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Study Title
Double-blind, randomized controlled trial to demonstrate the efficacy of Celeste® specialized phototherapy for the treatment of Parkinson disease (PD).
(ClinicalTrial.gov Identifier: NCT04453033)
Sponsor
PhotoPharmics, Inc.
Study Contact
Dan Adams (801-494-7804; [email protected])
Study Description and Design
Quadruple-masked, parallel-group study with an estimated 300 enrollments with a start date of February 26, 2024 and estimated study completion of March 2026. Participants will be randomly assigned to receive either Celeste specialized light therapy device or control device with no special wavelengths for 1 hour every night for 6 months. Participants will be assessed via online video conferences at baseline, week 13, and week 26.
Inclusion criteria
- Diagnosis of PD
- Responsive to dopaminergic medication, judged by the rater, and been using treatment for at least 1 year
- Eyesight is considered good by participants (corrective lenses minimum of 20/60)
- Stable levodopa and PD medications for at least 28 days before screening
Exclusion criteria
- Diagnosis of atypical Parkinson syndrome
- Significant OFF state or bothersome dyskinesias that the rater thinks would interfere with participation
- Expected change in dopamine replacement therapy, other medications, over-the-counter/supplements, or other alternative therapies during participant’s involvement
- Previous light therapy use for PD
Primary Outcomes
The primary outcome is measuring participants’ quality of life based off of the Parkinson’s Disease Questionnaire-39.
Secondary Outcomes
The secondary outcome is measuring the participants’ motor impact based off of the Movement Disorders Society-Unified Parkinson’s Disease Rating Scale using parts 1 and 2.
Locations Recruiting in the US
University of Rochester
- Rochester, NY
- Christi ALessi-Fox, MS: 585-275-3507; [email protected]
- Karen Clark, BS: 585-275-3507; [email protected]
Study Duration
February 26, 2024 through March 30, 2026