Doctors in the U.K. are planning a “mega-trial” to investigate several marketed therapies — at the same time — as potential treatments to halt the progression, or even reverse the disabilities, of multiple sclerosis (MS).
The world-first Octopus trial, named for its various arms, will enable researchers to concurrently assess multiple MS treatments, potentially advancing their development three times faster than if they were tested in separate trials.
Expected to start this year in the U.K., the study — created by the MS Society — will recruit hundreds of patients with progressive MS. Researchers are in the process of selecting the first three therapies to be included in the trial, but say that that Octopus has enough flexibility to include new treatments are they are discovered, and drop others that don’t look so promising.
“Despite the pandemic, we’re powering full steam ahead with plans for our ‘mega-trial’ for progressive MS, now named Octopus,” Emma Gray, assistant director of research at the MS Society, said in a press release.
Funded by the MS Society through its Stop MS appeal, the study will be led by Jeremy Chataway, PhD, and Mahesh (Max) Parmar, PhD, both from University College London, who have now signed official contracts.
“This is a major milestone. After years of planning, our ambition to speed up clinical trials for progressive MS is going to become a reality,” Gray said.
While several treatments are available for people with relapsing MS, the list is much more limited for patients with progressive disease, which is marked by steadily worsening symptoms. But developing new treatments takes a long time, as each drug must undergo multiple phases of clinical testing before being considered for approval.
The Octopus trial aims to accelerate the clinical development of treatments for progressive MS — which includes primary progressive MS (PPMS) and secondary progressive MS (SPMS) — by combining several of these phases into a single trial and by testing multiple treatments against a single control group.
This is the first multi-arm and multi-stage clinical study being done in multiple sclerosis. Participants will be randomly assigned to receive one of the therapies being tested in the mega-trial or a placebo, while continuing to receive their standard treatment for progressive MS.
After 18 months, patients will have a magnetic resonance imaging (MRI) scan to determine if their assigned therapy slowed the worsening of MS lesions, or even repaired existing nerve damage.
If a medication shows therapeutical benefits, hundreds more patients can be enrolled in the trial, to gather more data on its efficacy and side effects. In contrast, if a therapy is having no effect as measured in brain scans, it can be replaced with another medicine. Having one mega-trial will eliminate the need for separate patient enrollment in different studies and speed the therapies’ development.
To make this mega-trial a reality, many factors had to be carefully planned, such as making sure that participating hospitals have the necessary equipment to serve as trial sites. Another key factor was defining the complicated statistics associated with this trial design given its many arms.
The researchers are still finalizing that design, but hope to initiate patient recruitment in the fall, Gray said.
“By 2025 we hope to be in the late stages of testing treatments,” she added.
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