Blind Child Melatonin Treatment Study

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Blindness

Clinical Trial Details

NCT number	NCT00691444
Study type	Interventional
Source	Oregon Health and Science University
Contact
Status	Terminated
Phase	N/A
Start date	September 2002
Completion date	December 2015

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02393118` - A Study to Evaluate the BrainPort Vision Device in Individuals Blinded by Traumatic Injury	N/A
Terminated	`NCT00262509` - Emergency Egress and Information System for Persons With Vision Loss	N/A
Recruiting	`NCT06237829` - Testing Tactile Aids With Blind Subjects	N/A
Completed	`NCT00829036` - Wayfinding Information Access System for People With Vision Loss	N/A
Completed	`NCT02643238` - Continued Study of Artificial Vision: Evaluation of the BrainPort® System and Investigation of Visual Ambulation	N/A
Completed	`NCT01488786` - A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind	N/A
Recruiting	`NCT00403143` - Do Blue-Blocking Lenses Block Blue Colour From Our Lives?	N/A
Recruiting	`NCT06451172` - Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis	Early Phase 1
Recruiting	`NCT04725760` - Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population	N/A
Recruiting	`NCT02983370` - Development of a Cortical Visual Neuroprosthesis for the Blind	N/A
Not yet recruiting	`NCT06070467` - Holistic Mixed Approaches to Capture the Real Life of Children With Rare Eye Diseases
Completed	`NCT01109576` - Workshops for Veterans With Vision and Hearing Loss	Phase 0
Completed	`NCT00920231` - Computer Vision System for the Blind Veteran	Phase 1
Terminated	`NCT00795236` - Melatonin Studies of Totally Blind Children	N/A
Terminated	`NCT00634972` - Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity	Phase 4
Enrolling by invitation	`NCT06364605` - MySpace: the Role of Vision in Representing Space	N/A
Terminated	`NCT03913130` - Extension Study to Study PQ-110-001 (NCT03140969)	Phase 1/Phase 2
Not yet recruiting	`NCT05806684` - Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
Completed	`NCT03753893` - Ocular Manifestations in Rheumatic Diseases
Recruiting	`NCT04855045` - An Open-label, Dose Escalation and Double-masked, Randomized, Controlled Trial Evaluating Safety and Tolerability of Sepofarsen in Children (<8 Years of Age) With LCA10 Caused by Mutations in the CEP290 Gene.	Phase 2/Phase 3