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Trial record 52 of 179 for:    DCLRE1C

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

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ClinicalTrials.gov Identifier: NCT03679884
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief Summary:
Study to assess the long term safety and tolerability of ACT-541468 in adult and elderly subjects suffering from difficulties to sleep

Condition or disease Intervention/treatment Phase
Insomnia Disorder Drug: ACT-541468 10 mg Drug: ACT-541468 25 mg Drug: ACT-541468 50 mg Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-center, double-blind, parallel-group, randomized, placebo-controlled, three doses, 40-week extension study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center, Double-blind, Parallel-group, Randomized, Placebo-controlled, Three Doses, 40-week Extension to Studies ID-078A301 and ID-078A302 to Assess the Long Term Safety and Tolerability of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 16, 2020

Arm Intervention/treatment
Experimental: ACT-541468 10 mg
Tablets administered orally, once daily in the evening
Drug: ACT-541468 10 mg
ACT-541468 10 mg tablets

Experimental: ACT-541468 25 mg
Tablets administered orally, once daily in the evening
Drug: ACT-541468 25 mg
ACT-541468 25 mg tablets

Experimental: ACT-541468 50 mg
Tablets administered orally, once daily in the evening
Drug: ACT-541468 50 mg
ACT-541468 50 mg tablets

Placebo Comparator: Placebo
Tablets administered orally, once daily in the evening
Drug: Placebo
ACT-541468 matching placebo tablets




Primary Outcome Measures :
  1. Serious adverse events (SAEs) [ Time Frame: Duration for up to 45 weeks, i.e. from signed ICF up to 30 days after last dose of DB study treatment ]
  2. Treatment-emergent adverse events (TEAEs) [ Time Frame: Duration for up to 45 weeks, i.e. from signed ICF up to 30 days after last dose of DB study treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent prior to any study-mandated procedure (Visit 1).
  • Having completed the DB study treatment and the run-out period of ID-078A301 or ID‒078A302 (Visit 1).
  • For woman of childbearing potential, the following is required:

    • Negative urine pregnancy test (EOT of ID-078A301 or ID-078A302 studies)
    • Agreement to use the contraception scheme as required by the protocol from Visit 1 up to at least 30 days after EODBT.

Exclusion Criteria:

  • Unstable medical condition, significant medical disorder or acute illness, C-SSRS©, ECG, hematology or biochemistry test results in ID-078A301 and ID-078A302, which in the opinion of the investigator could affect the subject's safety or interfere with the study assessments (Visit 1).
  • For female subjects: lactating or planning to become pregnant during the duration of the study (Visit 1).
  • Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates, amphetamines, or cocaine) or presence of alcohol in exhaled breath as detected by breathalyzer test (EOT of ID-078A301 or ID-078A302 studies if same day as Visit 1 or Visit 1 if within 7 days after EOT).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679884


Contacts
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Contact: Clinical Trial Disclosure Desk +18566613721 clinical-trials-disclosure@idorsia.com

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Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.

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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03679884     History of Changes
Other Study ID Numbers: ID-078A303
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders