Efficacy and Safety of KI1001 in ≥ 55 Years Old Insomnia Patients

NCT ID: NCT01450228

Last Updated: 2012-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-03-31

Brief Summary

KI1001(Circadin®, Prolonged release tablet which contains melatonin) has showed its efficacy to improve sleep quality in over 55 years old primary insomnia patients. This is a bridging study to investigate the efficacy and safety of KI1001(Circadin®) in Korean patients.

Detailed Description

Studies throughout the world have shown that insomnia is a common complaint that occurs in 10-50% of the population depending on age, sex and country. Among the wide variety of available treatments of sleep disturbances, the most commonly prescribed hypnotics are the benzodiazepines (BZD) and non-BZD hypnotics.

However, these hypnotics were often associated with rebound, dependency, tolerance, higher risk of falls mainly in the elderly population, anterograde memory disturbances and increased risk for motor accidents the next day.

In response to the unmet clinical need for a safe and efficacious alternative treatment for primary insomnia, that in addition to treating quantitative sleep problems, would improve sleep quality and daytime functioning, a clinical development program on melatonin for the treatment of primary insomnia was initiated.

This study is conducted using a randomised, double-blind, placebo controlled parallel group design, after a single-blind placebo period. Primary insomnia patients aged over 55 will be screened for entry into the study.

After placebo run-in period, Patients will enter a 3 weeks double-blind treatment period.

Primary parameter is quality of sleep, secondary parameters are including getting to sleep, awakening from sleep, behavior following wakefulness, quality of day and night, sleep latency and quality of life.

Conditions

Sleep Initiation and Maintenance Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo KI1001

Group Type: PLACEBO_COMPARATOR

Placebo KI1001

Intervention Type: DRUG

Placebo KI1001 tablets

KI1001

Group Type: EXPERIMENTAL

KI1001

Intervention Type: DRUG

Prolonged release melatonin 2mg

Interventions

KI1001

Prolonged release melatonin 2mg

Intervention Type: DRUG

Placebo KI1001

Placebo KI1001 tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female and aged ≥55 years
• Suffering from primary insomnia according to DSM-IV criteria and for whom this is the consultation complaint
• Good anticipated compliance
• Written informed consent to participate in the study given by the patient voluntarily
• Confirmed diagnosis of primary insomnia by sleep history questionnaire
• Established baseline pathology
• A good compliance during the two-weeks placebo run-in period defined as 70% to 130% of prescribed tablets
• Correct use of the Sleep Diary and of the LSEQ

Exclusion Criteria

• According to DSM-IV, subjects belonging to the following groups are excluded : 780.59(breathing related sleep disorder); 307.45(circadian thyrhm sleep disorder); 307.47(dyssomnia not otherwise specified); 780.XX(sleep disorder due to a general medical condition)
• Known or suspected hypersensitivity to exogenous melatonin or melatonin receptor agonists
• Known positive serology for human immunodeficiency virus (HIV) I antibodies or HIV II antibodies
• Known chronic active viral hepatitis
• Drug abuse or history or drug abuse(including alcohol)
• History of severe pathology likely to recur during or immediately after the study
• History of severe cardiac disorders
• History of severe neurological disorders or cerebral neurosurgery
• History of severe psychiatric disorders, especially psychosis and depression, sismotherapy
• depression will be assessed by the Raskin scale : a patient with a total score ≥ 6 will not be included
• anxiety will be assessed by the Covi scale : a patient with a total score ≥ 6 will not be included
• dementia will be assessed with the Mini Mental State (MMS) : a patient with a score ≤ 24 or 26 (depending on the socio-educational level of the patient) will not be included
• Neuro-psychiatric pathologies that might interfere with insomnia, patient assessment or study medication
• Use of psychotropic treatments for the past 3 months and during the study
• Use of benzodiazepines or other hypnotics during preceding two weeks (including all benzodiazepines; zopiclone, zolpidem, zaleplon, barbiturates, buspirone and hydroxyzine)
• All hypnotics or treatments used as an hypnotic are not allowed during the study
• Severe pain likely to interfere with sleep
• Other sleep disorders according to DSM-IV criteria identified by numerical ICD 9 code: breathing-related sleep disorder (780.59), circadian rhythm sleep disorder (307.45), dyssomnia not otherwise specified (307.47) and other sleep disorders (780.xx)
• Serious diseases that could interfere with patient assessment
• Organic pathologies which have not stabilised and that might interfere with sleep, patient assessment or study medication
• Intercurrent acute or chronic somatic diseases likely to interact with sleep (for example: chronic pain from any aetiology, benign prostatic hypertrophy likely to require surgery in the coming six months)
• Any concomitant documented progressive disease likely to interfere with the conduct of the study
• Any medical condition which might interfere with the completion of the study, or which would be adversely affected and thereby increasing the risk for the patient or interfering with patient assessments.
• Patients with an excessive consumption of alcohol, coffee or tea
• Patients with an irregular lifestyle or life pattern (e.g. shift workers and patients likely to be jet lagged)
• Patients with a Body Mass Index above 30 - obesity
• Patients who have taken any investigational drug within two months preceding the first dose of the study drug. Investigational drug is defined as any drug for which a marketing authorisation has not been granted in the country where the study was conducted.
• Patients receiving concomitant treatment which are not permitted
• A positive drug screen (benzodiazepines and opiates) during the initial two week placebo run-in period

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurim Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: collaborator

Kuhnil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin-Sang Yoon, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Jung-Hie Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

KangWon National University Hospital

Seung-Chul Hong, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea, St. Vincent Hospital

Doo-Heum Park, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Won-Chul Shin, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kyung Hee University Hospital at Gangdong

In-Young Yoon, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Kyu-In Jung, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Catholic University of Korea Saint Paul's Hospital

Yong-Won Cho, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Keimyung University Dongsan Medical Center

Jee-Hyun Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Dankook University

Seock-Hoon Chung, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Ulsan College of Medicine, Asan Medical Center

Locations

Dankook University Hospital

Cheonan, Chungcheongnam, South Korea

Keimyung University, Dongsan Medical Center

Daegu, Daegu, South Korea

Kangwon National University Hospital

Chuncheon, Gangwon-do, South Korea

Chonnam National University Hospital

Gwangju, Gwangju, South Korea

Seoul National University Bundang Hospital

Sungnam, Gyeonggi-do, South Korea

St. Vincent Hospital

Suwon, Gyeonggi-do, South Korea

St. Paul's Hospital

Seoul, Seoul, South Korea

Kyung Hee University Hospital at Gangdong

Seoul, Seoul, South Korea

Asan Medical Center

Seoul, Seoul, South Korea

Konkuk University Medical Center

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

10-CC-8302

Identifier Type: -

Identifier Source: org_study_id