Efficacy and Safety of Two Different Botulinum Toxin Type A Treatments for Moderate to Severe Cervical Dystonia

Kísérleti: BOTOX®

Botulinum toxin type A (BOTOX®)

Biológiai: A típusú botulinum toxin

200 egység az 1. látogatáskor (1. nap)

Más nevek:

• BOTOX®

Biológiai: botulinum toxin type A

500 Units at Visit 1 (Day 1)

Más nevek:

• Dysport®

Aktív összehasonlító: Dysport®

Botulinum toxin type A (Dysport®)

Biológiai: A típusú botulinum toxin

200 egység az 1. látogatáskor (1. nap)

Más nevek:

• BOTOX®

Biológiai: botulinum toxin type A

500 Units at Visit 1 (Day 1)

Más nevek:

• Dysport®

Duration of Treatment Benefit

Duration of treatment benefit was measured as the time (days) from Baseline until patients had a loss of therapeutic benefit, as defined by the achievement of their Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) [loss of 80% of benefit].

A beteg vizuális analóg fájdalomértékelése a 4. héten

A betegeknek vizuális analóg skála segítségével kellett felmérniük fájdalmukat az adott vizit során tapasztalt fájdalomérzékelésük alapján. Ez a skála egy 100 mm-es vonalból állt, és a betegeket arra utasították, hogy tegyenek egy jelet a vonalra arra a pontra, amely a legjobban leírja: „Mekkora fájdalmai vannak jelenleg”. A magasabb pontszámok nagyobb fájdalomintenzitást jeleztek: 0 azt jelezte, hogy „nincs fájdalom”, 100 pedig „a lehető legrosszabb fájdalmat”.

Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) at Week 4

The TDTS was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score representing a loss of 80% of the treatment benefit at Week 4. The TDTS is calculated from the TWSTRS score and ranges from 0 (least symptoms) to 68 (worst symptoms). The TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms).

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4

The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.

Global Assessment of Benefit by Patient at Week 4

Patient evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater)'.

Global Assessment of Benefit by Physician at Week 4

Physician evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater)'.

Physician Assessment of Cervical Dystonia Severity at Week 4

Physician assessment of cervical dystonia severity. The rating was assessed on a scale of 0 to 10, with higher scores denoting greater severity: 0 represented 'No evidence of dystonia' and 10 represented 'Worst cervical dystonia ever'

Physician Comparison of Benefit to Previous Injections at Week 20

Physicians assessed the improvement in cervical dystonia after the study treatment compared to previous treatment(s) for each patient. Physicians were required to answer "How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?". The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'.

Patient Comparison of Benefit to Previous Injections at Week 20

Patients assessed the improvement in cervical dystonia after receiving the study treatment compared to previous treatment(s). Patients were required to answer "How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?". The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'.

Patient Assessment of Need for Retreatment at Week 4

Patients were queried regarding their need for another injection of botulinum toxin type A for cervical dystonia. Patients were required to answer "How would you rate your need for another injection of botulinum toxin type A for cervical dystonia using the following scale?". The response options included 'absolutely requires injection', 'very much requires injection', 'somewhat requires injection', and 'does not require injection'.