Conditions: Cervical Dystonia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 242
Healthy volunteers: no

Brief summary:
Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and placebo.

Detailed description:

Arms:
arm 1: Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. arm 2: Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. arm 3: Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments. arm 4: Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.

Interventions: intervention 1: botulinum toxin type A intervention 2: botulinum toxin type A Formulation 2 intervention 3: Normal Saline
Intervention descriptions: intervention 1: Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. intervention 2: Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. intervention 3: Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.

Protocol document: