Comparison of Botulinum Toxin Injections in Forearm FLexor Plus EXtensor Muscles vs. Flexor Muscles Alone for Treatment of Essential Hand Tremor(FLEX-D ET)

NCT ID: NCT02909907

Last Updated: 2019-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-02-28

Brief Summary

To compare the efficacy of botulinum toxin (BoNT) injections in forearm flexors plus extensor muscles versus flexors alone for the treatment of essential hand tremor (ET).

Detailed Description

The investigators propose a pilot, single center, double blind, randomized, parallel, placebo controlled trial comparing 2 (BoNT) injection patterns for treatment of moderate to severe essential tremor. The investigators will recruit 20 patients with (ET).

Conditions

Essential Tremor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

150 units of abobotulinumtoxinA

150 units of abobotulinumtoxinA in flexor compartment of dominant arm (75 units in flexor carpi radialis \[FCR\] and 75 units in flexor carpi ulnaris \[FCU\]) along with placebo in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU)

Group Type: EXPERIMENTAL

Botulinum toxin

Intervention Type: DRUG

Botulinum injections into dominant upper extremity using protocol outlined above.

Placebo

Intervention Type: OTHER

Placebo injections in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) per protocol outlined above

75 units of abobotulinumtoxinA

75 units of abobotulinumtoxinA in FCR and FCU and 25 units in ECR and ECU

Group Type: EXPERIMENTAL

Botulinum toxin

Intervention Type: DRUG

Botulinum injections into dominant upper extremity using protocol outlined above.

Interventions

Botulinum toxin

Botulinum injections into dominant upper extremity using protocol outlined above.

Intervention Type: DRUG

Placebo

Placebo injections in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) per protocol outlined above

Intervention Type: OTHER

Other Intervention Names

BoNT

Eligibility Criteria

Inclusion Criteria

1. Age 18 and over, male or female patient with (ET) involving at least their dominant hand, as diagnosed by a movement disorders neurologist.

2. Having bothersome hand tremor in dominant hand with a hand TRS ≥2

3. On stable medications during last 30 days prior to enrollment.

Exclusion Criteria

1. Presence of secondary causes of tremor, such as dystonia and parkinsonism

2. Any contraindication to botulinum toxin injections (e.g. motor neuron disease, neuromuscular junction disease, etc.)

3. History of surgical treatment for (ET).

4. Dementia as defined by DSM-V criteria

5. Patients with suboptimally treated depression and significant depressive symptoms as defined by a PHQ-9 score of ≥15 (PHQ-9 scores 1-4 Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression). Antidepressant medications, prescribed for depression or anxiety, will be allowed if the patient has been on a stable dose for at least 30 days.

6. Patients with suboptimally treated anxiety and significant anxiety symptoms as defined by a GAD-7 score of ≥15 (GAD-7 scores 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety). Anti-anxiety medications, prescribed for anxiety, will be allowed if the patient has been on a stable dose for at least 30 days.

7. Significant renal, hepatic, cardiac and thyroid disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hubert Fernandez, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15-1519

Identifier Type: -

Identifier Source: org_study_id