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

NCT02909907 | Completed Results

• 1 other identifier: 15-1519
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

• Difference in the 6 Week Post Injection Patient Global Impression of Improvement Scale (PGIS) Between Flexors Along and Flexors Plus Extensors Groups.

  6 weeks post injection Clinician Global Impression if improvement Scale (CGIS) Assessment of improvement graded by the patient on a -4 to +4 scale * -4 = severe worsening * 0 = no change * +4 = complete abolishment of symptoms Higher scores represent better outcome.

  6 weeks

Secondary Outcomes (8)

• Difference in Tremor Rating Scale Score (TSR)Change From Baseline to Week 6 Between Flexors Alone and Flexors Plus Extensors Groups.

  Baseline and 6 weeks

• Difference in the 6 Week Post Injection Clinician Global Impression of Improvement Scale (CGIS) Between Flexors Along and Flexors Plus Extensors Groups.

  6 weeks

• 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.

  Baseline and 6 weeks

• Difference in the Post Injection Grip Strength Change Between Flexor Only Group and Flexor and Extensors Group at 6 Weeks.

  6 weeks

• 12 Weeks Post Injection Tremor Rating Scale for Flexors Group and Flexors Plus Extensors Group.

  12 weeks

Study Arms (2)

150 units of abobotulinumtoxinA

EXPERIMENTAL

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)

Drug: Botulinum toxin; Other: Placebo

75 units of abobotulinumtoxinA

EXPERIMENTAL

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

Drug: Botulinum toxin

Interventions

Botulinum toxin DRUG

Botulinum injections into dominant upper extremity using protocol outlined above.

Also known as: BoNT

150 units of abobotulinumtoxinA; 75 units of abobotulinumtoxinA

Placebo OTHER

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

150 units of abobotulinumtoxinA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Essential Tremor

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Hubert H Fernandez
• Organization: Cleveland Clinic Foundation

FERNANH@ccf.org

2164451108

Study Officials

• Hubert Fernandez, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: September 21, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 28, 2018
• Last Updated: May 8, 2019
• Results First Posted: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)