Clinical Trial: Specialized Phototherapy in Parkinson Disease (LIGHT-PD)

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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

Study Duration

February 26, 2024 through March 30, 2026