A Pilot Efficacy and Safety Study of ST101 in Essential Tremor

NCT01332695 | Completed Phase 2

• 1 other identifier: ST101-A002-203
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Tremor

Keywords

tremor; WHIGET; Fahn Tolosa Marin Scale

Outcome Measures

Primary Outcomes (1)

• Washington Heights-Inwood Genetic Study of Essential Tremor (WHIGET) Rating Scale

  The WHIGET Rating Scale is a 6-item scale. Ratings are performed for the right and left side for each activity. Each subject is videotaped in the same manner performing set activities, which are then rated. Rated tasks involve fine motor skills. Each item is scored by an independent, central, blinded reader, and the item scores are summed to provide a total score. Total score range is from 0 to 48, with an increase in score reflecting an increase in ET severity.

  Baseline, Week 3, Week 5, Week 8

Secondary Outcomes (3)

• 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

Study Arms (2)

ST101

EXPERIMENTAL

ST101 oval tablets

Drug: ST101

Placebo

PLACEBO COMPARATOR

oval tablets to match ST101 tablet

Drug: Placebo

Interventions

ST101 DRUG

tablets for oral administration

ST101

Placebo DRUG

placebo to match

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonexa Therapeutics, Inc.: lead

Study Sites (1)

Unknown Facility

Los Angeles, California, United States

Location

MeSH Terms

Conditions

Essential Tremor; Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 11, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 6, 2012

Record last verified: 2012-01

Locations

US (1)