Clinical Studies and Case Reports

On this site you will find clinical studies with cannabis or single cannabinoids in different diseases and case reports on the use of cannabis by patients.
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TitleEarly Survival of Comatose Patients after Severe Traumatic Brain Injury with the Dual Cannabinoid CB1/CB2 Receptor Agonist KN38-7271: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial.
Author(s)Firsching R, Piek J, Skalej M, Rohde V, Schmidt U, Striggow F; the KN38-7271 Study Group.
Journal, Volume, IssueJ Neurol Surg A Cent Eur Neurosurg. 2012 Jun 13. [Epub ahead of print]
Major outcome(s)Survival rates within 1 month of the injury were significantly better.
IndicationTraumatic brain injuryAbstract
MedicationOther cannabinoids

Background and Study Object Despite many drug trials, no substance has yet been
identified that improves the outcome of severe head injury. The dual cannabinoid
CB1/CB2 receptor agonist KN38-7271 mediates potent neuroprotection in animal
models. We describe here the first randomized, double-blind, prospective,
placebo-controlled clinical phase IIa proof-of-concept trial to investigate the
safety, pharmacokinetics, and potential efficacy of a cannabinoid receptor
agonist in humans.Patients and Methods Out of the 439, 97 comatose patients at 14
European neurosurgical centers met the inclusion criteria. KN38-7271 was
administered within 4.5 hours of the injury, and the patients received 1000, 500
μg, or placebo. The primary analysis was pharmacokinetic; efficacy was measured
by survival and by neurological improvement or deterioration 7 and 14 days and 1,
3, and 6 months after the injury. Intracranial pressure (ICP) and cerebral
perfusion pressure (CPP) were analyzed from start of treatment to end of day
7.Results Survival rates within 1 month of the injury were significantly better
in the treatment groups than in the placebo group (high-dose, Kaplan-Meier
difference on day 30 + 0.12 with p = 0.043; low-dose, difference +0.15 with p =
0.011) but this effect was not seen after 6 months. Critical ICP and CPP were
less extreme and less frequent in the treatment group. There were no severe and
no serious adverse effects that could be attributed to KN38-7271.Conclusions
KN38-7271 appeared beneficial in the acute early phase of the comatose patient
after a head injury. Its use was safe and well tolerated by patients. These
results may provide the basis for further phase II/III trials in larger study
populations.

Route(s)
Dose(s)0.5 or 1 mg
Duration (days)1
Participants97 comatose patients with head injury
DesignControlled study
Type of publicationMedical journal
Address of author(s)Klinik für Neurochirurgie, Universitätsklinikum, Otto-von-Guericke-Universität Magdeburg, Magdeburg, Germany.
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