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

NeuroTherapia, Inc.

Status: Completed

Conditions: Essential Tremor

Treatments: Drug: Botulinum toxin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02909907

15-1519

Details and patient eligibility

About

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).

Full 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).

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups

150 units of abobotulinumtoxinA

Experimental group

Description:

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)

Treatment:

Drug: Botulinum toxin

Other: Placebo

75 units of abobotulinumtoxinA

Experimental group

Description:

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

Treatment:

Drug: Botulinum toxin