Jonathan Edwards
Senior Member (Voting Rights)
It could be but I think other issues are probably more interesting.
Open Norway: Plasma cell aimed treatment with daratumumab in ME/CFS (ResetME) - Haukeland University Hospital
- Thread starter Kalliope
- Start date
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- Tags
- cd38 daratumumab norway resetme
It could be but I think other issues are probably more interesting.
John Mac
Senior Member (Voting Rights)
Study of Daratumumab Injections for Patients with Moderate to Severe Chronic Fatigue Syndrome
What is this study about?
This clinical trial is focused on studying the effects of a medication called daratumumab on patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). ME/CFS is a condition characterized by extreme fatigue that doesn’t improve with rest and can worsen with physical or mental activity. The medication being tested, daratumumab, is given as a subcutaneous injection, which means it is injected under the skin.The purpose of this study is to evaluate the feasibility and safety of using daratumumab in patients with moderate to severe ME/CFS. The study will involve ten patients who will receive the medication over a period of time. Participants will be monitored for any side effects and changes in their condition. The study aims to gather information on how well patients tolerate the treatment and any potential benefits it may provide.
Throughout the study, researchers will track various aspects of the participants’ health, including physical function, bodily pain, and overall activity levels. This will help determine if daratumumab can be a safe and effective treatment option for those suffering from ME/CFS. The study is expected to continue for a set period, allowing researchers to collect comprehensive data on the medication’s impact on the disease.
Utsikt
Senior Member (Voting Rights)
Seems to be the page for the pilot.
John Mac
Senior Member (Voting Rights)
It was showing up as being updated in the last 24 hours so maybe it was just edited.
Is ten patients (same as phase 1) what has been discussed previously for phase 2, or is this new information?
[edited to correct the number of patients from phase 1, which was also 10]
Last edited:
Utsikt
Senior Member (Voting Rights)
This one is for Trial ID: 2024-512500-19-00, which is the pilot.
They’ve described ResetME as a phase 2/3 trial previously. I don’t think the number matters much. If ResetME is positive, an even larger scale might be warranted to get even more data on who it works for and why.
wingate
Senior Member (Voting Rights)
Let’s say ResetME is shows Dara works.
At what point would patients be able to access the drug? Would they have to wait for yet another trial?
Or would a future trial be able to happen concurrently to patients getting the drug outside the trial.
Utsikt
Senior Member (Voting Rights)
If I’ve understood things correctly, it’s normal to approve drugs after a positive phase 3. Then you might do an even larger phase 4 to understand even more about the nuances and long term dynamics.
Others might know if ResetME would be sufficient for approval given a clear cut positive result.
And each country will have their own approval. Maybe EU has some shared schemes for its members?
Kitty
Senior Member (Voting Rights)
When healthcare agencies have seen enough evidence that it works, I guess. It might be that if the results are positive, replication could be attempted in other countries to help broaden the picture across populations. That could also have the advantage of raising the profile of the approach, including among clinicians who're used to working with this class of drugs but for very different diseases.
Utsikt
Senior Member (Voting Rights)
Assuming the study is adequately powered, I’d rather have them spend more money on the current participants to work out dosing quirks and doing follow-up in general.
I suspect the Germans will jump on any opportunity to replicate a -mab study.
Getting something set up to track the use and effect in the general population is also high on my list, if it turns out that Dara works.
V.R.T.
Senior Member (Voting Rights)
I think you're right. And Scheibenbogens CD38 study (ixa something) should provide parallel evidence if that goes ahead.
V.R.T.
Senior Member (Voting Rights)
Do you mean in people who use it off label for ME if ResetME is successful? I think that would be really important.
Utsikt
Senior Member (Voting Rights)
No, in people that get it through the normal systems once it’s accepted for use. If it’s possible to incorporate data from off label use as well, that might be desirable.
Arfmeister
Established Member (Voting Rights)
Patients from Norway have created a petition to encourage the government to provide funding for the Daratumumab study and to strengthen future biomedical research efforts in ME CFS.
(saw and copied post X from @ME/CFS Science Blog )
You can sign the petition here:
(saw and copied post X from @ME/CFS Science Blog )
You can sign the petition here:
Kitty
Senior Member (Voting Rights)
I wish the government and medical research funders would see the PR potential.
Even if it doesn't work, it's still a great story that portrays Norway as a leader in innovation and rigorous science.
If it does, it's a world first. A country whose entire population is less than half that of Los Angeles manages to solve a problem that countries with billions to spend haven't got close to. It'd be a huge coup.
Even if it doesn't work, it's still a great story that portrays Norway as a leader in innovation and rigorous science.
If it does, it's a world first. A country whose entire population is less than half that of Los Angeles manages to solve a problem that countries with billions to spend haven't got close to. It'd be a huge coup.
V.R.T.
Senior Member (Voting Rights)
It's bizarre to me that they don't see this. Ditto the UK and SequenceMEs potentially.
Kalliope
Senior Member (Voting Rights)
I so agree with you and have thought the same many times. This is very little money to invest compared with how much we could be bragging about it afterwards.