Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Blind Child Melatonin Treatment Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Oregon Health and Science University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alfred Lewy, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00691444
First received: June 3, 2008
Last updated: November 4, 2014
Last verified: November 2014

June 3, 2008
November 4, 2014
September 2002
March 2015   (final data collection date for primary outcome measure)
circadian phase marker, as measured by the melatonin levels in serial salivary and/or plasma samples. [ Time Frame: biweekly throughout the entire study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00691444 on ClinicalTrials.gov Archive Site
Durability and Toxicity Side Effects Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Blind Child Melatonin Treatment Study
Melatonin Studies of Blind Children

The primary focus of this five-year study will be to optimize the melatonin dosing regimen for synchronizing the body clocks of blind children to the 24-hour day.

We intend to study as many as 26 blind children through up to three melatonin treatment regimens, all of which involve a dose step-down in which the melatonin dose will be reduced gradually to find the lowest effective dose. The 3 treatment plans differ only in the start dose. Successfully treated subjects (of one treatment plan) will enter a one-year intensive assessment of the safety and efficacy of melatonin treatment in which the subject will take the same dose for one year and complete biweekly assessments of efficacy and side-effects. The final phase of the study involves a placebo discontinuation, in which the subject's circadian rhythm will be returned to the baseline rhythm (this may take up to 6 months for some subjects).

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Blindness
  • Dietary Supplement: Melatonin

    Subjects will be given up to 0.5 mg daily.

    0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns).

  • Dietary Supplement: Melatonin

    Subjects will be given up to 10 mg daily.

    0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns).

  • Biological: Melatonin

    Subjects will be given up to 20 mg daily.

    0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns).

  • Experimental: 1
    Subjects will be given up to 0.5 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.
    Intervention: Dietary Supplement: Melatonin
  • Experimental: 2
    Subjects will be given up to 10 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.
    Intervention: Dietary Supplement: Melatonin
  • Experimental: 3
    Subjects will be given up to 20 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.
    Intervention: Biological: Melatonin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
26
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children and adults 5 to 20 years old
  • Blindness for at least one year, verified by an ophthalmologic exam
  • Ability to comply with the requirements of the experimental protocol
  • And no clinically significant abnormalities (other than blindness) on a general physical examination.
  • Subjects must be competent to sign informed consent if age 18 or older. Parents and subjects will be interviewed together and, when appropriate (for example, subject is age 18 or older), separately as well.

Exclusion Criteria:

  • Abnormal heart, liver or kidney function; intractable seizure disorders
  • Significant laboratory abnormalities on CBC, Comprehensive Metabolic set, or UA (dip stick method)
  • Pregnancy; sexual activity in post-pubertal females not using a recognized and valid contraceptive method
  • A current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual ; OR
  • External demands that limit the ability to maintain a regular schedule, e.g. night shift work.
Both
5 Years to 20 Years
No
Contact: Amber Laurie 1-866-424-6060 sleeplab@ohsu.edu
Contact: Alfred J Lewy, MD, PhD 503-494-7746 lewy@ohsu.edu
United States
 
NCT00691444
eIRB 1251, R01 HD42125
Yes
Alfred Lewy, Oregon Health and Science University
Oregon Health and Science University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Alfred J Lewy, MD, PhD Oregon Health and Science University
Oregon Health and Science University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP