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Challenges included specialized equipment, interaction with multiple departments and stringent COVID restrictions.

SITUATION

George Clinical was chosen by a biopharmaceutical company focused on neurodegenerative disease to conduct a Phase II, randomized, double-blind, parallel group, placebo controlled clinical trial for the treatment of visual pathway deficits in chronic optic neuropathy. The study assessed the efficacy, safety, tolerability and pharmacokinetics of a bioenergetic nanocatalyst as a remyelinating and neuro-reparative treatment in stable relapsing multiple sclerosis (MS) patients with chronic visual impairment. Remyelination therapy is not a cure, but can bring hope and maybe even a reversal of symptoms for many who are severely affected by MS.

Today, all available MS medications are for slowing progression or relieving symptoms. There is no cure, and no current treatment promotes repair of the long-term neuronal damage. Remyelination is a new and exciting treatment approach that can actually restore neuronal function, prevent further damage and potentially reverse the expected outcome of disability for MS patients. The nanocatalyst in this study has been shown to have the potential to drive meaningful neurological improvements, giving MS patients hope for a treatment that actually improves their condition.

This study sought to improve vision for MS patients and was unique in involving both ophthalmic and neurologic experts, very specific equipment and long assessments for patients. It required special training, persistence, compassionate understanding of patients and a longterm commitment by all stakeholders to move this study forward and pursue this potential life-changing treatment. It was conducted in both Australia and North America.

George Clinical was a good fit for this study due to the flexibility and dedication of our people and our deep experience in Australia. Team members were motivated by the possibility of a treatment that could ultimately provide such rich benefits. For this study, George Clinical provided investigator payments, medical monitoring, project management, quality management, regulatory services, safety management and site management.

CHALLENGES

Initial startup was delayed with necessary protocol amendments prior to ethics approval. Some systems and processes required extra efforts and a high level of communication and trust among stakeholders to accomplish. The complex technical equipment provided by the sponsor necessitated extensive training and a time-consuming certification process.