Objective: Here, we present the eligibility criteria and study design of ELATE, a Phase 2b clinical trial evaluating the safety and efficacy of onabotA compared to placebo for the treatment of adult upper limb essential tremor (ULET).

Background: Essential tremor (ET) is characterized by rhythmic oscillation of agonist and antagonist muscle groups and affects ~25–60 million individuals worldwide.^1,2 Receiving an accurate diagnosis usually takes longer than 3 years. Patients and healthcare providers remain unsatisfied due to poor safety and efficacy of current oral treatment options.^3,4,5 OnabotulinumtoxinA (onabotA) may alleviate tremor symptoms by locally preventing or lessening muscle contractions in the upper extremities^6-8.

Method: ELATE is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in adults with ULET. Key inclusion criteria include a diagnosis of ET according to modified Tremor Research Group (TRG) criteria in adults ages 18-80, Tremor Disability Scale-Revised (TREDS-R) score ≥3 on any of the 7 unilateral items, The Essential Tremor Rating Assessment Scale Activities of Daily Living (TETRAS ADL) score ≥3 on any of the 5 unilateral items, and either TETRAS UL Score of >2 or TETRAS Archimedes spiral task score of >2 in the dominant limb. Key exclusion criteria include any uncontrolled significant medical condition and any disorder that may worsen with exposure to onabotA.

The primary efficacy measure is the change in TREDS-R total score across 7 unilateral items from baseline to week 18. Secondary outcome measures include various tremor assessment scales and global impression of severity scores (Table 1).

Participants will be assigned to one of four regimens, involving onabotA or placebo administered unilaterally or bilaterally. The study consists of two treatment cycles of unilateral onabotA or placebo during the double-blind placebo-controlled phase, followed by a single unilateral or bilateral treatment of onabotA.

The study seeks to enroll 174 participants across ~40 sites in the United States and Canada.

Results: Enrollment is expected to be completed in 2024.

Conclusion: Results from the ELATE study could provide valuable insights into the effectiveness and safety of onabotA for ULET. Local administration of onabotA may offer a more favorable risk-benefit profile compared to currently available oral therapies.

Table 1: Study Measures

Table 2: Study Schematic

References: 1. Crawford P., Zimmerman EE., Am Fam Physician. 2018;97(3):180–186; 2.

2. Song P., Zhang Y., Zha M., Yang Q., Ye X., Yi Qian., Rudan I. The global prevalence of essential tremor, with emphasis on age and sex: A meta-analysis. J Glob Health. 2021; 11:04028, 202.

3. Amlang CJ, et al. Front Neurol. 2020;11:172

4. Zesiewicz, TA., Elble RJ., Louis ED., Gronseth GS., Ondo WG., Dewey RB., Okun MS., Sullivan KL., Weiner WJ. Evidence-based guideline update: Treatment of essential tremor. 2011; Neurology 77:1752-5.

5. Welton T., Cardoso F., Carr JA., Chan L., Deuschl G., Jankovic J., Tan E. Essential Tremor. 2021; J Glob Health 11:04028.

6. Brin MF., Lyons KE., Adler Ch., Caviness JN., Comella CL., Dubinsky RM., Friedman JH., Manyam BV., SL Matsumoto., Pullman SL., Rajput Ah., Sethi KD., Tanner., C., Koller WC. A randomized, double masked, controlled trial of botulinum toxin type A in essential hand tremor. 2001; Neurology 56:1523-8.

7. Jankovic J., Schwartz K., Clemence W., Aswad A., Mordaunt J. A randomized, double-blind, placebo-controlled study to evaluate botulinum toxin type A in essential hand tremor. 1996; Mov Disord 11:250-6.

8. Warrick P., Dromey C., Irish JC., Durkin L., Pakiam A., Lang A. Botulinum toxin for essential tremor of the voice with multiple anatomical sites of tremor: A crossover design study of unilateral versus bilateral injection. 2000; Laryngoscope 110:1366-74.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-phase-2b-multicenter-randomized-double-blind-placebo-controlled-study-of-onabotulinumtoxina-for-the-treatment-of-upper-limb-essential-tremor-elate-trial/