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

• ClinicalTrials.gov Identifier: NCT04453033
• Recruitment Status: Not yet recruiting
• First Posted: July 1, 2020
• Last Update Posted: September 9, 2022
• Sponsor: PhotoPharmics, Inc.
• Collaborator: University of Rochester
• Information provided by (Responsible Party): PhotoPharmics, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Device: Celeste Specialized Phototherapy Device	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
• Primary Purpose: Treatment
• Official Title: Double-blind, Randomized Controlled Trial to Demonstrate Efficacy of Celeste® Specialized Phototherapy in Treating Parkinson's Disease.
• Estimated Study Start Date: December 2022
• Estimated Primary Completion Date: July 2024
• Estimated Study Completion Date: November 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Device: Celeste Specialized Phototherapy Device; Ocular phototherapy light panel
Sham Comparator: 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.	Device: Celeste Specialized Phototherapy Device; Ocular phototherapy light panel

Outcome Measures

Primary Outcome Measures :

1. Parkinson's Disease Questionnaire-39 (PDQ-39) [ Time Frame: 26 weeks ]
   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 :

1. Movement Disorders Society-Unified Parkinson's Disease Rating Scale, Sum or Parts 1+2 [ Time Frame: 26 weeks ]

   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.

Other Outcome Measures:

1. Epworth Sleepiness Scale (ESS) [ Time Frame: 26 weeks ]
   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.
2. Beck Depression Inventory -II (BDI-II) [ Time Frame: 26 weeks ]
   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.
3. Beck Anxiety Scale (BAI) [ Time Frame: 26 weeks ]
   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.
4. Scales for Outcomes in Parkinson's Disease - Sleep (SCOPA-Sleep) [ Time Frame: 26 weeks ]
   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.
5. Cogstate Brief Battery (CBB) [ Time Frame: 26 weeks ]
   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.
6. Fatigue Severity Scale (FSS) [ Time Frame: 26 weeks ]
   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
7. Montreal Cognitive Assessment (MoCA) [ Time Frame: 26 weeks ]
   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.
8. Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part 3 (Modified) [ Time Frame: 26 weeks ]
   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.
9. Movement Disorders Society Unified Parkinson's Disease Rating Scale, Part 4 (MDS-UPDRS 4) [ Time Frame: 26 weeks ]
   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).
10. EuroQol-5 Dimensions (EQ-5D-5L) [ Time Frame: 26 weeks ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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Contacts and Locations

Contacts

Contact: Dan Adams; 8014947804; dan.adams@photopharmics.com

Sponsors and Collaborators

PhotoPharmics, Inc.

University of Rochester

Investigators

• Principal Investigator: Ray Dorsey, MD; University of Rochester

More Information

• Responsible Party: PhotoPharmics, Inc.
• ClinicalTrials.gov Identifier: NCT04453033
• Other Study ID Numbers: CSP-PD 01
• First Posted: July 1, 2020
• Last Update Posted: September 9, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• 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.: No

Additional relevant MeSH terms:

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