness, cognitive functioning, cataplexy, social activities, everyday activities, and everyday responsibilities., 07. Change from the end of the OL treatment period to Week 2 of the RW period in number of correct responses on the iDSST-s., 08. Occurrence of at least 1 TEAE during the OL treatment period and the RW period including the follow-up period, as applicable.	—

Measure

Time frame

01. Change from the end of the Open-Label (OL) Treatment Period to Week 2 of the RW period in mean sleep latency on the MWT., 02. WCR at Week 2 of the RW period., 03. Change from the end of the OL treatment period to Week 2 of the RW period in number of lapses on the PVT., 04. Occurrence of reporting much or very much worse in PGI-C score at Week 2 of the RW period., 05. Change from the end of the OL treatment period to Week 2 of the RW period in NSS-CT total score., 06. Change from the end of the OL treatment period to Week 2 of the RW period in FINI domain scores for: tiredness, cognitive functioning, cataplexy, social activities, everyday activities, and everyday responsibilities., 07. Change from the end of the OL treatment period to Week 2 of the RW period in number of correct responses on the iDSST-s., 08. Occurrence of at least 1 TEAE during the OL treatment period and the RW period including the follow-up period, as applicable.

—

Outcome results

None listed