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BOTOX formulation comparison in cervical dystonia
2007-004530-16Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2007
- Countries
- 1
- Sponsor
- Allergan
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- cervical dystonia (CD)
01
Overview
Phase 2, randomised, double-blind trial of botulinum toxin type A in cervical dystonia (CD) (3 arms), sponsored by Allergan. Primary endpoints: Primary efficacy endpoint and TWSTRS total score characteristics. Started Oct 2007; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
BOTOX formulation 9060X
Double-blind BOTOX formulation 9060X during the controlled phase, then blinded active extension.
BOTOX formulation 9525X
Double-blind BOTOX formulation 9525X during the controlled phase, then blinded active extension.
Placebo
Double-blind placebo during the controlled phase, followed by blinded active treatment extension.
03
Who it enrols
Adults aged 18 to 75 years with clinically diagnosed idiopathic cervical dystonia, or segmental/generalized dystonia in which cervical dystonia is the predominant feature, and who were botulinum toxin-naive for any indication. Patients with uncontrolled medical conditions other than the target condition were excluded.
04
Endpoints
Primary
Primary efficacy endpoint
TWSTRS total score characteristics
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