Overview

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

Status:
Completed
Trial end date:
2007-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Neurim Pharmaceuticals Ltd.
Treatments:
Melatonin
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.