Open A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Joel L Young, 2020

[John Mac]

Recruitment Status : Not yet recruiting
First Posted : November 9, 2020
Last Update Posted : November 9, 2020

Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : August 1, 2021

Brief Summary:
This study is an 8-week single center, randomized, double-blind, placebo-controlled, flexible titration trial evaluating the efficacy of solriamfetol in the treatment of fatigue symptoms in adult patients with chronic fatigue syndrome. Subjects will be randomized to a solriamfetol group or placebo group. The investigators will utilize an intent to treat model and impute data. The overall goal of this study is to determine the efficacy and effectiveness of solriamfetol for treating chronic fatigue syndrome.

https://www.clinicaltrials.gov/ct2/show/NCT04622293

Young said he will also open a new clinical trial sometime in the fall, hopefully recruiting 50 patients to test the efficacy of the drug Sunosi (solriamfetol), which is prescribed for excessive daytime sleepiness due to obstructive sleep apnea or narcolepsy.

https://thejewishnews.com/2020/10/07/new-hope-for-chronic-fatigue-sufferers/

 

[Trish]

Why would it be appropriate to treat pwME with a stimulant used to treat excessive daytime sleepiness? I see from drug information that it
"increases systolic blood pressure, diastolic blood pressure, and heart rate in a dose dependent fashion."

I suspect the outcome will be a false feeling of more energy followed by a crash.

 

[Andy]

Self reported outcome measures.

IOM selection criteria.

• All sexually active males or females of child baring potential must agree to practice two different methods of birth control or remain abstinent during the course of the trial. Methods of birth control or contraception will be logged. Male and female contraception will be continued throughout the study and for 30 days after study discontinuation. Women of childbearing potential must test negative for pregnancy at the Screening Visit.

Solriamfetol is a norepinephrine–dopamine reuptake inhibitor (NDRI).

A norepinephrine–dopamine reuptake inhibitor (NDRI) is a drug used for the treatment of clinical depression, attention deficit hyperactivity disorder (ADHD), narcolepsy, and the management of Parkinson's disease. The drug acts as a reuptake inhibitor for the neurotransmitters norepinephrine and dopamine by blocking the action of the norepinephrine transporter (NET) and the dopamine transporter (DAT), respectively.[1] This in turn leads to increased extracellular concentrations of both norepinephrine and dopamine and, therefore, an increase in adrenergic and dopaminergic neurotransmission.[1]

It's an amphetamine derivative, so I don't hold out much hope.

 

[Trish]

From the website linked in the first post:

Link to ADHD?
Young has developed the hypothesis that many of the people who have symptoms of ME/CFS may have what could be considered “ADHD inattentive type” as they get older. Essentially, their ADHD symptoms have manifested themselves as fatigue, he said.

Building on that concept, Young obtained independent funding and published a study in 2012 in the journal Psychiatry Research about the effects of LDX (lisdexamphentamine) — also known commercially as Vyvanse — on those with ME/CFS. Vyvanse has been approved by the FDA to treat ADHD as well as binge-eating disorder, although not specifically for ME/CFS.

“We found that patients with ME/CFS who were treated with LDX have far less fatigue and pain than those treated with placebo,” he said.

The case of 'Jane' described in the article sounds like someone with depression, possibly not ME.

 

[Trish]

Thread about him and his theories here:
https://www.s4me.info/threads/psych...c-fatigue-joel-l-young-m-d.16304/#post-280684

 

[Mij]

The term CFS will continue to haunt us forever when it comes to these studies. I'm pretty sure this medication will keep us up all night

 

[Sly Saint]

see also
https://www.s4me.info/threads/adhd-drugs-for-chronic-fatigue-syndrome-how-well-do-they-work.1204/

 

[rvallee]

I prefer medical researchers who understand the difference between somnolence and fatigue, let alone that fatigue is an invalid definition of ME.

Now if only the differences had not been purposely distorted to the point where most medical professionals seemingly swing back and forth between understanding or not understanding the differences depending entirely on context and biases like it's a damn belief system. If only.

 

[oldtimer]

I suspect the outcome will be a false feeling of more energy followed by a crash.

This is exactly my experience with 5 mg of dexamphetamine (family member's ADD medication) taken quite often over ten years or so. The alternative medicine doctor I was seeing in the 1990s would have been happy to prescribe it too.

I was able to get long periods of physically demanding outdoor work done with no effort, but of course paid for it afterwards. Another downside was that I ignored joint and muscle pain and ended up with injuries.

The last time I took it the immediate effect was the exact opposite: severe lack of energy and spaced-out feeling. That really frightened me off it for good.

 

[Jaybee00]

Why would it be appropriate to treat pwME with a stimulant used to treat excessive daytime sleepiness?

Why not? I have daytime fatigue and would like to not have it.

However, I would prefer to see a trial of pitolisant (Wakix) which works by a completely different mechanism. Wakix is very expensive in the USA, but not as expensive in Europe.

In general I support all non psychological clinical trials—nothing ventured, nothing gained.