Namisol™ with Alitra™ DDT – Clinical Studies

Phase I studies and presentations:

  • First In Human Trial of an Oral Tablet with Δ9-THC Namisol. Linda E. Klumpers et al.; Eur. J. of Neurol. 17 (Supplement 3), p 493. Poster presented at the EFNS congress 2010.
  • THC tablet NAMISOL: first in human PK, PD and tolerability. Linda E. Klumpers et al. Poster presented at the FIGON Dutch Medicines Days 2010.
  • First in human trial of an oral tablet with Δ9-THC (NAMISOL). Tim L. Beumer et al. Oral presentation at the IACM conference 2011.
  • Novel Δ(9)-tetrahydrocannabinol formulation Namisol has beneficial pharmacokinetics and promising pharmacodynamic effectsLinda E. Klumpers et al. Br J Clin Pharmacol. 2011; 74 (1): 42-53.
  • Safety and pharmacokinetics of oral delta-9-tetrahydrocannbinol in healthy older subjects: A randomized controlled trial. Amir I.A. Ahmed et al. European Neuropsychopharmacology 2014: 24: 1475-1482.

 

Phase II studies in MS:

  • Effects on Spasticity and Neuropathic Pain of an oral formulation of Δ9-tetrahydrocannbinol in patients with progressive multiple sclerosis. Guido van Amerongen et al. Clinical Therapeutics 2017: x(x):xx-xx (Epub).

 

Phase II studies and presentations in Dementia:

  • Two phase, repeated crossover study with dose escalation on delta-9-tetrahydrocannabinol (delta-THC) in behavioral disturbances in dementia. Geke van Elsen et al. Poster presented at the IPA congress 2011.
  • Safety, pharmacodynamics and pharmacokinetics of multiple oral doses of delta-9-tetrahydrocannabinol in older persons with dementia. Amir I.A. Ahmed et al. Psychopharmacology 2015; 232: 2587-2595.
  • Tetrahydrocannabinol for neuropsychiatric symptoms in dementia. A randomized controlled trial. Geke A.H. van den Elzen et al. Neurology 2015; 84: 2338-2346.

 

Phase II studies in Pain:

  • Single dose delta-9-tetrahydrocannabinol in chronic pancreatitis patients: analgesic efficacy, pharmacokinetics and tolerability. Marjan de Vries et al. Br. J. of Clinical Pharmacology 2015; 81 (3): 525-537.
  • Tetrahydrocannabinol does not reduce pain in patients with chronic abdominal pain in a Phase 2 placebo-controlled study. Marjan de Vries et al. Clinical Gastroenterology and Hepatology 2017; 15: 1079-1086.
  • Effect profile of paracetamol, Δ9-THC and promethazine using an evoked pain test battery in healthy subjects. G. van Amerongen et al. European Journal of Pain 2018:xx;xx-xx (Epub).

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