Efficacy and Safety of Circadin for Non-24 Hour Sleep-Wake Disorder in Totally Blind Subjects

NCT00972075 | Completed Phase 2

• 1 other identifier: CIRCADIN 1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this placebo-controlled randomized study was to evaluate the efficacy of Circadin™ 2 mg in improving total night sleep duration and stabilizing the circadian clock phase in totally blind subjects with non-24 hour sleep-wake disorder.

Conditions

Non-24 Hour Sleep-Wake Disorder; Blindness

Keywords

totally blind subjects

Outcome Measures

Primary Outcomes (1)

• Total sleep time

  six weeks

Secondary Outcomes (1)

• Daily diary records of sleep latency, sleep maintenance , total duration of naps;

  six weeks

Study Arms (2)

Circadin

EXPERIMENTAL

Circadin is 2 mg of prolonged release melatonin

Drug: melatonin (Circadin)

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

melatonin (Circadin) DRUG

2 mg prolonged release melatonin tablets once daily 2 hours before going to bed

Also known as: Circadin, ATC code N05CH01

Circadin

placebo DRUG

one tablet per day 2 hours before going to bed

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 20-80, having no conscious perception of light.
• Meeting the criteria for diagnosing Non-24h cycle in the clinical setting: 1) difficulty initiating sleep or difficulty in awakening, 2) progressive delay of sleep phase with inability to maintain entrainment to 24-hour-day, and 3) presence of the sleep pattern for at least six weeks.
• Average total night sleep duration of less than 6 hours per night for at least six weeks.
• Ability to ingest oral medication and participate in all scheduled evaluations.
• Signing of the Informed Consent approved by the Ethics Committee. The Informed Consent will be written in both Braille and black-and-white forms for blind subject and sighted witness.
• Education or a work history sufficient to exclude mental retardation.
• Stable medications for non-excluded concurrent medical conditions for four weeks prior to the screening visit.

You may not qualify if:

• Presence of medical disorders other than those related to blindness and medical treatment that may influence melatonin production, sleep or alertness. To be ascertained by medical history, complete physical examination including ECG and general biochemical work-up including complete blood count, serum chemistries, and urine analysis.
• Presence of a psychiatric or mental disorder to be assessed by a structured psychiatric interview performed by a trained individual.
• History of seizure disorders.
• Irregular lifestyle or life pattern (e.g. shift workers and patients unable to keep the study routine).
• Presence of a sleep problem revealed that may explain the subjects' complaints, such as sleep disordered breathing, restless leg syndrome or periodic limb movement syndrome.
• Use of benzodiazepines or other hypnotics during the study and preceding two weeks or 5 half lives whichever is longer.
• Known or suspected hypersensitivity to exogenous melatonin or melatonin receptor agonists
• Use of melatonin during preceding two weeks
• Use of psychiatric medications during the study and preceding three months.
• History of autoimmune diseases
• Pharmacological immuno-suppression.
• Pregnancy or lactation, child-bearing potential with a lack of adequate contraception.
• History of severe pathology likely to recur during or immediately after the study.
• Participation in a clinical trial with any investigational agent within two months prior to study enrollment.
• Patients incapable of performing the daily call to the study IVRS system and reporting on the questionnaires.

Sponsors & Collaborators

• Neurim Pharmaceuticals Ltd.: lead

Study Sites (2)

Sleep Disorders Center of Atlanta

Atlanta, Georgia, 30382, United States

Location

Clinlabs, Inc.

New York, New York, 10019, United States

Location

Related Publications (1)

• Roth T, Nir T, Zisapel N. Prolonged release melatonin for improving sleep in totally blind subjects: a pilot placebo-controlled multicenter trial. Nat Sci Sleep. 2015 Jan 29;7:13-23. doi: 10.2147/NSS.S71838. eCollection 2015.

  PMID: 25678831 DERIVED

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Blindness

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Alan Lankford, PhD

  Sleep Disorders Center of Atlanta

  PRINCIPAL INVESTIGATOR

• Gary Zammit, PhD

  Clinlabs, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 4, 2009
• Study Start: February 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: October 1, 2007
• Last Updated: September 9, 2009

Record last verified: 2009-09

Locations

US (2)