A Pilot Efficacy and Safety Study of ST101 in Essential Tremor

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sonexa Therapeutics, Inc.

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