Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder

PHASE2CompletedINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

October 4, 2016

Primary Completion Date

April 12, 2017

Study Completion Date

June 20, 2017

Conditions
Insomnia Disorder
Interventions
DRUG

ACT-541468 5 mg

Capsule for oral administration containing ACT-541468 at a strength of 5 mg

DRUG

ACT-541468 10 mg

Capsule for oral administration containing ACT-541468 at a strength of 10 mg

DRUG

ACT-541468 25 mg

Capsule for oral administration containing ACT-541468 at a strength of 25 mg

DRUG

Zolpidem

Over-encapsulated zolpidem tablet at a strength of 10 mg

DRUG

Placebo 1

Placebo capsules matching ACT-541468 capsules

DRUG

Placebo 2

Placebo capsules matching over-encapsulated zolpidem

Trial Locations (35)

1134

Investigator Site, Budapest

2045

Investigator Site, Törökbálint

6725

Investigator Site, Szeged

10019

Investigator Site, New York

10115

Investigator Site, Berlin

10117

Investigator Site, Berlin

12203

Investigator Site, Berlin

19053

Investigator Site, Schwerin

19055

Investigator Site, Schwerin

20251

Investigator Site, Hamburg

20253

Investigator Site, Hamburg

28036

Investigator Site, Madrid

30159

Investigator Site, Hanover

30342

Investigator Site, Atlanta

31096

Investigator Site, Haifa

32720

Investigator Site, DeLand

33024

Investigator Site, Hollywood

33134

Investigator Site, Coral Gables

33143

Investigator Site, Miami

33511

Investigator Site, Brandon

33765

Investigator Site, Clearwater

45255

Investigator Site, Cincinnati

46250

Investigator Site, Indianapolis

48377

Investigator Site, Novi

50015

Investigator Site, Zaragoza

60634

Investigator Site, Chicago

84101

Investigator Site, Beersheba

89104

Investigator Site, Las Vegas

90404

Investigator Site, Santa Monica

91786

Investigator Site, Upland

01069

Investigator Site, Dresden

08017

Investigator Site, Barcelona

08035

Investigator Site, Barcelona

413 90

Investigator Site, Gothenburg

701 85

Investigator Site, Örebro

Sponsors
All Listed Sponsors
lead

Idorsia Pharmaceuticals Ltd.

INDUSTRY