The Children’s Tumor Foundation is thrilled to announce that the first-ever clinical trial for schwannomatosis is now open at Massachusetts General Hospital (MGH). The trial is focused on pain, a very important topic for schwannomatosis patients. The Children’s Tumor Foundation is assisting with patient recruitment for the trial.
The clinical trial investigators will test the efficacy and tolerability of tanezumab as a treatment for schwannomatosis patients with chronic pain (who have had inadequate pain relief), in a randomized, placebo-controlled trial, which could then form the basis of a larger, randomized controlled trial in the future.
The study is designed with a total duration of 281 days (40 weeks) and will consist of four periods: Pre-treatment, Double-Blind Treatment, Single Arm Treatment, and 24-Week Safety Follow-up. The Pre-Treatment Period lasting up to 30 days, followed by a Double-Blind Treatment Period lasting up to 8 weeks, followed by a Single Arm Treatment Period lasting up to 8 weeks, and a 24-Week Safety Follow-Up Period ending with the End of Study Visit at week 40.
The primary outcome of this study is to assess if tanezumab results in an improvement compared to the worst pain level. Worst pain levels will be measured before the start of the treatment and from then once per week for 8 weeks using the NRS11 pain intensity scale (1-10). More information about the trial, plus inclusion and exclusion criteria, can be found here.
The Children’s Tumor Foundation is committed to finding treatments for all forms of neurofibromatosis: NF1, NF2, and schwannomatosis. In addition to supporting the above-mentioned trial, CTF hosted a 2-year Synodos for Schwannomatosis consortium, which will be releasing its data to the NF Data Portal in early 2021. Our aim is to increase even more study into the field of schwannomatosis. Please follow this space for further updates in the near future.
