Light Therapy Clinical Trial -US - Cure Parkinson's

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Light Therapy Clinical Trial -US

Canddy profile image
9 Replies

Below is some information from clinicaltrials.gov about a light therapy trial that will begin recruitment soon. I have also included an email response from the contact listed on clinicaltrials.gov. you should be able to see the trial at clinicaltrials.gov if you copy and paste the https: address in your browser.

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

clinicaltrials.gov/ct2/show...

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

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 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 Type :Interventional (Clinical Trial)

Estimated Enrollment :200 participants

Allocation:Randomized

Ages Eligible for Study: 45 Years and older (Adult, Older Adult)

Sexes Eligible for Study: All

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

Here is the email response from the CT.gov contact Dan Adams that I received today - June 24, 2021:

The trial hasn’t started yet, and it is a national trial, so anywhere you are in the US, you would be able to participate. The eligibility requirements are pretty inclusive too. But you do need to be on a stable dose of Parkinson’s medication, and you need to have been on medication for at least a year. You’re probably aware that this trial is looking at improving non-motor symptoms in PD, as well as other motor, but the focus is investigating improving things like sleep, cognition, daytime sleepiness, fatigue, depression, anxiety, irritability, apathy, urinary problems, etc.

We will probably start recruiting patients in the early fall, and recruitment will take several months, so you will likely be able to participate.

Best,

Dan

---------------------------------------------------

Dan Adams

Science Officer

M 801.494.7804 O 801.770.6960

dan.adams@photopharmics.com

photopharmics.com

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Canddy profile image
Canddy
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9 Replies
Canddy profile image
Canddy

Actually the link I put in the post should work...

LAJ12345 profile image
LAJ12345

Bright light at night? Won’t that disturb sleep?

Canddy profile image
Canddy in reply to LAJ12345

I am not familiar with the protocol for this study but you can certainly contact Don Adams at PhotoPharmics with your question. Maybe you have to use it a certain number of hours before sleeping? I honestly do not know.

Smittybear7 profile image
Smittybear7 in reply to Canddy

Are there any studies that use people with Parkinsonism but not on medication?

I'm afraid to start medication because of the side effects.

Canddy profile image
Canddy in reply to Smittybear7

Here is a link to the patient experience landing page for PhotoPharmics:

photopharmics.com/patient-e...

You can get on their email list for upcoming clinical trials. You can also email Don Adams (see my original post) as he would be in the best position to answer your question. When I contacted him yesterday via email he replied within 5 minutes. Good luck and please keep this forum posted if you find out about trials on PwP that do not require the person to be on medication.

Smittybear7 profile image
Smittybear7 in reply to Canddy

Thanks

LeharLover62 profile image
LeharLover62 in reply to Canddy

I wondered that too.

LeharLover62 profile image
LeharLover62

I tried purchasing a blue light similar to the Celeste and set it in front of my husband after dinner every night for a few weeks. We didn’t notice anything at all, but maybe the device wasn’t similar enough.

Canddy profile image
Canddy

An update to this PhotoPharmics study for those interested - NCT04453033, CSP-PD 01, DB RCT for Specialized Phototherapy in Parkinson's Disease (the NCT number is the trial number on clinicaltrials.gov)

I emailed CT.gov contact Dan Adams yesterday (October 7, 2021) and again received a rapid reply to my inquiry about when this trial will start:

From: Dan Adams

Sent: Thursday, October 7, 2021 3:48 PM

Subject: RE: NCT04453033, CSP-PD 01, DB RCT for Specialized Phototherapy in Parkinson's Disease.

I’m so glad you’re still interested. We have a few issues to iron out still, and I hope we will be able to start soon. My guess is that will be late this year, or early next. We will let you know though.

Thank you again,

Best,

Dan

---------------------------------------------------

Dan Adams

Science Officer

M 801.494.7804 O 801.770.6960

dan.adams@photopharmics.com

photopharmics.com

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