Clinical trial NCT04453033: DB RCT for Specialized Phototherapy in Parkinson's Disease.
Official title: Double-blind, Randomized Controlled Trial to Demonstrate Efficacy of Celeste® Specialized Phototherapy in Treating Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: PhotoPharmics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Rochester
First posted: 2020-07-01
Enrollment: 300
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

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

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Primary outcomes:
measure: Parkinson's Disease Questionnaire-39 (PDQ-39)
timeFrame: 26 weeks
Secondary outcomes:
measure: Movement Disorders Society-Unified Parkinson's Disease Rating Scale, Sum or Parts 1+2
timeFrame: 26 weeks
Other outcomes:
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 26 weeks
measure: Parkinson's Disease Health Index (PD-HI)
timeFrame: 26 weeks
measure: Beck Depression Inventory -II (BDI-II)
timeFrame: 26 weeks
measure: Beck Anxiety Scale (BAI)
timeFrame: 26 weeks
measure: Scales for Outcomes in Parkinson's Disease - Sleep (SCOPA-Sleep)
timeFrame: 26 weeks
measure: Fatigue Severity Scale (FSS)
timeFrame: 26 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 26 weeks
measure: Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part 3 (Modified)
timeFrame: 26 weeks
measure: Movement Disorders Society Unified Parkinson's Disease Rating Scale, Part 4 (MDS-UPDRS 4)
timeFrame: 26 weeks
measure: EuroQol-5 Dimensions (EQ-5D-5L)
timeFrame: 26 weeks
measure: Parkinson's Disease Patient Report of Problems (PD PROP)
timeFrame: 26 Weeks
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Ray Dorsey, MD
role: PRINCIPAL_INVESTIGATOR
References: