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

This study has been completed.
Sponsor:
Collaborator:
Neurim Pharmaceuticals Ltd.
Information provided by (Responsible Party):
Kuhnil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01450228
First received: October 6, 2011
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Sleep Initiation and Maintenance Disorders
Drug: KI1001
Drug: Placebo KI1001
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Kuhnil Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • QOS in LSEQ [ Time Frame: three weeks ] [ Designated as safety issue: No ]
    LSEQ - Leeds Sleep Evaluation Questionnaire QOS - Quality of Sleep


Secondary Outcome Measures:
  • GTS in LSEQ [ Time Frame: three weeks ] [ Designated as safety issue: No ]
    LSEQ - Leeds Sleep Evaluation Questionnaire GTS - Getting to Sleep

  • QOD [ Time Frame: three weeks ] [ Designated as safety issue: No ]
    Quality of day in Patient Diary

  • WHO 5-welling index [ Time Frame: three weeks ] [ Designated as safety issue: No ]
  • PSQI [ Time Frame: three weeks ] [ Designated as safety issue: No ]
    Pittsburgh Sleep Quality Index

  • AFS in LSEQ [ Time Frame: three weeks ] [ Designated as safety issue: No ]
    LSEQ - Leeds Sleep Evaluation Questionnaire AFS - Awakening from Sleep

  • BFW in LSEQ [ Time Frame: three weeks ] [ Designated as safety issue: No ]
    LSEQ - Leeds Sleep Evaluation Questionnaire BFW - Behavior following Wakefulness

  • QON [ Time Frame: three weeks ] [ Designated as safety issue: No ]
    Quality of Night in Patient Diary


Enrollment: 170
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo KI1001 Drug: Placebo KI1001
Placebo KI1001 tablets
Experimental: KI1001 Drug: KI1001
Prolonged release melatonin 2mg

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450228

Locations
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
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Asan Medical Center
Seoul, Korea, Republic of, 138-736
St. Paul's Hospital
Seoul, Korea, Republic of, 130-709
Kyung Hee University Hospital at Gangdong
Seoul, Korea, Republic of, 134-727
Sponsors and Collaborators
Kuhnil Pharmaceutical Co., Ltd.
Neurim Pharmaceuticals Ltd.
Investigators
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 Gangdong Hospital
Principal Investigator: In-Young Yoon, M.D., Ph.D. Seoul National University Bundang Hospital
Principal Investigator: Kyu-In Jung, M.D., Ph.D. The Catholic University of Korea, St. 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
  More Information

No publications provided

Responsible Party: Kuhnil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01450228     History of Changes
Other Study ID Numbers: 10-CC-8302
Study First Received: October 6, 2011
Last Updated: April 23, 2012
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 20, 2014