Avextra22 May 2023 20:51
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German 400 person trial for avextra
People with chemotherapy-induced polyneuropathy (CINP) often suffer not only from the tumor itself, but also from the consequences of tumor therapy. In addition, medication for CINP-related pain can further impair quality of life. One problem is that antineuropathic drugs are often not well tolerated.
Patients experience the greatest impairment of central nervous system sedative effects such as drowsiness, fatigue, somnolence, and dizziness," reported Dr. Johannes Horlemann, Kevelaer, President of the German Society for Pain Medicine (DGS). A therapy that builds up the patient instead of depressing it is desirable.
Whether a full-spectrum cannabinoid extract could be a suitable supplement is now to be examined in a real-world study. Together with Avextra, the DGS plans to investigate the efficacy and safety of a THC/CBD full-spectrum extract (10mg/10mg, cultivar Jack Haze) compared to a non-cannabis-based comparator therapy using a prospective, non-interventional, 12-week parallel group study. The composite endpoint includes pain intensity, pain-related impairments, sleep disturbances, and neuropathic pain phenotype. According to PD Dr. Michael Überall from Nuremberg, Vice President of the DGS, this special cultivar was chosen because the accompanying spectrum of terpenes could also be relevant for the treatment of CINP. It contains, for example, nerolidol, beta-caryophyllene and terpinolene. A total of 400 adult subjects with CINP and a pain intensity of at least 40 mm on the visual analogue scale are to be included. With the help of the digital platform iDoc Live®, data are generated in this study that can provide an evidence base for future therapy decisions even before an approval study.
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