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

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. Identifier: NCT01450228
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : April 24, 2012
Neurim Pharmaceuticals Ltd.
Information provided by (Responsible Party):
Kuhnil Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Drug: KI1001 Drug: Placebo KI1001 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Parallel Group, Randomised, Placebo Controlled, Multicenter, Bridging Phase III Study of Efficacy and Safety of KI1001 in the Improvement of Sleep Quality in ≥ 55 Years Old Insomnia Patients
Study Start Date : March 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Arm Intervention/treatment
Placebo Comparator: Placebo KI1001 Drug: Placebo KI1001
Placebo KI1001 tablets

Experimental: KI1001 Drug: KI1001
Prolonged release melatonin 2mg

Primary Outcome Measures :
  1. QOS in LSEQ [ Time Frame: three weeks ]
    LSEQ - Leeds Sleep Evaluation Questionnaire QOS - Quality of Sleep

Secondary Outcome Measures :
  1. GTS in LSEQ [ Time Frame: three weeks ]
    LSEQ - Leeds Sleep Evaluation Questionnaire GTS - Getting to Sleep

  2. QOD [ Time Frame: three weeks ]
    Quality of day in Patient Diary

  3. WHO 5-welling index [ Time Frame: three weeks ]
  4. PSQI [ Time Frame: three weeks ]
    Pittsburgh Sleep Quality Index

  5. AFS in LSEQ [ Time Frame: three weeks ]
    LSEQ - Leeds Sleep Evaluation Questionnaire AFS - Awakening from Sleep

  6. BFW in LSEQ [ Time Frame: three weeks ]
    LSEQ - Leeds Sleep Evaluation Questionnaire BFW - Behavior following Wakefulness

  7. QON [ Time Frame: three weeks ]
    Quality of Night in Patient Diary

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01450228

Korea, Republic of
Dankook University Hospital
Cheonan, Chungcheongnam, Korea, Republic of, 330-715
Seoul National University Bundang Hospital
Sungnam, Gyeonggi, Korea, Republic of, 463-707
St. Vincent Hospital
Suwon, Gyeonggi, Korea, Republic of, 442-723
Kangwon National University Hospital
Chuncheon, Kangwon, Korea, Republic of, 200-722
Keimyung University, Dongsan Medical Center
Daegu, Korea, Republic of, 700-712
Chonnam National University Hospital
Gwangju, Korea, Republic of, 501-757
St. Paul's Hospital
Seoul, Korea, Republic of, 130-709
Kyung Hee University Hospital at Gangdong
Seoul, Korea, Republic of, 134-727
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Sponsors and Collaborators
Kuhnil Pharmaceutical Co., Ltd.
Neurim Pharmaceuticals Ltd.
Principal Investigator: Jin-Sang Yoon, M.D., Ph.D. Chonnam National University Hospital
Principal Investigator: Jung-Hie Lee, M.D., Ph.D. KangWon National University Hospital
Principal Investigator: Seung-Chul Hong, M.D., Ph.D. The Catholic University of Korea, St. Vincent Hospital
Principal Investigator: Doo-Heum Park, M.D., Ph.D. Konkuk University Medical Center
Principal Investigator: Won-Chul Shin, M.D., Ph.D. Kyung Hee University Hospital at Gangdong
Principal Investigator: In-Young Yoon, M.D., Ph.D. Seoul National University Bundang Hospital
Principal Investigator: Kyu-In Jung, M.D., Ph.D. Catholic University of Korea Saint Paul's Hospital
Principal Investigator: Yong-Won Cho, M.D., Ph.D. Keimyung University Dongsan Medical Center
Principal Investigator: Jee-Hyun Kim, M.D., Ph.D. Dankook University
Principal Investigator: Seock-Hoon Chung, M.D., Ph.D. University of Ulsan College of Medicine, Asan Medical Center

Responsible Party: Kuhnil Pharmaceutical Co., Ltd. Identifier: NCT01450228     History of Changes
Other Study ID Numbers: 10-CC-8302
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: April 24, 2012
Last Verified: April 2012

Keywords provided by Kuhnil Pharmaceutical Co., Ltd.:
primary insomnia

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