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

NCT01450228 | Completed Phase 3

• 1 other identifier: 10-CC-8302
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 10

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.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

primary insomnia

Outcome Measures

Primary Outcomes (1)

• QOS in LSEQ

  LSEQ - Leeds Sleep Evaluation Questionnaire QOS - Quality of Sleep

  three weeks

Secondary Outcomes (7)

• GTS in LSEQ

  three weeks

• QOD

  three weeks

• WHO 5-welling index

  three weeks

• PSQI

  three weeks

• AFS in LSEQ

  three weeks

Study Arms (2)

Placebo KI1001

PLACEBO COMPARATOR

Drug: Placebo KI1001

KI1001

EXPERIMENTAL

Drug: KI1001

Interventions

KI1001 DRUG

Prolonged release melatonin 2mg

KI1001

Placebo KI1001 DRUG

Placebo KI1001 tablets

Placebo KI1001

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kuhnil Pharmaceutical Co., Ltd.: lead
• Neurim Pharmaceuticals Ltd.: collaborator

Study Sites (10)

Dankook University Hospital

Cheonan, Chungcheongnam, 330-715, South Korea

Location

Keimyung University, Dongsan Medical Center

Daegu, Daegu, 700-712, South Korea

Location

Kangwon National University Hospital

Chuncheon, Gangwon-do, 200-722, South Korea

Location

Chonnam National University Hospital

Gwangju, Gwangju, 501-757, South Korea

Location

Seoul National University Bundang Hospital

Sungnam, Gyeonggi-do, 463-707, South Korea

Location

St. Vincent Hospital

Suwon, Gyeonggi-do, 442-723, South Korea

Location

St. Paul's Hospital

Seoul, Seoul, 130-709, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, Seoul, 134-727, South Korea

Location

Asan Medical Center

Seoul, Seoul, 138-736, South Korea

Location

Konkuk University Medical Center

Seoul, Seoul, 143-729, South Korea

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 12, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

KR (10)