Open Norway: Plasma cell aimed treatment with daratumumab in ME/CFS (ResetME) - Haukeland University Hospital

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.

 
DHagen said:
Is ten patients (fewer than phase 1) what has been discussed previously for phase 2, or is this new information?
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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.
 
Utsikt said:
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.
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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.
 
wingate said:
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.
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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?
 
wingate said:
At what point would patients be able to access the drug?
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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.
 
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