Non-24 Hour Sleep-Wake DisorderPhase 2NCT00972075
Efficacy and Safety of Circadin for Non-24 Hour Sleep-Wake Disorder in Totally Blind Subjects
A Phase 2 study testing melatonin (Circadin) in people with Non-24 Hour Sleep-Wake Disorder and Blindness, run by Neurim Pharmaceuticals Ltd. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Non-24 Hour Sleep-Wake Disorder, Blindness
- What is being tested?
- melatonin (Circadin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2006to Oct 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sleep Disorders Center of Atlanta
Atlanta, Georgia, 30382
Clinlabs, Inc.
New York, New York, 10019
About this study
Official title: A Double-Blind, Placebo-Controlled Study of Circadin™ for Non-24 Hour Sleep-Wake Disorder in Totally Blind Subjects
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.
Read the detailed description
This was a multi-center, double-blind, placebo-controlled study of a once-daily (QD) dose of Circadin™ 2 mg in subjects with non-24 hour sleep-wake disorder. Subjects were initially treated with placebo for 2 weeks and then were randomly assigned in a 1:1 ratio to receive Circadin™ 2 mg or placebo for 6 weeks, followed by a 2-week washout period. The primary objective was to assess the effect of Circadin 2 mg given once daily for 6 weeks on total night sleep duration. Secondary objectives were other sleep variables recorded by the diary like sleep latency, daytime naps and sleep offset time. Other endpoints were CGIC score for Severity of Illness and Global Improvement and WHO (Five) Well-Being Index score.
- Conditions
- Non-24 Hour Sleep-Wake Disorder, Blindness
- Being tested
- melatonin (Circadin), placebo
- Keywords
- totally blind subjects
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatonin (Circadin)Drug
Also called Circadin, ATC code N05CH01
2 mg prolonged release melatonin tablets once daily 2 hours before going to bed
placeboDrug
one tablet per day 2 hours before going to bed
| Study group | Role | What they receive |
|---|---|---|
| Circadin | Experimental | Circadin is 2 mg of prolonged release melatonin Receives: Drug: melatonin (Circadin) |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time
Measured: six weeks
Secondary outcomes (1)
Daily diary records of sleep latency, sleep maintenance , total duration of naps;
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startFeb 2006
- Primary completionAug 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-24 Hour Sleep-Wake DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurim Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alan Lankford, PhD, Principal investigator, Sleep Disorders Center of AtlantaGary Zammit, PhD, Principal investigator, Clinlabs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972075
- Sponsor's protocol ID
- CIRCADIN 1
- Status last verified
- Sep 2009
- First submitted
- 3 Sep 2009
- Last updated
- 9 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25678831
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of Circadin™ for Non-24 Hour Sleep-Wake Disorder in Totally Blind Subjects
- ClinicalTrials.gov ID
- NCT00972075
- Acronym / sponsor ID
- CIRCADIN 1
- Conditions
- Non-24 Hour Sleep-Wake Disorder, Blindness
- Keywords
- totally blind subjects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Neurim Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a multi-center, double-blind, placebo-controlled study of a once-daily (QD) dose of Circadin™ 2 mg in subjects with non-24 hour sleep-wake disorder. Subjects were initially treated with placebo for 2 weeks and then were randomly assigned in a 1:1 ratio to receive Circadin™ 2 mg or placebo for 6 weeks, followed by a 2-week washout period. The primary objective was to assess the effect of Circadin 2 mg given once daily for 6 weeks on total night sleep duration. Secondary objectives were other sleep variables recorded by the diary like sleep latency, daytime naps and sleep offset time. Other endpoints were CGIC score for Severity of Illness and Global Improvement and WHO (Five) Well-Being Index score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circadin | Experimental | Drug: melatonin (Circadin)Circadin is 2 mg of prolonged release melatonin |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melatonin (Circadin)Also: Circadin, ATC code N05CH012 mg prolonged release melatonin tablets once daily 2 hours before going to bed | Drug | Circadin |
| placeboone tablet per day 2 hours before going to bed | Drug | Placebo |
Primary outcome
Total sleep time
Time frame: six weeks
1 secondary outcome
Daily diary records of sleep latency, sleep maintenance , total duration of naps;
Time frame: six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2009.
- Derived from this study: PubMed 25678831Roth 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Lankford, PhD principal investigator
Sleep Disorders Center of Atlanta
Gary Zammit, PhD principal investigator
Clinlabs, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing melatonin (Circadin) in people with Non-24 Hour Sleep-Wake Disorder and Blindness, run by Neurim Pharmaceuticals Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep time (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00972075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2009.