Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Study of Light Therapy as an Adjunctive Treatment for Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02175472
Recruitment Status : Completed
First Posted : June 26, 2014
Results First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
PhotoPharmics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson Disease
Interventions Device: Spectramax light therapy device
Device: Control light device
Enrollment 92
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Spectramax Light Therapy Device Control Light Device
Hide Arm/Group Description

Light therapy device which emits a specific bandwidth combination and intensity of light.

Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.

Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response.

Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.

Period Title: Overall Study
Started 45 47
Completed 38 45
Not Completed 7 2
Arm/Group Title Spectramax Light Therapy Device Control Light Device Total
Hide Arm/Group Description

Light therapy device which emits a specific bandwidth combination and intensity of light.

Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.

Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response.

Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.

Total of all reporting groups
Overall Number of Baseline Participants 45 47 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 47 participants 92 participants
70.3  (7.94) 65.9  (7.55) 68.0  (8.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 92 participants
Female
12
  26.7%
17
  36.2%
29
  31.5%
Male
33
  73.3%
30
  63.8%
63
  68.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 92 participants
American Indian or Alaska Native
0
   0.0%
1
   2.1%
1
   1.1%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
45
 100.0%
46
  97.9%
91
  98.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 92 participants
Netherlands 15 15 30
United States 30 32 62
1.Primary Outcome
Title Change in the Combined Scores (Sum) of Parts I, II, and III of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (M (MDS-UPDRS) From Baseline to Endpoint at 6 Months.
Hide Description

Part I: 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.

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.

Part III: Motor Examination: This portion of the scale assesses the motor signs of PD and is administered by the evaluator. There are 18 questions, however several questions have multiple parts which are also scored. Each question 0-4, Total range=0-132. Higher score=more severe

Time Frame Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spectramax Light Therapy Device Control Light Device
Hide Arm/Group Description:

Light therapy device which emits a specific bandwidth combination and intensity of light.

Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.

Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response.

Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.

Overall Number of Participants Analyzed 44 47
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-17.7  (2.8) -9.7  (3.5)
2.Secondary Outcome
Title Change in the Clinical Global Impression- Improvement Scale (CGI-I) From Baseline to Endpoint at 6 Months.
Hide Description The Clinical Global Impression of Improvement is an assessment of the clinician's view of the patient's global functioning. Participants are ranked "O" at baseline. The CGI-I ranks 0 - 7, with "0" being much improved, "4" being neutral, and "7" being much worse.
Time Frame Six months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spectramax Light Therapy Device Control Light Device
Hide Arm/Group Description:

Light therapy device which emits a specific bandwidth combination and intensity of light.

Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.

Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response.

Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.

Overall Number of Participants Analyzed 44 47
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.6  (0.1) -0.2  (0.1)
3.Secondary Outcome
Title Change in the Score of the Parkinson's Disease Questionnaire - 39 From Baseline to Endpoint at 6 Months
Hide Description

The 39 question Parkinson's Disease Questionnaire (PDQ-39) is a widely used patient reported rating scale 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

The questions are divided into eight measurement scales each comprising 3 to 10 questions. The scores for the questions in each scale are totaled and normalized to a scale of 0 - 100, that is equivalent to percent of maximum score. The scales are; Mobility (MOB): Q1-10; Activities of Daily Life (ADL): Q11-16; Emotional Well Being (EMO): Q17-22; Stigma (STI): Q23-26; Social Support (SOC): Q27-29; Cognitions (COG): Q30-33; Communication (COM) Q34-36; and Bodily Discomfort (BOD): Q37-39.

Time Frame Six months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spectramax Light Therapy Device Control Light Device
Hide Arm/Group Description:

Light therapy device which emits a specific bandwidth combination and intensity of light.

Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.

Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response.

Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.

Overall Number of Participants Analyzed 44 47
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.3  (2.1) 4.3  (1.7)
4.Secondary Outcome
Title Change in the Score of the Parkinson's Disease Sleep Scale-Disturbed Sleep, From Baseline to Endpoint at 6 Months.
Hide Description The Parkinson's Disease Sleep Scale 2 (PDSS-2) is designed to assess nocturnal disability in Parkinson's disease. The PDSS-2 is a 15 question analog scale that ranks answers from 0 - 4, with 4 being worse. In addition to an overall assessment of sleep disability three aspects of sleep problems can be obtained; disturbed sleep (total of questions 1-3, 8 and 14), PD-specific nocturnal motor symptoms (total of questions 4-6, 12 and 13), and PD-specific nocturnal symptoms (Total of questions 7, 9-11 and 15). We selected the "Disturbed Sleep" subscale as a key secondary outcome measure. This subscale has a total range of 0 - 16, with 16 being more severe.
Time Frame Six months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spectramax Light Therapy Device Control Light Device
Hide Arm/Group Description:

Light therapy device which emits a specific bandwidth combination and intensity of light.

Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.

Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response.

Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.

Overall Number of Participants Analyzed 44 47
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.0  (0.6) 0.7  (0.5)
5.Secondary Outcome
Title Change in the Score of the Epworth Sleepiness Scale From Baseline to Endpoint at 6 Months.
Hide 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 Six months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spectramax Light Therapy Device Control Light Device
Hide Arm/Group Description:

Light therapy device which emits a specific bandwidth combination and intensity of light.

Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.

Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response.

Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.

Overall Number of Participants Analyzed 44 47
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.4  (0.6) 0.1  (0.5)
Time Frame Adverse events were collected from baseline through the endpoint at Month 6, as well as the follow-up Month 7. Because the baseine period also included a two week period, the total safety data collection period was 7.5 months.
Adverse Event Reporting Description Adverse events were recorded in the following ways: During the bi-weekly phone calls made by the study coordinator to each patient, during patient evaluations, during post evaluation interviews, and if the patient called to report an adverse event. Participants were asked during the phone calls, evaluations and interviews to report any event.
 
Arm/Group Title Spectramax Light Therapy Device Control Light Device
Hide Arm/Group Description

Light therapy device which emits a specific bandwidth combination and intensity of light.

Spectramax light therapy device: Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.

Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response.

Control light device: The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.

All-Cause Mortality
Spectramax Light Therapy Device Control Light Device
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Spectramax Light Therapy Device Control Light Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/45 (6.67%)      1/47 (2.13%)    
Cardiac disorders     
Transient Ischemic Attack   1/45 (2.22%)  1 0/47 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Hip deterioration  [1]  0/45 (0.00%)  0 1/47 (2.13%)  1
Accident  [2]  1/45 (2.22%)  1 0/47 (0.00%)  0
Rib fracture  [3]  1/45 (2.22%)  1 0/47 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Hip deterioration requiring surgery
[2]
Subject hit by car while walking on sidewalk
[3]
Subject fell and broke 2 ribs
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Spectramax Light Therapy Device Control Light Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/45 (11.11%)      2/47 (4.26%)    
Eye disorders     
Eye disorders and other eye related problems   5/45 (11.11%)  5 2/47 (4.26%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dan Adams
Organization: PhotoPharmics, Inc.
Phone: 801-770-6960
EMail: dan.adams@photopharmics.com
Layout table for additonal information
Responsible Party: PhotoPharmics, Inc.
ClinicalTrials.gov Identifier: NCT02175472    
Other Study ID Numbers: CT1301
First Submitted: June 24, 2014
First Posted: June 26, 2014
Results First Submitted: July 23, 2018
Results First Posted: October 23, 2018
Last Update Posted: October 23, 2018