September 2024
New phase 1 trial showcases Neurological Institute’s interdisciplinary study capabilities
Early this summer, Cleveland Clinic researchers enrolled the first patient in a phase 1 trial of an investigational medication for treatment of cognitive impairment in people with multiple sclerosis (MS). Beyond being one of the first clinical studies of a therapy for this potential indication, for which no treatments currently exist, the study is notable for Cleveland Clinic’s role in its design and execution.
“The company developing the medication asked us if we could design the study for them,” says Robert Fox, MD, a neurologist with Cleveland Clinic’s Mellen Center for Multiple Sclerosis Treatment and Research and the study’s principal investigator. “We decided to take them up on the offer, and they ultimately asked us to conduct the trial as well. Cleveland Clinic has done a good bit of clinical trial design in the past in the neurological space. We have the comprehensive multidisciplinary expertise and the structural organization to make it happen efficiently, so it’s a service we look forward to continuing to offer going forward.”
An ideal research arrangement
Specifically, Cleveland Clinic entered into a consultant agreement with the medication’s developer. Drawing on diverse teams, they designed the trial protocol and the data safety and monitoring plan, developed the investigational new drug (IND) application to the FDA and developed a detailed budget for the trial.
“We tapped into the expertise of our MS clinical trial designers in the Mellen Center as well as the advanced imaging specialists in the Mellen Center’s radiology group,” explains Dr. Fox, who additionally serves as Vice Chair for Research in Cleveland Clinic’s Neurological Institute. “We also leveraged neuropsychologists from within our Neurological Institute as well as two teams from Cleveland Clinic’s Lerner Research Institute — biomedical engineers for advanced MRI analysis and biostatisticians from the Department of Quantitative Health Sciences.”
After the drug’s developer reviewed the full study plan, they offered Cleveland Clinic a contract to conduct the single-center phase 1 trial as well. “We accepted, as we have deep experience in all stages of clinical trials for neurological therapeutics and can leverage assets like our advanced, high-field 7T MRI scanner,” Dr. Fox explains. “This is an appealing type of arrangement, as small biopharmaceutical companies often aren’t staffed to design and implement clinical trials in-house. This gives Cleveland Clinic an opportunity to serve the scientific community by designing and running these trials as pure researchers, without the complications of owning the intellectual property.”
Focus of the study
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