A Pilot Efficacy and Safety Study of ST101 in Essential Tremor

A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Safety, Tolerability and Proof of Concept Study of ST101 for Essential Tremor

Sponsors

Lead Sponsor: Sonexa Therapeutics, Inc.

Source Sonexa Therapeutics, Inc.
Brief Summary

This study will look at the ability of ST101 to treat symptoms in subjects with Essential Tremor. This study will also examine the safety and tolerability of the drug. This study is evaluating one dose level of ST101 versus placebo in a cross-over fashion. This means that all patients will receive both ST101 and placebo, but they will receive it in a random (by chance) order.

Detailed Description

Essential tremor (ET) is a slowly progressive, chronic neurological disorder characterized by a 4- to 12-Hertz tremor, which can involve the arms, head, voice and lower extremities. Although the hallmark of the disorder is thought to be the kinetic tremor, ET patients usually also manifest a postural tremor as well. Kinetic tremor (tremor with voluntary movements) may interfere with fine motor skills (e.g., writing, eating, drinking from a cup, pouring liquids); and depending upon its severity, may result in significant disability and diminished quality of daily living. Essential tremor represents an area of unmet medical need and this study is designed as a safety, tolerability and proof-of-concept investigation of the ability of ST101 to improve tremor. In this 2-stage study, subjects will be randomly assigned to either ST101 or placebo in Stage 1, and will receive the alternate treatment in Stage 2.

Overall Status Completed
Start Date April 2011
Completion Date December 2011
Primary Completion Date December 2011
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Washington Heights-Inwood Genetic Study of Essential Tremor (WHIGET) Rating Scale Baseline, Week 3, Week 5, Week 8
Secondary Outcome
Measure Time Frame
Functional Disabilities Scale Screening, Baseline, Weeks 3, 5, 8
Clinical Global Impression of Change Week 3, Week 8
Subject Clinical Global Impression of Change Week 3, Week 8
Enrollment 25
Condition
Intervention

Intervention Type: Drug

Intervention Name: ST101

Description: tablets for oral administration

Arm Group Label: ST101

Intervention Type: Drug

Intervention Name: Placebo

Description: placebo to match

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria: - Diagnosis of definite or probable essential tremor (ET) as defined by the Tremor Investigational Group with involvement of the hands and arms of at least 2 years duration - Tremor severity score of >/= 2 in at least one upper extremity on the Fahn-Tolosa-Marin Tremor Rating Scale - Subject who is accessible by telephone - Subject who can comply with study visits, study drug compliance, and study procedures. Exclusion Criteria: - Subject whose tremor is adequately controlled on a current treatment - Subject who is pregnant, plans to become pregnant during the study or within 2 months of completing the study or who is presently lactating or breast-feeding - Subject with other medical conditions that may cause or explain subject's tremor - Subject with a recent history of hematologic/oncologic disorders - Subject taking medication(s) that might produce tremor or interfere with the evaluation of tremor - Subject who has had surgical intervention for their tremor in the past (e.g., ablative thalamotomy or gamma knife thalamotomy), or has had a botulinum toxin injection in the 6 months prior to screening

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
Location Countries

United States

Verification Date

January 2012

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: ST101

Type: Experimental

Description: ST101 oval tablets

Label: Placebo

Type: Placebo Comparator

Description: oval tablets to match ST101 tablet

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov