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Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03679884
Recruitment Status : Completed
First Posted : September 21, 2018
Results First Posted : March 2, 2022
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Insomnia Disorder
Interventions Drug: Daridorexant 10 mg
Drug: Daridorexant 25 mg
Drug: Daridorexant 50 mg
Drug: Placebo
Enrollment 804
Recruitment Details Ninety-four sites in 14 countries (Belgium, Bulgaria, Canada, Denmark, Finland, France, Germany, Hungary, South Korea, Poland, Spain, Sweden, Switzerland, and the US) enrolled and randomized subjects.
Pre-assignment Details

Subjects assigned to the daridorexant arms in Study ID-078A301 and 302 received the same dose in the ID-078A303 extension study. Subjects assigned to the placebo arm in Study ID-078A301 and 302 were re-randomized to receive either placebo or 25 mg daridorexant in a 1:1 ratio, with treatment allocation stratified by age into 2 categories (< 65 and ≥ 65 years).

Note: Subjects' demographic and baseline characteristics were collected in the respective confirmatory 12-week study (ID-078A301 or 302).

Arm/Group Title Daridorexant 10 mg Daridorexant 25 mg Daridorexant 50 mg Placebo ExPlacebo/Daridorexant 25 mg
Hide Arm/Group Description

Film-coated tablets administered orally, once daily in the evening

Daridorexant 10 mg: Daridorexant 10 mg tablets

Film-coated tablets administered orally, once daily in the evening

Daridorexant 25 mg: Daridorexant 25 mg tablets

Film-coated tablets administered orally, once daily in the evening

Daridorexant 50 mg: Daridorexant 50 mg tablets

Film-coated tablets administered orally, once daily in the evening

Placebo: Daridorexant matching placebo tablets

Film-coated tablets administered orally, once daily in the evening

Daridorexant 25 mg: Daridorexant 25 mg tablets

Period Title: Overall Study
Started [1] 142 268 137 128 126
Completed [1] 99 190 93 78 90
Not Completed 43 78 44 50 36
Reason Not Completed
Other             12             12             12             7             8
Lack of Efficacy             15             29             13             29             10
Death             1             0             0             0             0
Adverse Event             2             10             9             6             6
Withdrawal by Subject             12             23             8             8             9
Lost to Follow-up             1             4             2             0             3
[1]
DB treatment period
Arm/Group Title Daridorexant 10 mg Daridorexant 25 mg Daridorexant 50 mg Placebo ExPlacebo/Daridorexant 25 mg Total
Hide Arm/Group Description

Film-coated tablets administered orally, once daily in the evening

Daridorexant 10 mg: Daridorexant 10 mg tablets

Film-coated tablets administered orally, once daily in the evening

Daridorexant 25 mg: Daridorexant 25 mg tablets

Film-coated tablets administered orally, once daily in the evening

Daridorexant 50 mg: Daridorexant 50 mg tablets

Film-coated tablets administered orally, once daily in the evening

Placebo: Daridorexant matching placebo tablets

Film-coated tablets administered orally, once daily in the evening

Daridorexant 25 mg: Daridorexant 25 mg tablets

Total of all reporting groups
Overall Number of Baseline Participants 142 270 137 128 127 804
Hide Baseline Analysis Population Description
These are the participants included in the FAS. The discrepancy with previous table (Participant Flow) is due to 3 subjects on FAS (2 on daridorexant 25 mg and 1 on ex-placebo/ daridorexant 25 mg) not starting DB treatment.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 270 participants 137 participants 128 participants 127 participants 804 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
80
  56.3%
166
  61.5%
83
  60.6%
70
  54.7%
70
  55.1%
469
  58.3%
>=65 years
62
  43.7%
104
  38.5%
54
  39.4%
58
  45.3%
57
  44.9%
335
  41.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 142 participants 270 participants 137 participants 128 participants 127 participants 804 participants
58.6  (12.8) 57.6  (14.1) 56.9  (13.6) 59.2  (12.6) 56.5  (15.5) 57.7  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 270 participants 137 participants 128 participants 127 participants 804 participants
Female
103
  72.5%
199
  73.7%
98
  71.5%
92
  71.9%
83
  65.4%
575
  71.5%
Male
39
  27.5%
71
  26.3%
39
  28.5%
36
  28.1%
44
  34.6%
229
  28.5%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 270 participants 137 participants 128 participants 127 participants 804 participants
Black or African American
6
   4.2%
19
   7.0%
15
  10.9%
8
   6.3%
7
   5.5%
55
   6.8%
American Indian or Alaska Native
2
   1.4%
0
   0.0%
1
   0.7%
0
   0.0%
0
   0.0%
3
   0.4%
Native Hawaiian or other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
0
   0.0%
1
   0.1%
Asian
5
   3.5%
8
   3.0%
0
   0.0%
2
   1.6%
5
   3.9%
20
   2.5%
White
128
  90.1%
243
  90.0%
121
  88.3%
115
  89.8%
115
  90.6%
722
  89.8%
Other
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.6%
0
   0.0%
2
   0.2%
Not permitted as per legislation/regulation
1
   0.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.1%
[1]
Measure Description: Race
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 270 participants 137 participants 128 participants 127 participants 804 participants
Hispanic or Latino
6
   4.2%
33
  12.2%
19
  13.9%
10
   7.8%
13
  10.2%
81
  10.1%
Not Hispanic or Latino
135
  95.1%
237
  87.8%
118
  86.1%
118
  92.2%
114
  89.8%
722
  89.8%
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not permitted as per legislation/regulation
1
   0.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.1%
[1]
Measure Description: Ethnicity
1.Primary Outcome
Title Total no. of Subjects With at Least One TEAE
Hide Description

The primary objective of the study was to assess the long-term safety and tolerability of 10, 25 and 50 mg daridorexant.

The total no. of subjects with at least one TEAE is presented here; no statistical analysis was conducted.

The full set of safety data is available in the Section "Adverse events".

Time Frame TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daridorexant 10 mg Daridorexant 25 mg Daridorexant 50 mg Placebo ExPlacebo / Daridorexant 25 mg
Hide Arm/Group Description:

Film-coated tablets administered orally, once daily in the evening

Daridorexant 10 mg: Daridorexant 10 mg tablets

Film-coated tablets administered orally, once daily in the evening

Daridorexant 25 mg: Daridorexant 25 mg tablets

Film-coated tablets administered orally, once daily in the evening

Daridorexant 50 mg: Daridorexant 50 mg tablets

Film-coated tablets administered orally, once daily in the evening

Placebo: Daridorexant matching placebo tablets

Film-coated tablets administered orally, once daily in the evening

Daridorexant 25 mg: Daridorexant 25 mg tablets

Overall Number of Participants Analyzed 142 268 137 128 126
Measure Type: Count of Participants
Unit of Measure: Participants
53
  37.3%
103
  38.4%
55
  40.1%
45
  35.2%
48
  38.1%
Time Frame All treatment-emergent SAEs and AEs are reported.
Adverse Event Reporting Description TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
 
Arm/Group Title Daridorexant 10 mg Daridorexant 25 mg Daridorexant 50 mg Placebo Ex-Placebo Daridorexant 25 mg
Hide Arm/Group Description

Film-coated tablets administered orally, once daily in the evening

Daridorexant 10 mg: Daridorexant 10 mg tablets

Film-coated tablets administered orally, once daily in the evening

Daridorexant 25 mg: Daridorexant 25 mg tablets

Film-coated tablets administered orally, once daily in the evening

Daridorexant 50 mg: Daridorexant 50 mg tablets

Film-coated tablets administered orally, once daily in the evening

Placebo: Daridorexant matching placebo tablets

Film-coated tablets administered orally, once daily in the evening

Daridorexant 25 mg: Daridorexant 25 mg tablets

All-Cause Mortality
Daridorexant 10 mg Daridorexant 25 mg Daridorexant 50 mg Placebo Ex-Placebo Daridorexant 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/142 (0.70%)      1/268 (0.37%)      0/137 (0.00%)      0/128 (0.00%)      0/126 (0.00%)    
Hide Serious Adverse Events
Daridorexant 10 mg Daridorexant 25 mg Daridorexant 50 mg Placebo Ex-Placebo Daridorexant 25 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/142 (3.52%)      12/268 (4.48%)      7/137 (5.11%)      2/128 (1.56%)      4/126 (3.17%)    
Cardiac disorders           
Aortic valve disease mixed *  0/142 (0.00%)  0 0/268 (0.00%)  0 0/137 (0.00%)  0 0/128 (0.00%)  0 1/126 (0.79%)  1
Bundle branch block left *  0/142 (0.00%)  0 1/268 (0.37%)  1 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
Coronary artery stenosis *  0/142 (0.00%)  0 1/268 (0.37%)  1 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
Myocardial infarction *  1/142 (0.70%)  1 1/268 (0.37%)  1 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
Endocrine disorders           
Thyroiditis subacute *  0/142 (0.00%)  0 0/268 (0.00%)  0 1/137 (0.73%)  1 0/128 (0.00%)  0 0/126 (0.00%)  0
Gastrointestinal disorders           
Nausea *  0/142 (0.00%)  0 1/268 (0.37%)  1 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
Vomiting *  0/142 (0.00%)  0 1/268 (0.37%)  1 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
General disorders           
Chest discomfort *  0/142 (0.00%)  0 0/268 (0.00%)  0 0/137 (0.00%)  0 0/128 (0.00%)  0 1/126 (0.79%)  1
Chest pain *  0/142 (0.00%)  0 1/268 (0.37%)  1 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
Influenza like illness *  0/142 (0.00%)  0 0/268 (0.00%)  0 1/137 (0.73%)  1 0/128 (0.00%)  0 0/126 (0.00%)  0
Infections and infestations           
Appendicitis *  0/142 (0.00%)  0 0/268 (0.00%)  0 0/137 (0.00%)  0 0/128 (0.00%)  0 1/126 (0.79%)  1
Bronchitis *  0/142 (0.00%)  0 1/268 (0.37%)  1 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
Diverticulitis *  0/142 (0.00%)  0 2/268 (0.75%)  2 1/137 (0.73%)  1 0/128 (0.00%)  0 0/126 (0.00%)  0
Pneumonia *  0/142 (0.00%)  0 0/268 (0.00%)  0 1/137 (0.73%)  1 0/128 (0.00%)  0 0/126 (0.00%)  0
Injury, poisoning and procedural complications           
Alcohol poisoning *  0/142 (0.00%)  0 1/268 (0.37%)  2 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
Head injury *  0/142 (0.00%)  0 0/268 (0.00%)  0 0/137 (0.00%)  0 1/128 (0.78%)  1 0/126 (0.00%)  0
Subdural haematoma *  0/142 (0.00%)  0 0/268 (0.00%)  0 0/137 (0.00%)  0 1/128 (0.78%)  1 0/126 (0.00%)  0
Wrist fracture *  0/142 (0.00%)  0 0/268 (0.00%)  0 1/137 (0.73%)  1 0/128 (0.00%)  0 0/126 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Bone disorder *  0/142 (0.00%)  0 0/268 (0.00%)  0 1/137 (0.73%)  1 0/128 (0.00%)  0 0/126 (0.00%)  0
Intervertebral disc protrusion *  1/142 (0.70%)  1 0/268 (0.00%)  0 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
Spinal stenosis *  0/142 (0.00%)  0 1/268 (0.37%)  1 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Breast cancer *  2/142 (1.41%)  2 0/268 (0.00%)  0 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
Chronic lymphocytic leukaemia *  0/142 (0.00%)  0 0/268 (0.00%)  0 1/137 (0.73%)  1 0/128 (0.00%)  0 0/126 (0.00%)  0
Lung cancer metastatic *  0/142 (0.00%)  0 1/268 (0.37%)  1 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
Nervous system disorders           
Cerebrovascular accident *  1/142 (0.70%)  1 0/268 (0.00%)  0 0/137 (0.00%)  0 0/128 (0.00%)  0 1/126 (0.79%)  1
Lethargy *  0/142 (0.00%)  0 1/268 (0.37%)  1 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
Orthostatic intolerance *  0/142 (0.00%)  0 1/268 (0.37%)  1 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
Psychiatric disorders           
Confusional state *  0/142 (0.00%)  0 1/268 (0.37%)  1 1/137 (0.73%)  1 0/128 (0.00%)  0 0/126 (0.00%)  0
Depression *  0/142 (0.00%)  0 0/268 (0.00%)  0 0/137 (0.00%)  0 1/128 (0.78%)  1 0/126 (0.00%)  0
Mental status changes *  0/142 (0.00%)  0 1/268 (0.37%)  1 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
Suicidal ideation *  0/142 (0.00%)  0 0/268 (0.00%)  0 0/137 (0.00%)  0 1/128 (0.78%)  1 0/126 (0.00%)  0
Reproductive system and breast disorders           
Ovarian cyst *  0/142 (0.00%)  0 1/268 (0.37%)  1 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Pulmonary mass *  0/142 (0.00%)  0 1/268 (0.37%)  1 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
Vascular disorders           
Arteriosclerosis *  0/142 (0.00%)  0 1/268 (0.37%)  1 0/137 (0.00%)  0 0/128 (0.00%)  0 0/126 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daridorexant 10 mg Daridorexant 25 mg Daridorexant 50 mg Placebo Ex-Placebo Daridorexant 25 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/142 (4.93%)      15/268 (5.60%)      12/137 (8.76%)      6/128 (4.69%)      11/126 (8.73%)    
Infections and infestations           
Nasopharyngitis   7/142 (4.93%)  10 15/268 (5.60%)  16 12/137 (8.76%)  13 6/128 (4.69%)  6 11/126 (8.73%)  11
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any study-related publication written independently by investigators must be submitted to Idorsia for review at least 30 days prior to submission for publication or presentation at a congress. Upon review, Idorsia may provide comments, and may also request alterations and/or deletions for the sole purpose of protecting its confidential information and/or patent rights. Neither the institution nor the investigator should permit publication during such a review period.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosure Desk
Organization: Idorsia Pharmaceuticals Ltd
Phone: +41 58 844 00 00
EMail: clinical-trials-disclosure@idorsia.com
Layout table for additonal information
Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03679884    
Other Study ID Numbers: ID-078A303
First Submitted: September 19, 2018
First Posted: September 21, 2018
Results First Submitted: January 7, 2022
Results First Posted: March 2, 2022
Last Update Posted: March 2, 2022