DB RCT for Specialized Phototherapy in Parkinson's Disease.

NCT04453033 | Active Not Recruiting FDA Device

• 1 other identifier: CT-2401
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pivotal study to determine whether light therapy can improve non-motor and motor function in Parkinson's disease, on top of current best medical treatment.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Parkinson's Disease Questionnaire-39 (PDQ-39)

  The Parkinson's Disease Questionnaire-39 (PDQ-39) is a patient-reported rating scale for quality of life in Parkinson's disease. Respondents affirm if they have experienced problems due to their disease using a five point scale from never (0 points) to always (4 points, or worse) in doing common activities. The PDQ-39 is comprised of 8 domains: mobility, emotion, activities of daily living, cognition, stigma, social support, communication, bodily discomfort. Total possible range of scores = 0 - 156, with higher scores representing worse severity.

  26 weeks

Secondary Outcomes (1)

• Movement Disorders Society-Unified Parkinson's Disease Rating Scale, Sum or Parts 1+2

  26 weeks

Other Outcomes (9)

• Parkinson's Disease Health Index (PD-HI)

  26 weeks

• Epworth Sleepiness Scale (ESS)

  26 weeks

• Scales for Outcomes in Parkinson's Disease - Sleep (SCOPA-Sleep)

  26 weeks

Study Arms (2)

Investigational Device

ACTIVE COMPARATOR

The Celeste device resembles a large tablet. It has a protective cover that folds into a stand and is magnetically attached to the back of the device. It produces a low intensity of specific bandwidths of light believed to be responsible for circadian and alerting responses in humans. The overall emission produces a pleasing soft glow of light.

Device: Celeste Specialized Phototherapy Device

Control Device

SHAM COMPARATOR

The Control device is identical in appearance to Celeste. When turned on, the device emits a soft diffused light that is indistinguishable in color from the Active Device. However, this device produces a different amount of the specific wavelengths thought to be effective in the Active Device. It is impossible to tell the difference between the sham device and the active device by looking at them.

Device: Celeste Specialized Phototherapy Device

Interventions

Celeste Specialized Phototherapy Device DEVICE

Ocular phototherapy light panel

Control Device; Investigational Device

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Parkinson's disease as determined by the study PI, in keeping with the UK PD Society Brain Bank Criteria for the Diagnosis of PD
• Responsiveness to dopaminergic medication, as judged by the rater, and have been using treatment for at least the past 1 year
• Relatively good eyesight as attested to by participants (Corrective lenses of at least 20/60)
• Stable levodopa and other anti-PD medications for at least 28 days prior to screening -

You may not qualify if:

• Diagnosis of an atypical Parkinsonian syndrome
• Significant OFF state or bothersome dyskinesias that in the judgment of the rater, would interfere with participation in the study.
• An anticipated need for a change in dopamine replacement therapy, concomitant medications, OTC/supplements, or other alternative therapies during the participant's involvement in the investigation
• History of previous light therapy use for PD

Sponsors & Collaborators

• PhotoPharmics, Inc.: lead
• University of Rochester: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ray Dorsey, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research suggests that certain wavelengths of light are more effective in treating Parkinson's, which means this therapeutic light device does not need to be nearly as bright as traditional light therapy. This study will test a light therapy device (Celeste® specialized light therapy device). We are testing two devices in this study: an active device which has these special wavelengths, and a control device which does not have the special wavelengths. Both lights look the same, and it is not possible to tell which light has the effective wavelength by looking at it. No one involved in the study (patients, families, doctors, investigative staff) knows which type of light therapy each person receives. A Device Technician, separate from the trial, will assist the participants in the device setup. Participants will be instructed not to disclose any aspects of their device. All study staff will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a six-month, randomized, double-blind, controlled, parallel group study with visits at screening, baseline, weeks 13 and 26, and blinded coordinator calls throughout the study for safety and efficacy assessments. This study will use a remote trial design, which will allow participants to be recruited nationally and evaluated centrally using video conferencing. All study participants will have their eligibility assessed and confirmed by a study coordinator and a PD specialist (primary investigator). Participants will complete the secondary outcome measures, which are Patient Response Outcomes (PRO's), and will be assisted by a blinded coordinator to ensure completeness of answers. A blinded rater will conduct the Primary Outcome Measure as well as the MDS-UPDRS. All assessments will be conducted by video at Baseline, Week 13, and Week 26 visits.

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 1, 2020
• Study Start: February 26, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)