Double-blind, randomized, placebo-controlled cross-over dose finding study of two doses of lorediplon in adult patients with insomnia disorder

FERRER INTERNACIONAL, S.A.0 sites130 target enrollmentApril 29, 2015

DrugsStilnox

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: FERRER INTERNACIONAL, S.A.
Enrollment: 130
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 29, 2015

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

FERRER INTERNACIONAL, S.A.

Eligibility Criteria

Inclusion Criteria

•To be randomly assigned to treatment in the study, patients must:
•Sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions
•Males and females aged 18 to 64 years old.
•Patients with insomnia disorder defined by the DSM \-5 (Diagnostic and Statistical Manual of Mental Disorders).
•Patients who reported at least 1 hour (60 minutes) of wakefulness after sleep onset and at least 30 minutes to fall asleep at least three (3\) nights a week over at least 4 weeks before the study starts confirmed by a 7 day sleep diary.
•BMI \= 18 kg/m2 and \= 32 kg/m2
•Be in good health as determined by their medical and sleep history, and results of physical examination, electrocardiogram (ECG), vital sign measurements, serum biochemistry, hematology, and urinalysis. A patient with a clinical abnormality may be included only if the investigator considers that the abnormality will not introduce additional health risk for the patient or interfere with study objectives
•Be at least 1 year postmenopausal for women older than 50 or be at least 2 years postmenopausal for women 50 or younger, or surgically sterile, or practicing an effective method of birth control (e.g. intrauterine device, or diaphragm with spermicide; or double barrier method) during the study and one month thereafter, if female. Contraceptives that induce CYP450 are not allowed.
•Be able to abstain from xanthine\-containing beverages (e.g., coffee, tea, coca\-cola) after 12\.00 (noon) on study visit days and refrain from intensive physical activities on study visit days
•Meet the following criteria as determined by the 7\-day Screening Sleep Diary:

Exclusion Criteria

•To be randomly assigned to treatment in the study, patients must NOT:
•Patients with any DSM\-5 psychiatric disorder (especially anxiety and post\-traumatic stress disorders) or any other sleep disorder including primary hypersomnia, narcolepsy, breathing\-related sleep disorder, circadian rhythm disorder or parasomnia within 6 months before or during this study
•Patients who have any undelaying disease for which it is known it interferes with sleep (painful syndromes etc.)
•Patient with sleep abnormalities like sleep apnea –AHI more than 10 episodes/hour and/or periodic leg movement syndrome with arousal/restless syndrome\- PLMAI more than 10 episodes/hour.
•Any over the counter or prescription sleep medication, medication with central effects, known properties which affect sleep/wake function or known to induce or inhibit the CYP3A4s, administered in a period equal to 5 half\-lives prior to the screening or required to be administered during the period of the trial.
•Patients with a known hypersensitivity to Lorediplon, Zolpidem or other drugs of the same class or other of any of the inactive ingredients.
•Evidence of any known clinically significant disease, including known or suspected human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.
•Any medical condition that in the investigators opinion may interfere with the study procedures and/or evaluations
•Lab. values, such as hemoglobin \=12 g/dL (120 g/L) for male subjects or \=10 g/dL (100 g/L) for female subjects. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \=2 x ULN and any other abnormal value considered clinically significant by the investigator.
•Patients with a history of substance abuse, substance dependence or lifestyle that precludes the diagnosis of insomnia disorder