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Abstract
Background: The prognosis of long-term severe disorders of consciousness due to traumatic brain injury is discouraging. There is little definitive evidence of the underlying mechanisms, but a deficiency of the dopaminergic system may be involved.
Methods: In a prospective open-labelled clinical study, the feasibility, relative efficacy and safety of continuous subcutaneous (s.c.) administration of apomorphine in Vegetative State (VS) or Minimally Conscious State (MCS) patients due to severe traumatic brain injury (TBI) was tested. Apomorphine was administered to eight patients. Outcome measures were the Coma Near-Coma Scale (CNCS) and Disability Rating Scale (DRS).
Results: Drug management was implemented without any problems. There was improvement in the primary outcomes for all patients. Awakening was seen as rapidly as within the first 24 hours of drug administration and as late as 4 weeks. Seven of the patients had completely recovered consciousness. All improvements were sustained for at least 1 year, even after apomorphine was discontinued. Drug-related adverse events were all anticipated and resolved after the dose was reduced.
Conclusion: Based on this open-label pilot study, continuous s.c. apomorphine infusion appears to be feasible, safe and potentially effective in improving consciousness in patients in VS and MCS due to severe TBI.
Acknowledgement
We wish to thank Claudia Navarro for all her efforts at the ANMAT (Argentinean Drugs Administrative Office) and manuscript edition.
Declaration of interest: E.A.F. is an inventor at the Institute for Neurological Research-FLENI of the biotechnology used here. E.R.G. is the Chairman of the Board, and at the time the study was conducted was Acting Head of Clinical Trials for NHPI and paid for his work. E.A.F is consultant and advisor to NHPI, to which the biotechnology has been licensed. NHI provided support for the clinical study reported.