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Trial record 1 of 1 for:    photopharmics
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Efficacy Study of Light Therapy as an Adjunctive Treatment for Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhotoPharmics, Inc.
ClinicalTrials.gov Identifier:
NCT02175472
First received: June 24, 2014
Last updated: April 13, 2017
Last verified: April 2017
  Purpose
Light treatment was originally employed in Parkinson's disease (PD) to determine if it might be effective in treating co-existing symptoms of depression and insomnia. However, a preliminary double-blind study as well as other studies reported significant improvement in both motor and co-existing Parkinsonian symptoms. As of yet, no long term double blind study has validated these findings. This study will use a double-blind design to evaluate the safety and efficacy of a non-invasive light therapy device to be used with ongoing pharmacotherapy for PD, over a six month treatment period.

Condition Intervention
Parkinson Disease Device: Spectramax light therapy device Device: Control light device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Sixty Minute Exposure of Specific Bandwidth Light for the Treatment of Idiopathic Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by PhotoPharmics, Inc.:

Primary Outcome Measures:
  • Change in the combined scores of parts I, II, and III of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to endpoint [ Time Frame: Six Months ]

    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.

    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.

    Part III: Motor Examination: This portion of the scale assesses the motor signs of PD and is administered by the evaluator



Secondary Outcome Measures:
  • Change in the Total Score of MDS-UPDRS from Baseline to Endpoint [ Time Frame: Six months ]
    The Unified Parkinson's Disease Rating Scale has four parts; Part I (non-motor experiences of daily living), Part II (motor experiences of daily living, Part III (motor examination) and Part IV (motor complications). All 4 parts will be completed and a total score will be calculated.

  • Change in the score of the Beck Depression Inventory II from baseline to endpoint [ Time Frame: Six months ]
    Patients will answer a 21-question, multiple-choice inventory for measuring the severity of depression. There is a 4-point score for each question ranging from 0 to 3. The score for each of the 21 questions is summed to give a single score for the BDI-II.

  • Change in the score of the Beck Anxiety Inventory from baseline to endpoint [ Time Frame: Six months ]
    Patients will indicate how much they have been bothered by common symptoms of anxiety during the past month (including the day of the evaluation) by circling a number from 0-3 next to each symptom. The sum of the circled numbers is the score for the Beck Anxiety Inventory.

  • Change in the score of the Parkinson's disease Sleep Scale - 2, from baseline to endpoint [ Time Frame: Six months ]
    Patients will rate the severity of common sleep experiences during the past week (7 days), by indicating a number from 0-4 next to each experience. The sum of the indicated numbers is the score for the Parkinson's Disease Sleep Scale - 2

  • Change in the score of the Epworth Sleepiness Scale from baseline to endpoint [ Time Frame: Six months ]
    Patients will evaluate a list of eight situations in which they rate their tendency to become sleepy by indicating a number from 0-3. The sum of these numbers is the score for the Epworth Sleepiness Scale.

  • Change in the score of the Parkinson's Disease Questionnaire 39 from baseline to endpoint [ Time Frame: Six months ]
    Patients will answer 39 questions regarding how often during the last month PD has affected various items by checking "Never", "Occasionally", "Sometimes", "Often", "Always (or cannot do at all)". These answers will be transformed into numbers from 0-4 and the sum of these numbers for each subpart and the overall sum are the scores for the Parkinson's Disease Questionnaire 39.

  • Change in the score of the Wearing Off - Quick 10 Questionnaire from baseline to endpoint [ Time Frame: Six months ]
    Patients will identify any of 10 listed symptoms they currently experience during a normal day and whether each identified symptom usually improves or disappears after they take their dose of Parkinson's medication. The number of symptoms experienced will be totaled, and the number of symptoms that improve or disappear will be totaled. Patients will also report their impression of improvement on a scale of 0-4 (0: "very much worse", 1: "much worse", 2: "no change", 3: "much improved", and 4: "very much improved").


Enrollment: 92
Study Start Date: June 2014
Study Completion Date: December 23, 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Spectramax light therapy device
Light therapy device which emits a specific bandwidth combination and intensity of light.
Device: Spectramax light therapy device
Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.
Sham Comparator: Control light device
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.
Device: 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.

Detailed Description:

Parkinson's disease (PD) is traditionally described as a disorder of compromised dopamine (DA) function in the nigro-striatal dopamine (NSD) system. This system extends from the midbrain, through the hypothalamus and into the forebrain to critical areas involved in the control of motor performance. Restoration of DA content in this system by administering the DA precursor L-dopa or DA agonists reinstates motor control, but provides only symptomatic relief with waning efficacy as the disease advances. Symptoms of depression and sleep disturbances are also commonly seen in PD patients, and the manifestation of these symptoms suggests impaired circadian function.

Although the involvement of the circadian system in PD was intimated in the first formal account of the disorder provided by James Parkinson, it was not until recently that circadian malfunction has been specifically cited as playing a major role in the development and progression of the disease. In addition to scattered reports depicting circadian-like features of PD and related syndromes, a large body of evidence describes the benefits of light therapy in PD from both the preclinical and clinical perspectives.

While the development of a formal understanding has been largely omitted as to the basis for any therapeutic effect exerted by light, recent studies have shown that the nigro-striatal dopamine system is comprised of the same cell type as cells in the retina and the pineal. Such cells are driven by visual input whereby dopamine and melatonin sit in functional opposition to regulate day night activities including sleep, mood, reproduction, anti-oxidation and movement. Hence one may conclude that the circadian system plays a major role in many aspects of PD.

Recent work in PD has also suggested that the efficacy of light therapy is mediated by melatonin and dopamine function in the retina. On this basis it would be reasonable to assume that intervention into the function of the circadian system with light therapy in PD patients might well serve to modify the course and consequences of the disease. The present study serves to extend this finding to the point of providing a practical, non-invasive method for helping patients.

  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1.Males and females, with Stage II - III, idiopathic Parkinson's disease, as assessed by Hoehn-Yahr Scale
  • 2. On an optimized, stable dopamine replacement therapy for at least 1 month

Exclusion Criteria:

  • 1. Participants younger than 45 years old
  • 2. Participation in a study of investigational or marketed drugs or devices during the 30-day period prior to the prospective subject's Baseline Evaluation or during their involvement in this investigation
  • 3. Subjects who are medically complicated, medically unstable and/or have other severe co-morbid disease states, as determined by the Investigator.
  • 4. History of psychiatric illness that would preclude compliance with the protocol and/or ability to complete the study safely
  • 5. History or current diagnosis of major psychiatric disorder including Bipolar I Disorder that could interfere with accurate assessment and effective treatment
  • 6. Have a Beck Depression Inventory-II (BDI-II) score of greater than or equal to 14
  • 7. An anticipated need for a change in dopamine replacement therapy during the subject's involvement in the investigation
  • 8. Patients on stable anti-depressant dose for less than 6 weeks
  • 9. Less than one month since stopping an anti-depressant or psychoactive medication
  • 10. History of current or recent (within previous 12 months) alcohol, narcotic or other drug abuse by the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria
  • 11. Active suicidal or homicidal ideation or plan as determined by the Investigator or have a score of greater than or equal to 2 on the DBDI-II.
  • 12. Previous use of light therapy treatment
  • 13. Females of childbearing potential, i.e. capable of becoming pregnant
  • 14. Night shift work within the past 6 months or planned during the investigation
  • 15. Have planned travel of more than two weeks outside of two time zones from home during involvement in the Investigation
  • 16. Planned travel outside of two time zones from home during the last two months of the Subject's involvement in the Investigation
  • 17. Current use or use within the previous 1 month of photosensitizing or other medications that in the opinion of the investigator would interfere with the safety of the Subject during the trial including

    • amiodarone
    • benoxaprofen
    • chlorpromazine
    • demeclocycline
    • fleroxacin
    • nalidixic acid
    • ofloxacin
    • piroxicam
    • porfimer
    • psoralens
    • quinidine
    • temoporfin tetracycline
    • oral isoretinoin (Accutane)
    • St. John's wort
    • melatonin
  • 18. Have a history of significant eye trauma or disease, retinopathy, and/or cataract of a level that would significantly affect transmission or processing of light through either eye
  • 19. Other neurological disorders that in the opinion of the Investigator would interfere with the conduct of the study
  • 20. Pre-existing major joint problems that in the opinion of the Investigator would interfere with the conduct of the study
  • 21. History of cerebral insult or central nervous system infection that in the opinion of the Investigator would preclude successful participation in Investigation related procedures
  • 22. Cognitive impairment, e.g. as determined by the Montreal Cognitive Assessment, that in the opinion of the Investigator would interfere with the conduct of the Investigation
  • 23. Focal neurological deficits that in the opinion of the Investigator would interfere with the conduct of the Investigation
  • 24. High dopamine replacement therapy (DART) dosage levels or severe dyskinesia attributable to DART that would preclude successful participation in the Investigation related procedures or interventions in the opinion of the site Investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02175472

Locations
United States, Massachusetts
Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States, 02114
United States, Utah
Aspen Clinical Research
Orem, Utah, United States, 84058
Netherlands
VU University Medical Center (VUmc)
Amsterdam, MB, Netherlands, 1007
Sponsors and Collaborators
PhotoPharmics, Inc.
  More Information

Responsible Party: PhotoPharmics, Inc.
ClinicalTrials.gov Identifier: NCT02175472     History of Changes
Other Study ID Numbers: CT1301
Study First Received: June 24, 2014
Last Updated: April 13, 2017

Keywords provided by PhotoPharmics, Inc.:
Parkinson's disease
Light therapy
Circadian rhythm

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on June 22, 2017