Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-24 @ 2:17 PM
NCT ID:
NCT01332695
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01332695
Study Brief:
Protocol Section:
NCT01332695