Developmental Delay DisordersPhase 1NCT00506259
Treatment Strategies for Children With Smith-Magenis Syndrome
A Phase 1 study testing dTR Melatonin (NIH CC PDS), Phototherapy (Bright Light) and Melatonin CR in people with Developmental Delay Disorders and Chromosome Deletion, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
This study will examine the effect of bright light or melatonin treatment on sleep in children with Smith-Magenis syndrome (SMS), a genetic disorder characterized by certain physical, behavioral and developmental features. Read more about this study
- Who is it for?
- Ages 3 to 45 years
- Conditions the study is for
- Developmental Delay Disorders, Chromosome Deletion, Mental Retardation
- What is being tested?
- dTR Melatonin (NIH CC PDS), Phototherapy (Bright Light) and Melatonin CR
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2007to 22 May 2018
- Phase
- Phase 1
- 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 3 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- SMS subjects enrolled in protocol 01-HG-0109 will be invited to participate in this study. Protocol 01-HG-0109 has approximately 90 SMS subjects.
- SMS inpatient admissions for the dTR-MT trial will be deferred until the BL study completes 10 SMS subjects who demonstrate expected SMS inverted diurnal MT profiles at baseline (T0).
- SMS Subjects (N=12-15 per each treatment goal; 60 total enrollment):
- Male and female, childhood (average 5-16 years old; under age 5 years on case-by-case basis), all ethnicities with confirmed diagnosis of SMS (del 17p11.2). In some cases, molecular cytogenetic FISH screening (RAI1 FISH probe) may be required to confirm the SMS diagnosis prior to enrollment.
- Prepubertal (less than or equal to Tanner stage II).
- No history of seizures
Show all 15Show fewer
- Priority will be given to subjects who are medication free and/or willing to discontinue sleep/behavioral medications during the study trial. We anticipate significant interest from families whose children are currently enrolled in the 01-HG-0109 protocol. We will also consider drug-free new referrals (self-referrals and/or via health care providers) eligible for enrollment.
- Documented sleep disturbance (by sleep log diary and/or actigraphy).
- Unaffected Healthy Control Subjects (N=15). The pharmacokinetics of melatonin release by the dTR tablet will be evaluated in unaffected healthy control subjects prior to use in the inpatient SMS trial.
- Males and females of any ethnicity and between the ages 18-45 years.
- Regular (11PM - 7AM) sleep schedule for at least 1 week prior to study.
- Non-smokers, who have no history of seizures.
- Willing to discontinue coffee consumption for a period of 1-2 weeks prior to trial.
- BMI within normal limits (10-90 percentile).
- Unaffected with SMS.
Who cannot join
- SMS Subjects:
- Inability to obtain informed consent.
- Failure to confirm clinical diagnosis of SMS by standard molecular cytogenetic (FISH) methods and/or DNA-based mutation analysis of RAI1 gene.
- Retinal diseases: macular degeneration, retinitis pigmentosa, diabetes, cataracts.
- Skin disease: Lupus (lupus erythematosis), history of skin cancer, history of adverse reaction(s) to sun (rash, reddening).
- Medications that are photosensitizing: Phenothiazines (Thorazine, Stelazine), Imipramine (AD), Porphyrins (antitumor), Chloroquine (antimalarial), Hydrocholorthiazine (antihypertensive, diuretic), Lithium (mood stabilizer) and/or antibiotics (Tetracycline).
Show all 16Show fewer
- SMS subjects with extensive medication use may be excluded, depending on medications used and whether or not discontinuing medications for the trial presents a significant health risk. These include medications that might affect daytime vigilance (e.g., some seratonin antagonists such as Trazadone, SSRIs) and/or MAOIs, and/or antipsychotics (Risperidone), and/or some SSRIs (e.g., fluvoxamine) that affect the metabolism of melatonin and/or are strong CYP1A2 inhibitors.
- Healthy Adult Controls:
- Individuals who have been diagnosed with a sleep disorder (e.g, restless legs, sleep apnea) known to impact sleep may be excluded at the discretion of the PI.
- Not willing to discontinue caffeine consumption (chocolate, coffee, tea) during study period.
- Persons with extensive medication use may be excluded, depending on medications used and whether or not discontinuing medications for the trial presents a significant health risk. These include medications that might affect daytime vigilance (e.g., some seratonin antagonists such as Trazadone, SSRIs) and/or MAOIs, and/or antipsychotics (Risperidone), and/or some SSRIs (e.g., fluvoxamine) that affect the metabolism of melatonin and/or are strong CYP1A2 inhibitors.
- Employed on a shift work schedule.
- Transmeridian travel within the last 2 weeks.
- Currently using melatonin.
- Women currently taking oral contraceptives (BCPs)
- Pregnant women and/or nursing mothers
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Phase One Treatment Trial of the Circadian Sleep Disturbance in Smith-Magenis Syndrome (SMS)
This study will examine the effect of bright light or melatonin treatment on sleep in children with Smith-Magenis syndrome (SMS), a genetic disorder characterized by certain physical, behavioral and developmental features. Patients have a disrupted sleep cycle involving early waking, frequent daytime napping and frequent nighttime awakenings. Melatonin is a hormone normally produced at night in healthy people. People with SMS produce high levels of melatonin during the daytime and very low levels at night. This may affect their behavior, mood, attention span and sleep patterns.
Healthy volunteers between 18 and 45 years of age and children with SMS who are between 3 and 16 years of age may be eligible for this study.
Read more
Healthy subjects are admitted to the NIH Clinical Center overnight. In the morning they take one dose of time-release melatonin and have blood and saliva samples collected hourly from 7:00 AM to 6:00 PM.
Children with SMS participate in a 2-part study, as follows:
Part 1 Inpatient Trial
Pre-trial at-home phase: During the month before NIH inpatient admission, participants do the following:
- Wear an actiwatch device or keep a daily sleep diary to monitor daytime alertness, mood shifts and sleep patterns.
- Complete a behavior assessment survey related to the child s behaviors and sleep patterns.
- Obtain frequent body temperature measurements.
- Collect several saliva samples over a 24-hour period.
NIH admission phase:
- Children are admitted to the NIH Clinical Center for 2-3 nights for bright light treatment. They remain in their rooms for alternating periods of exposure to standard dim room light and bright light, using a light box placed within 3 to 5 feet of the child. An electroencephalogram (EEG) with additional electrodes to track eye movements is used to monitor the child s attention. Between 8AM and 6PM serial blood samples are collected to measure melatonin levels. A parent rates the child s mood and behavior during the 2-day test period.
- Children are admitted to the NIH Clinical Center for 2-3 nights for melatonin treatment. They take a single dose of melatonin or placebo tablet at bedtime. During the daytime, EEG electrodes are placed to track eye movements. Between 7 PM and 7 AM serial blood samples are collected to measure melatonin levels. A parent rates the child s behavior and mood as described for the bright light study.
- Children may receive either or both of the bright light and melatonin treatments.
Part 2 Outpatient Trial
Children participate in a combined bright light with melatonin trial at home. They undergo the same procedures outlined in the pre-trial at-home phase of Part 1 (actiwatch, behavior assessments, body temperature measurements, saliva samples) over an 11-week period. If saliva samples cannot be collected for melatonin testing, 24-hour urine samples may be collected instead.
Read the detailed description
Smith-Magenis syndrome (SMS) is a rare (1/25,000) clinically recognizable syndrome, characterized by the following features: a distinct pattern of minor craniofacial and skeletal anomalies, expressive speech/language delays, psychomotor and growth retardation, and a striking neurobehavioral phenotype. This phenotype includes stereotypies, self-injurious and aggressive behaviors, and a chronic sleep disorder associated with an inverted circadian melatonin rhythm. Sleep disturbances include daytime sleepiness, early sleep onset, and early morning awakening. Disturbed sleep is the strongest predictor of maladaptive behavior in children with SMS. Diminished nocturnal sleep is virtually universal in SMS, representing a major challenge to the patient and family. The majority (greater than 95%) of cases are due to interstitial deletion of 17p11.2; however, rare cases due to RAI1 gene mutations are also reported.
One of the likely contributing factors to these sleep disturbances is an inverse circadian pattern of the sleep-promoting hormone, melatonin. In SMS, plasma melatonin is high during the day and low at night, which is opposite the normal pattern. The underlying reason for this regular daytime melatonin secretory pattern is unknown. To our knowledge this pattern is distinctive to persons with SMS and not found elsewhere. SMS therefore offers a unique human syndrome for the study of melatonin function. At the present time, there is no effective treatment for sleep disturbances in SMS. Moreover, there are currently no controlled treatment trials underway in the U.S. with the specific goal of correcting the disturbed sleep pattern observed in this disease.
The aim of this Phase 1 treatment trial is to improve the quality of nocturnal sleep and decrease the need for daytime sleep by restoring a normal circadian pattern of melatonin levels in children with Smith-Magenis syndrome (SMS). We predict that the inverse pattern of release can be corrected by the combination of non-pharmacological suppression of daytime melatonin release and pharmacological replacement of nocturnal melatonin. Negative behaviors associated with accumulated sleep debt are expected to diminish as sleep quality improves.
Two treatment modalities will be evaluated alone and in combination: 1) light-induced suppression of daytime melatonin release and delay of nighttime sleep; and 2) pharmacological replacement of nocturnal melatonin. Melatonin levels measured in blood (Pre- vs. Post-treatment) will serve as the primary outcome parameter. A dTR-melatonin tablet developed by the Clinical Center Pharmaceutical Development Services (CC-PDS) will be used in this trial.
- Conditions
- Developmental Delay Disorders, Chromosome Deletion, Mental Retardation, Sleep Disorders, Circadian Rhythm, Self Injurious Behavior
- Being tested
- dTR Melatonin (NIH CC PDS), Phototherapy (Bright Light), Melatonin CR
- Keywords
- Deletion 17p11.2, Melatonin, Phototherapy, Behavioral Phenotype, Developmental Delay/MR, Smith-Magenis Syndrome, Sleep Disturbance, SMS, Sleep Disorder
- Medical subject headings
- Developmental Disabilities, Chromosome Deletion, Intellectual Disability, Sleep Disorders, Circadian Rhythm, Self-Injurious Behavior, Smith-Magenis Syndrome, Parasomnias, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dTR Melatonin (NIH CC PDS)Drug
Phototherapy (Bright Light)Device
Melatonin CRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of melatonin (pg/ml) from baseline
Secondary outcomes (1)
Improved sleep parameters (actigraphy). Increased daytime vigilance. Decreased maladaptive behaviors.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study start17 Jul 2007
- Primary completion22 May 2018
- Study completion22 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Developmental Delay DisordersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- William A Gahl, M.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506259
- Sponsor's protocol ID
- 070076
- Other IDs
- 07-HG-0076
- Status last verified
- 22 May 2018
- First submitted
- 21 Jul 2007
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
Bi W, Saifi GM, Shaw CJ, Walz K, Fonseca P, Wilson M, Potocki L, Lupski JR. Mutations of RAI1, a PHD-containing protein, in nondeletion patients with Smith-Magenis syndrome. Hum Genet. 2004 Nov;115(6):515-24. doi: 10.1007/s00439-004-1187-6. Epub 2004 Sep 30.
PubMed 15565467Slager RE, Newton TL, Vlangos CN, Finucane B, Elsea SH. Mutations in RAI1 associated with Smith-Magenis syndrome. Nat Genet. 2003 Apr;33(4):466-8. doi: 10.1038/ng1126. Epub 2003 Mar 24.
PubMed 12652298De Leersnyder H, De Blois MC, Claustrat B, Romana S, Albrecht U, Von Kleist-Retzow JC, Delobel B, Viot G, Lyonnet S, Vekemans M, Munnich A. Inversion of the circadian rhythm of melatonin in the Smith-Magenis syndrome. J Pediatr. 2001 Jul;139(1):111-6. doi: 10.1067/mpd.2001.115018.
PubMed 11445803
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase One Treatment Trial of the Circadian Sleep Disturbance in Smith-Magenis Syndrome (SMS)
- ClinicalTrials.gov ID
- NCT00506259
- Acronym / sponsor ID
- 070076
- Conditions
- Developmental Delay Disorders, Chromosome Deletion, Mental Retardation, Sleep Disorders, Circadian Rhythm, Self Injurious Behavior
- Keywords
- Deletion 17p11.2, Melatonin, Phototherapy, Behavioral Phenotype, Developmental Delay/MR, Smith-Magenis Syndrome, Sleep Disturbance, SMS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 17 Jul 2007
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 25 Jul 2007 (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.
This study will examine the effect of bright light or melatonin treatment on sleep in children with Smith-Magenis syndrome (SMS), a genetic disorder characterized by certain physical, behavioral and developmental features. Patients have a disrupted sleep cycle involving early waking, frequent daytime napping and frequent nighttime awakenings. Melatonin is a hormone normally produced at night in healthy people. People with SMS produce high levels of melatonin during the daytime and very low levels at night. This may affect their behavior, mood, attention span and sleep patterns.
Healthy volunteers between 18 and 45 years of age and children with SMS who are between 3 and 16 years of age may be eligible for this study.
Healthy subjects are admitted to the NIH Clinical Center overnight. In the morning they take one dose of time-release melatonin and have blood and saliva samples collected hourly from 7:00 AM to 6:00 PM.
Children with SMS participate in a 2-part study, as follows:
Part 1 Inpatient Trial
Pre-trial at-home phase: During the month before NIH inpatient admission, participants do the following:
- Wear an actiwatch device or keep a daily sleep diary to monitor daytime alertness, mood shifts and sleep patterns.
- Complete a behavior assessment survey related to the child s behaviors and sleep patterns.
- Obtain frequent body temperature measurements.
- Collect several saliva samples over a 24-hour period.
NIH admission phase:
- Children are admitted to the NIH Clinical Center for 2-3 nights for bright light treatment. They remain in their rooms for alternating periods of exposure to standard dim room light and bright light, using a light box placed within 3 to 5 feet of the child. An electroencephalogram (EEG) with additional electrodes to track eye movements is used to monitor the child s attention. Between 8AM and 6PM serial blood samples are collected to measure melatonin levels. A parent rates the child s mood and behavior during the 2-day test period.
- Children are admitted to the NIH Clinical Center for 2-3 nights for melatonin treatment. They take a single dose of melatonin or placebo tablet at bedtime. During the daytime, EEG electrodes are placed to track eye movements. Between 7 PM and 7 AM serial blood samples are collected to measure melatonin levels. A parent rates the child s behavior and mood as described for the bright light study.
- Children may receive either or both of the bright light and melatonin treatments.
Part 2 Outpatient Trial
Children participate in a combined bright light with melatonin trial at home. They undergo the same procedures outlined in the pre-trial at-home phase of Part 1 (actiwatch, behavior assessments, body temperature measurements, saliva samples) over an 11-week period. If saliva samples cannot be collected for melatonin testing, 24-hour urine samples may be collected instead.
Detailed description
Smith-Magenis syndrome (SMS) is a rare (1/25,000) clinically recognizable syndrome, characterized by the following features: a distinct pattern of minor craniofacial and skeletal anomalies, expressive speech/language delays, psychomotor and growth retardation, and a striking neurobehavioral phenotype. This phenotype includes stereotypies, self-injurious and aggressive behaviors, and a chronic sleep disorder associated with an inverted circadian melatonin rhythm. Sleep disturbances include daytime sleepiness, early sleep onset, and early morning awakening. Disturbed sleep is the strongest predictor of maladaptive behavior in children with SMS. Diminished nocturnal sleep is virtually universal in SMS, representing a major challenge to the patient and family. The majority (greater than 95%) of cases are due to interstitial deletion of 17p11.2; however, rare cases due to RAI1 gene mutations are also reported.
One of the likely contributing factors to these sleep disturbances is an inverse circadian pattern of the sleep-promoting hormone, melatonin. In SMS, plasma melatonin is high during the day and low at night, which is opposite the normal pattern. The underlying reason for this regular daytime melatonin secretory pattern is unknown. To our knowledge this pattern is distinctive to persons with SMS and not found elsewhere. SMS therefore offers a unique human syndrome for the study of melatonin function. At the present time, there is no effective treatment for sleep disturbances in SMS. Moreover, there are currently no controlled treatment trials underway in the U.S. with the specific goal of correcting the disturbed sleep pattern observed in this disease.
The aim of this Phase 1 treatment trial is to improve the quality of nocturnal sleep and decrease the need for daytime sleep by restoring a normal circadian pattern of melatonin levels in children with Smith-Magenis syndrome (SMS). We predict that the inverse pattern of release can be corrected by the combination of non-pharmacological suppression of daytime melatonin release and pharmacological replacement of nocturnal melatonin. Negative behaviors associated with accumulated sleep debt are expected to diminish as sleep quality improves.
Two treatment modalities will be evaluated alone and in combination: 1) light-induced suppression of daytime melatonin release and delay of nighttime sleep; and 2) pharmacological replacement of nocturnal melatonin. Melatonin levels measured in blood (Pre- vs. Post-treatment) will serve as the primary outcome parameter. A dTR-melatonin tablet developed by the Clinical Center Pharmaceutical Development Services (CC-PDS) will be used in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
Who may qualify
- Ages
- 3 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- SMS subjects enrolled in protocol 01-HG-0109 will be invited to participate in this study. Protocol 01-HG-0109 has approximately 90 SMS subjects.
- SMS inpatient admissions for the dTR-MT trial will be deferred until the BL study completes 10 SMS subjects who demonstrate expected SMS inverted diurnal MT profiles at baseline (T0).
- Male and female, childhood (average 5-16 years old; under age 5 years on case-by-case basis), all ethnicities with confirmed diagnosis of SMS (del 17p11.2). In some cases, molecular cytogenetic FISH screening (RAI1 FISH probe) may be required to confirm the SMS diagnosis prior to enrollment.
- Prepubertal (less than or equal to Tanner stage II).
- No history of seizures
Key exclusion criteria (16 listed)
- Inability to obtain informed consent.
- Failure to confirm clinical diagnosis of SMS by standard molecular cytogenetic (FISH) methods and/or DNA-based mutation analysis of RAI1 gene.
- Retinal diseases: macular degeneration, retinitis pigmentosa, diabetes, cataracts.
- Skin disease: Lupus (lupus erythematosis), history of skin cancer, history of adverse reaction(s) to sun (rash, reddening).
- Medications that are photosensitizing: Phenothiazines (Thorazine, Stelazine), Imipramine (AD), Porphyrins (antitumor), Chloroquine (antimalarial), Hydrocholorthiazine (antihypertensive, diuretic), Lithium (mood stabilizer) and/or antibiotics (Tetracycline).
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 |
|---|---|---|
| dTR Melatonin (NIH CC PDS) | Drug | – |
| Phototherapy (Bright Light) | Device | – |
| Melatonin CR | Drug | – |
Primary outcome
Change in level of melatonin (pg/ml) from baseline
1 secondary outcome
Improved sleep parameters (actigraphy). Increased daytime vigilance. Decreased maladaptive behaviors.
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 12 Dec 2019.
- Background: PubMed 15565467Bi W, Saifi GM, Shaw CJ, Walz K, Fonseca P, Wilson M, Potocki L, Lupski JR. Mutations of RAI1, a PHD-containing protein, in nondeletion patients with Smith-Magenis syndrome. Hum Genet. 2004 Nov;115(6):515-24. doi: 10.1007/s00439-004-1187-6. Epub 2004 Sep 30.
- Background: PubMed 12652298Slager RE, Newton TL, Vlangos CN, Finucane B, Elsea SH. Mutations in RAI1 associated with Smith-Magenis syndrome. Nat Genet. 2003 Apr;33(4):466-8. doi: 10.1038/ng1126. Epub 2003 Mar 24.
- Background: PubMed 11445803De Leersnyder H, De Blois MC, Claustrat B, Romana S, Albrecht U, Von Kleist-Retzow JC, Delobel B, Viot G, Lyonnet S, Vekemans M, Munnich A. Inversion of the circadian rhythm of melatonin in the Smith-Magenis syndrome. J Pediatr. 2001 Jul;139(1):111-6. doi: 10.1067/mpd.2001.115018.
Related trials for Developmental Delay Disorders
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
William A Gahl, M.D. principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dTR Melatonin (NIH CC PDS), Phototherapy (Bright Light) and Melatonin CR in people with Developmental Delay Disorders and Chromosome Deletion, run by National Human Genome Research Institute (NHGRI) at 1 site 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 15 inclusion and 16 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 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in level of melatonin (pg/ml) from baseline. 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 NCT00506259, which also lists 3 linked publications.
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 12 Dec 2019.