N/A
Completed N=20
Comparison of Botulinum Toxin Injections in Forearm FLexor Plus EXtensor Muscles vs. Flexor Muscles Alone for Treatment of Essential Hand Tremor(FLEX-D ET)
Source: ClinicalTrials.gov NCT02909907 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: 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
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).
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 | — |
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
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. Informational only — not medical advice.