- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01332695
A Pilot Efficacy and Safety Study of ST101 in Essential Tremor
January 4, 2012 updated by: Sonexa Therapeutics, Inc.
A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Safety, Tolerability and Proof of Concept Study of ST101 for Essential Tremor
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ST101
ST101 oval tablets
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tablets for oral administration
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Placebo Comparator: Placebo
oval tablets to match ST101 tablet
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placebo to match
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Washington Heights-Inwood Genetic Study of Essential Tremor (WHIGET) Rating Scale
Time Frame: Baseline, Week 3, Week 5, Week 8
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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.
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Baseline, Week 3, Week 5, Week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Disabilities Scale
Time Frame: Screening, Baseline, Weeks 3, 5, 8
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An 8-Item functional scale that assesses the following functional domains: Speaking/Phonation, Feeding (other than liquids), Bringing Liquids to Mouth, Hygiene, Dressing, Writing, Working, and Social Activities.
Higher scores indicate worsening of disease.
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Screening, Baseline, Weeks 3, 5, 8
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Clinical Global Impression of Change
Time Frame: Week 3, Week 8
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A 7-point Likert scale with Marked Worsening to Marked Improvement at the extremes, and Unchanged in the center.
Scores range from -3 to +3 wherein negative scores indicate worsening, while positive scores indicate improvement.
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Week 3, Week 8
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Subject Clinical Global Impression of Change
Time Frame: Week 3, Week 8
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A global visual analog scale (VAS) which is a 100 mm horizontal line on which the subject indicates their overall assessment of response to study drug by making a mark on the horizontal line.
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Week 3, Week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
April 7, 2011
First Submitted That Met QC Criteria
April 8, 2011
First Posted (Estimate)
April 11, 2011
Study Record Updates
Last Update Posted (Estimate)
January 6, 2012
Last Update Submitted That Met QC Criteria
January 4, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ST101-A002-203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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