Clinical Trial Details

Overview

Research Study Summary

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

Purpose

This is a double-blind, placebo-controlled, parallel-group study. Subjects will be randomized to one of two treatment groups. Group A will receive CX-8998 and Group B will receive placebo. Subject randomization will be stratified by concomitant primidone use and site type (sub-study vs non sub-study).

Tremor will be assessed via The Essential Tremor Rating Assessment Scale (TETRAS) and accelerometry. In order to reduce rater bias, all subjects will be videotaped during the TETRAS performance scale testing according to a consistent script. The videotapes will be rated in a blinded manner. A subset of subjects will participate in an electroencephalography (EEG) and magnetoencephalography (MEG) sub-study to record power-spectral brain activity in specific neuro-anatomical locations and coherence with movement measures.

Subjects will be screened up to one month prior to initiation of dosing. At Baseline, subjects will undergo safety and tremor assessments prior to dosing, will receive their first dose of study drug and will be monitored for safety for one hour following dosing. For one week subjects will receive 4 mg (or matching placebo) twice daily. Subjects will return to the clinic on Day 8 for safety monitoring and dose up-titration to 6 mg (or matching placebo) twice daily. At Day 15 (Week 3) subjects will return to clinic for safety and efficacy assessments and final dose up-titration to 8 mg (or matching placebo) twice daily. The final efficacy visit will occur at Day 28 (Week 4). A final safety visit will occur at Day 35 (Week 5).

To Learn more

CW ID: 226040
Date Last Changed: August 18, 2017

Clinical Trial Snapshot

Phase
2
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Cavion LLC
Facility Type
N/A

Eligibility

Inclusion Criteria:
  • 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.
Exclusion Criteria:
  • 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

More Info

CX-8998-CLN2-001

Contact

Jessica Shaw
University of South Florida -Morsani Center for Advanced Healthcare
13330 USF Laurel Drive
Tampa, FL 33612

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