Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia

Allergan

Status and phase: Completed; Phase 2

Conditions: Cervical Dystonia

Treatments: Biological: botulinum toxin type A Formulation 2; Biological: botulinum toxin type A; Drug: Normal Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00564681

191622-090

Details and patient eligibility

About

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.

Enrollment: 242 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of cervical dystonia

Exclusion criteria

• Current or previous botulinum toxin treatment of any type for any condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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242 participants in 4 patient groups

botulinum toxin Type A

Active Comparator group

Description:

Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.

Treatment:

Biological: botulinum toxin type A

botulinum toxin Type A Formulation 2

Active Comparator group

Description:

Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.

Treatment:

Biological: botulinum toxin type A Formulation 2

Placebo (Normal Saline) / botulinum toxin Type A

Other group

Description:

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.

Treatment:

Drug: Normal Saline

Biological: botulinum toxin type A

Placebo (Normal Saline) / botulinum toxin Type A Formulation 2

Other group

Description:

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.

Treatment:

Biological: botulinum toxin type A Formulation 2

Drug: Normal Saline