At a glance
ClinicalIndex Comparison Record- ✓Age 20-74 years at baseline.
- ✓Dystonia in at least 2 cervical muscles (sternocleidomastoid, scalenus complex, trapezius, levator scapulae, splenius capitis, or semispinalis capitis).
- ✓Persistent cervical dystonia symptoms for ≥1 year.
- ✓Body weight ≥40 kg.
- ✕Primary botulinum toxin resistance (no-responders); previous responders who later became non-responders may be included.
- ✕Significantly narrowed passive neck range of motion due to cervical contracture or spondylosis.
- ✕Pure retrocollis or anterocollis symptoms only.
- ✕Botulinum toxin treatment within 4 months prior to study or evidence of carry-over effect at baseline.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Dose-Response, Study of E2014 in Patients WIth Spasmodic Torticollis
In Brief
A Phase 2 clinical trial evaluating BOTULINUM TOXIN TYPE B for Cervical Dystonia and Spasmodic Torticollis. Completed, enrolled 133 participants across 21 sites.
Detailed Summary
To evaluate efficacy and safety of E2014 (2500U, 5000U, 10000U, placebo) in a multicenter, randomized, double-blind, parallel group comparative study by intramuscularly administering to patients with spasmodic torticollis. Primary endpoint for efficacy evaluation is changes in TWSTRS total scores from baseline measured at Week 4 and the clinical recommended dose will be examined with Williams multiple comparison. For safety evaluation, an inter group comparison (active drug and placebo) will be performed mainly focusing on incidence of adverse events, adverse drug reactions, and abnormal changes in laboratory parameters.