The Need for Flexibility and Patient-Centered Approaches in Clinical Trials for Cervical Dystonia: Anna Castagna, MD

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"If a patient has difficulties after one treatment they must be reassured that it is possible to be reinjected when they perceive the wearing off effect, even if it is before the considered time."

Patients with cervical dystonia treated with botulinum toxin, a first-line therapy for this condition, typically require injections every 3 to 4 months. The consistency of botulinum toxin's effect is important for maintaining the patients' quality of life, as it helps prevent fluctuations in symptom control between injections. However, there is currently no standardized method for clinicians to assess the duration of botulinum toxin's effect in patients with cervical dystonia in a clinical setting.

A recent scoping review performed by lead author Anna Castagna, MD, and colleagues summarized available evidence from phase 3 clinical trials assessing botulinum toxin in cervical dystonia and interpretation of the reported duration of its effect. In the review, studies showed that clinical trial outcomes in cervical dystonia were not assessed objectively, and did not prioritize the needs of patients or focus on factors that impacted their daily living activities and quality of life. Authors therefore noted that there is a need for better evidence and consistency of reports for duration of effect for botulinum toxin in cervical dystonia to guide providers on when reinjection is likely to be essential.₁

These findings were presented at the 3rd Annual Advanced Therapeutics in Movement and Related Disorders (ATMRD) Congress, held by the PMD Alliance from June 22-25, 2024, by Castagna, a consultant neurologist at Fondazione Don Carlo Gnocchi ONLUS in Milan, Italy. Recently, Castagna sat down with NeurologyLive^® to discuss how the integration of patient-centered measurement scales can improve the outcomes of clinical trials for cervical dystonia. She also talked about the potential benefits and challenges of using mobile apps to monitor the effectiveness and duration of cervical dystonia treatments. Moreover, Castagna spoke about how the flexibility in reinjection schedules may impact patient outcomes and overall treatment effectiveness in real-life settings.

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REFERENCES
1. Castagna A, Jinnah HA, Albanese A. Duration of botulinum toxin efficacy in cervical dystonia clinical trials: A scoping review. Parkinsonism Relat Disord. 2024;125:107011. doi:10.1016/j.parkreldis.2024.107011