Santhera and NIH Collaborate to Evaluate Catena® in Primary Progressive Multiple Sclerosis
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Santhera Pharmaceuticals has announced collaboration with the US National Institutes of Health (NIH) to investigate Catena® as potential treatment of Primary Progressive Multiple Sclerosis (PPMS).
An estimated 150,000 to 300,000 patients worldwide suffer from this rare but devastating form of Multiple Sclerosis. The Phase I/II trial consists of a one-year observational and a two-year interventional period.
The IPPoMS (Idebenone in Patients with Primary Progressive Multiple Sclerosis) trial is a Phase I/II study with a 12-month pre-treatment baseline period followed by a double-blind, randomized, placebo-controlled treatment of 24 months duration investigating the safety and efficacy of one dose of Catena® versus placebo.
During the baseline period up to 80 patients will be enrolled to collect patient-specific biomarkers of disease progression as well as longitudinal neuroimaging and clinical data. Selection of the primary outcome measure as well as potential adjustments of the sample size will be based on the analysis of data from pre-randomization baseline period for the first 30 patients.
The adaptive trial design allows for the selection of the measures of tissue destruction of the central nervous system as key outcome parameters. In addition, this specific design was selected to reduce the number of patients usually required for clinical studies in MS.
The IPPoMS study is performed as collaboration between the US National Institute of Neurological Disorders and Stroke (NINDS) at the NIH and Santhera. Under the collaboration, the NIH will conduct the clinical trial while Santhera will supply study medication.
An estimated 150,000 to 300,000 patients worldwide suffer from this rare but devastating form of Multiple Sclerosis. The Phase I/II trial consists of a one-year observational and a two-year interventional period.
The IPPoMS (Idebenone in Patients with Primary Progressive Multiple Sclerosis) trial is a Phase I/II study with a 12-month pre-treatment baseline period followed by a double-blind, randomized, placebo-controlled treatment of 24 months duration investigating the safety and efficacy of one dose of Catena® versus placebo.
During the baseline period up to 80 patients will be enrolled to collect patient-specific biomarkers of disease progression as well as longitudinal neuroimaging and clinical data. Selection of the primary outcome measure as well as potential adjustments of the sample size will be based on the analysis of data from pre-randomization baseline period for the first 30 patients.
The adaptive trial design allows for the selection of the measures of tissue destruction of the central nervous system as key outcome parameters. In addition, this specific design was selected to reduce the number of patients usually required for clinical studies in MS.
The IPPoMS study is performed as collaboration between the US National Institute of Neurological Disorders and Stroke (NINDS) at the NIH and Santhera. Under the collaboration, the NIH will conduct the clinical trial while Santhera will supply study medication.
