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DB RCT for Specialized Phototherapy in Parkinson's Disease.

NCT ID: NCT04453033

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-26

Study Completion Date

2026-08-30

Brief Summary

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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.

Detailed Description

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Six month double blind, randomized controlled study with virtual clinic visits at baseline, week 13 and week 26. The Celeste specialized phototherapy device is similar to a tablet with a stand that allows the device to be angled towards the participant's face. The light is to be used each evening in the home for 1 hour, while the participant watches TV, eats dinner, reads, etc. The primary outcome measure is the Parkinson's Disease Questionnaire-39 Summary Index (PDQ-39SI). The PDQ-39 is a patient-reported, quality of life scale. The key secondary endpoint is Parts 1 and 2 of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS Parts 1 and 2 measure non-motor and motor function in Parkinson's. Participants will be assessed via online videoconferences.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Investigational Device

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.

Group Type ACTIVE_COMPARATOR

Celeste Specialized Phototherapy Device

Intervention Type DEVICE

Ocular phototherapy light panel

Control Device

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.

Group Type SHAM_COMPARATOR

Celeste Specialized Phototherapy Device

Intervention Type DEVICE

Ocular phototherapy light panel

Interventions

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Celeste Specialized Phototherapy Device

Ocular phototherapy light panel

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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 -

Exclusion Criteria

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

\-
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rochester

OTHER

Sponsor Role collaborator

PhotoPharmics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ray Dorsey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CT-2401

Identifier Type: -

Identifier Source: org_study_id