Last updated on November 2017

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of CX-8998 for Essential Tremor

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Essential Tremor
  • Age: 18 Years
  • Gender: Male or Female
  • Other:
  • Signed informed consent form indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
  • Men or non-pregnant, non-breastfeeding women 18 years-of-age or older who are able to read and understand English.
  • Diagnosis of definite or probable essential tremor (ET) as defined by the Tremor Investigational Group with involvement of the hands and arms without present causes of enhanced physiologic tremor (Deuschl et al.,1998).
  • Diagnosis of ET before the age of 65
  • Tremor severity score of at least 2 in at least one upper extremity on the TETRAS scale.
  • Total TETRAS performance score of at least 15 (Note: Thresholds of criteria 5 and 6 shall NOT be shared with study subjects or caregiver to limit Baseline-inflation.)
  • Has, in the opinion of the investigator, had an inadequate response to at least one anti-tremor medication(s) or cannot tolerate available anti-tremor medication(s).
  • Subjects with reproductive capability including all males and women of child-bearing potential (WOCBP) must agree to practice continuous abstinence or adequate contraception methods from time of signing informed consent until at least 30 days after the last dose (i.e., intermittent abstinence based on "rhythm", temperature monitoring, or other means of timing is not acceptable). Male subjects with a partner of child-bearing potential must be surgically sterilized or be willing to use condoms with spermicide from the first dose of study drug until at least 30 days after the last dose.

You may not be eligible for this study if the following are true:

  • Exposure to tremorigenic drugs or drug withdrawal states within the past month
  • Direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor
  • History or clinical evidence of psychogenic tremor origin
  • Known history of other medical conditions that may cause or explain subject's tremor, including, but not limited to:
  • Parkinson's disease
  • Hyperthyroidism
  • Pheochromocytoma
  • head trauma or cerebrovascular disease within 3 months prior to the onset of essential tremor
  • multiple sclerosis
  • polyneuropathy
  • family history of Fragile X syndrome
  • Prior MR-guided Focused Ultrasound or surgical intervention for treatment of tremor