Clinical Trial Results:
Multi-center, single-arm, open-label study in patients with Insomnia Disorder to validate the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™)
|
Summary
|
|
EudraCT number |
2016-004259-59 |
Trial protocol |
DE |
Global end of trial date |
12 Jun 2017
|
|
Results information
|
|
Results version number |
v1 |
This version publication date |
28 Jun 2018
|
First version publication date |
28 Jun 2018
|
Other versions |
v2 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
AC-078A203
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT03056053 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Actelion Pharmaceuticals Ltd
|
||
Sponsor organisation address |
Hegenheimermattweg 95, Allschwil, Switzerland, 4123
|
||
Public contact |
Clinical Trials Disclosure Desk, Idorsia Pharmaceuticals Ltd, clinical-trials-disclosure@idorsia.com
|
||
Scientific contact |
Clinical Trials Disclosure Desk, Idorsia Pharmaceuticals Ltd, clinical-trials-disclosure@idorsia.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
27 Jun 2017
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
21 Apr 2017
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
12 Jun 2017
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
The main study objective was to assess the content validity and the psychometric characteristics of the IDSIQ™ and evaluate its appropriateness for use in the population of patients with insomnia disorder.
|
||
Protection of trial subjects |
An Independent Ethics Committee (IEC) or Institutional Review Board (IRB), i.e., a review panel that was responsible for ensuring the protection of the rights, safety and wellbeing of human subjects involved in a clinical investigation.
Sponsor personnel and the investigators ensured that the study was conducted in full compliance with ICH-Good Clinical Practice (GCP) Guidelines, the principles of the “Declaration of Helsinki”, and with the laws and regulations of the countries in which the study was conducted.
Prior to any study procedure and after adequate explanation of the aims, methods, objectives, and potential hazards of the study, written informed consent was obtained from each participating subject. Subjects could voluntarily withdraw from the study without justification for any reason at any time.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Jan 2017
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United States: 58
|
||
Country: Number of subjects enrolled |
Germany: 56
|
||
Worldwide total number of subjects |
114
|
||
EEA total number of subjects |
56
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
103
|
||
From 65 to 84 years |
11
|
||
85 years and over |
0
|
||
|
|||||||||||||
|
Recruitment
|
|||||||||||||
Recruitment details |
- | ||||||||||||
|
Pre-assignment
|
|||||||||||||
Screening details |
The screening period lasted at least 14 days, from signature of informed consent at Visit 1 (Day –14) up to subject enrollment at Visit 2. | ||||||||||||
|
Period 1
|
|||||||||||||
Period 1 title |
Overall study (overall period)
|
||||||||||||
Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
|
||||||||||||
Blinding used |
Not blinded | ||||||||||||
|
Arms
|
|||||||||||||
|
Arm title
|
Zolpidem | ||||||||||||
Arm description |
Treatment with open-label zolpidem according to prescription. | ||||||||||||
Arm type |
Reference treatment | ||||||||||||
Investigational medicinal product name |
Zolpidem
|
||||||||||||
Investigational medicinal product code |
|||||||||||||
Other name |
|||||||||||||
Pharmaceutical forms |
Tablet
|
||||||||||||
Routes of administration |
Oral use
|
||||||||||||
Dosage and administration details |
Commercially available zolpidem (5 or 10 mg) was administered orally once daily during the treatment period following prescribing information from each country participating in the trial (Germany and the US).
|
||||||||||||
|
|||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall study
|
|||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Zolpidem
|
||
Reporting group description |
Treatment with open-label zolpidem according to prescription. | ||
|
|||||||||
End point title |
IDSIQ™ Total Score-Change from Day 1 to Day 14/15 [1] | ||||||||
End point description |
NOTE: The primary study objective was to validate a new scale. The endpoints were the items of the IDSIQ™.
The Attachment provided below describes the Conceptual Framework of the study (Figure 1) and the Responsiveness of the IDSIQ™ (Total Score) from Day 1 to Day 14/15 (Table 1).
IDSIQ™ Total Score (Weekly Average); IDSIQ™ = Insomnia Daytime Symptoms and Impacts Questionnaire™
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Day 1 to Day 14/15
|
||||||||
| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was planned for this endpoint. |
|||||||||
|
|||||||||
Attachments |
ACT-541468 - AC-078A203_Attachment |
||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
IDSIQ™ Alert/Cognition Domain_Change from Day 1 to Day 14/15 | ||||||||
End point description |
|||||||||
End point type |
Other pre-specified
|
||||||||
End point timeframe |
Day 1 to Day 14/15
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
IDSIQ™ Mood Domain_Change from Day 1 to Day 14/15 | ||||||||
End point description |
|||||||||
End point type |
Other pre-specified
|
||||||||
End point timeframe |
Day 1 to Day 14/15
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
IDSIQ™ Sleepiness Domain_Change from Day 1 to Day 14/15 | ||||||||
End point description |
IDSIQ™ Sleepiness Domain (Weekly Average); IDSIQ™ = Insomnia Daytime Symptoms and Impacts Questionnaire™
|
||||||||
End point type |
Other pre-specified
|
||||||||
End point timeframe |
Day 1 to Day 14/15
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Adverse events were collected from the Screening Start (Day -14) to the Safety Follow-up (Day 45).
Below, data are reported for treatment-emergent adverse events (TEAEs).
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Zolpidem
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Zolpidem | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
