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DB RCT for Specialized Phototherapy in Parkinson's Disease. (LIGHT-PD)

Primary Purpose

Parkinson Disease

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Celeste Specialized Phototherapy Device

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

More than 50% of the waking day spent in the OFF state

More than 25% (>4 hours/day) of bothersome dyskinesias

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Investigational Device

Control Device

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

MDS-UPDRS Part 1: Non-motor impact of experiences of daily living. Part I has 13 questions, the first 6 are assessed by the examiner, and the remaining 7 are usually self assessed, but may include the patient's caregiver. Each question = 0-4, range= 0 - 65, with higher scores representing worse severity. MDS-UPDRS Part II: Motor Aspects of Experiences of Daily Living: This portion of the scale assesses the motor impact of PD on patients' experiences of daily living. There are 13 questions which are a component of the self-administered Patient Questionnaire. Each question = 0-4, range = 0-65. with higher scores representing worse severity.

Full Information

NCT ID

NCT04453033

First Posted

June 26, 2020

Last Updated

March 27, 2023

Sponsor

PhotoPharmics, Inc.

Collaborators

University of Rochester

1. Study Identification

Unique Protocol Identification Number

NCT04453033

Brief Title

DB RCT for Specialized Phototherapy in Parkinson's Disease.

Acronym

LIGHT-PD

Official Title

Double-blind, Randomized Controlled Trial to Demonstrate Efficacy of Celeste® Specialized Phototherapy in Treating Parkinson's Disease.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2023 (Anticipated)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PhotoPharmics, Inc.

Collaborators

University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The purpose of the study is to determine whether one intensity is more effective than other intensities of light, and it is unknown whether one intensity will be more effective. Thus, subjects will receive a study device which looks identical to the other devices and which produces the same bandwidths (color), but which may produce a different intensity of that color of light. 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. A separate Medical Monitor may become unmasked if the participants experience a serious adverse event that may be related to the therapy. However, this is unlikely, since the therapy is considered safe.

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Investigational Device

Arm Type

Active Comparator

Arm Description

Arm Title

Control Device

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Celeste Specialized Phototherapy Device

Intervention Description

Ocular phototherapy light panel

Primary Outcome Measure Information:

Title

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

Description

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

26 weeks

Other Pre-specified Outcome Measures:

Title

Epworth Sleepiness Scale (ESS)

Description

The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness to help in diagnosing sleep disorders. The ESS questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 (none) to 3 (worse) for eight different everyday situations. The total range is 0 - 24, with higher scores representing worse severity.

Time Frame

26 weeks

Title

Beck Depression Inventory -II (BDI-II)

Description

The Beck Depression Inventory (BDI) is a 21-question multiple choice inventory to measure the severity of depression. Each question is scored on a scale value of 0 to 3. The cutoffs used are: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. Higher total scores indicate more severe depressive symptoms.

Time Frame

26 weeks

Title

Beck Anxiety Scale (BAI)

Description

The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63). Input from a caregiver to the participant is acceptable.

Time Frame

26 weeks

Title

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

Description

The SCOPA-SLEEP is a frequency measure scale to assess the character and quantify the various aspects of sleep problems in Parkinson's disease. The SCOPA-Sleep consists of 13 items, including information about the use of sleeping tablets. Questions range from 0 to 4 in severity, (Question 7, Quality of Sleep, ranges from 0-7). A higher total score indicates more severe sleep problems.

Time Frame

26 weeks

Title

Cogstate Brief Battery (CBB)

Description

The CogState Brief Battery (CBB) is a brief, computer-administered cognitive test battery that consists of four cognitive tasks that measure psychomotor function, attention, working memory and memory. The administration, scoring and reporting is automated and highly standardized. Each task in the battery is constructed using playing cards as stimuli with the test taker required to answer only "yes" or "no" on each trial in accord with a simple rule. A higher score indicates better cognition. The CBB will be used at Baseline and again at Week 26. An efficacy analysis may be conducted at the end of the study.

Time Frame

26 weeks

Title

Fatigue Severity Scale (FSS)

Description

The Fatigue Severity Scale is a 9-item, self-report scale, which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Answers are scored on a seven-point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities. It is simple to understand and takes an average of eight minutes to answer

Time Frame

26 weeks

Title

Montreal Cognitive Assessment (MoCA)

Description

The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The MoCA will be used at screening, mainly for characterization purposes and to assist the site investigators in their decisions to include participants in the trial. Higher scores indicate better cognitive function, while a score below 26 may indicate mild cognitive impairment.

Time Frame

26 weeks

Title

Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part 3 (Modified)

Description

The MDS-UPDRS Part 3 is the motor examination section of the MDS-UPDRS. It is completed by the Evaluator. Part 3 evaluates speech, tremor, bradykinesia, rigidity, spontaneity of movement, gait, and balance. Because rigidity (3.3) and postural stability (3.12) cannot be measured remotely, a modified version, which omits these questions will be used. The same rater will evaluate the same participants whenever possible, and at the same time of day. Raters must be certified in the use of the MDS-UPDRS.

Time Frame

26 weeks

Title

Movement Disorders Society Unified Parkinson's Disease Rating Scale, Part 4 (MDS-UPDRS 4)

Description

The MDS-UPDRS Part 4 assesses motor complications the person with Parkinson's has experienced over the past week. Part 4 covers time of the waking day spent with dyskinesias, and impact of dyskinesias. It also assesses motor fluctuations, including: Time spent in OFF state, functional impact of fluctuations, predictability of OFF episodes, and painful OFF state dystonia. Scores in each category are rated from "0" (normal) to "4" (severe).

Time Frame

26 weeks

Title

EuroQol-5 Dimensions (EQ-5D-5L)

Description

The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D is a standardized measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal. The instrument comprises a short descriptive system questionnaire covering five areas which assess quality of life issues, and a visual analogue scale (EQ VAS) that provides a simple descriptive profile of a respondent's health state. The 5L refers to five levels (0-4) of increasing severity for each question.

Time Frame

26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 More than 50% of the waking day spent in the OFF state More than 25% (>4 hours/day) of bothersome dyskinesias 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 -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dan Adams

Phone

8014947804

dan.adams@photopharmics.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ray Dorsey, MD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

In addition to submitting the study design and results to www.clinicaltrials.gov, the final results of the study will be published in a peer-reviewed journal after the generation of the clinical study report. Subsequent to publication and FDA submission, PhotoPharmics intends to make the data available to qualified researchers for collaboration. The general results of the trial may also be made available to study participants during a webinar.

Learn more about this trial

DB RCT for Specialized Phototherapy in Parkinson's Disease.

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