N/A N=20 Randomized Double-blind Treatment

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

Essential Tremor

Bottom Line

View on ClinicalTrials.gov: NCT02909907 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcome: Primary: Difference in the 6 Week Post Injection Patient Global Impression of Improvement Scale (PGIS) Between Flexors Along and Flexors Plus Extensors Groups. — 1.2; 2.2 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Botulinum toxin (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Feb 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference in the 6 Week Post Injection Patient Global Impression of Improvement Scale (PGIS) Between Flexors Along and Flexors Plus Extensors Groups.	1.2; 2.2	—
SECONDARY Difference in Tremor Rating Scale Score (TSR)Change From Baseline to Week 6 Between Flexors Alone and Flexors Plus Extensors Groups.	-5; -5	—
SECONDARY Difference in the 6 Week Post Injection Clinician Global Impression of Improvement Scale (CGIS) Between Flexors Along and Flexors Plus Extensors Groups.	1; 3	—
SECONDARY Difference of the Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 6 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group.	1.1; -5.3	—
SECONDARY Difference in the Post Injection Grip Strength Change Between Flexor Only Group and Flexor and Extensors Group at 6 Weeks.	-6.2; -11	—
SECONDARY 12 Weeks Post Injection Tremor Rating Scale for Flexors Group and Flexors Plus Extensors Group.	6; 6	—
SECONDARY 12 Week Post Injection in Clinician Global Impression Scale-Improvement Subscale (CGIS)	3; 3	—
SECONDARY 12 Week Post Injection Patient Global Impression Scale-Improvement Subscale (PGIS)	1; 3	—
SECONDARY Difference of Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 12 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group.	-1.67; 0	—

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).

Eligibility Criteria

Inclusion Criteria

Age 18 and over, male or female patient with (ET) involving at least their dominant hand, as diagnosed by a movement disorders neurologist.
Having bothersome hand tremor in dominant hand with a hand TRS ≥2
On stable medications during last 30 days prior to enrollment.

Exclusion Criteria

Presence of secondary causes of tremor, such as dystonia and parkinsonism
Any contraindication to botulinum toxin injections (e.g. motor neuron disease, neuromuscular junction disease, etc.)
History of surgical treatment for (ET).
Dementia as defined by DSM-V criteria
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.
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.
Significant renal, hepatic, cardiac and thyroid disease

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Data sourced from ClinicalTrials.gov (NCT02909907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.