Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia
NCT ID: NCT00564681
Last Updated: 2016-01-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
242 participants
INTERVENTIONAL
2007-12-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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botulinum toxin Type A
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
botulinum toxin type A
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
botulinum toxin Type A Formulation 2
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
botulinum toxin type A Formulation 2
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Placebo (Normal Saline) / botulinum toxin Type A
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.
botulinum toxin type A
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Normal Saline
Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.
Placebo (Normal Saline) / botulinum toxin Type A Formulation 2
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.
botulinum toxin type A Formulation 2
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Normal Saline
Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.
Interventions
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botulinum toxin type A
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
botulinum toxin type A Formulation 2
Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
Normal Saline
Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Winston-Salem, North Carolina, United States
Halifax, Nova Scotia, Canada
Prague, , Czechia
Berlin, , Germany
Budapest, , Hungary
Mumbai, , India
Manila, , Philippines
Warsaw, , Poland
Moscow, , Russia
Belgrade, , Serbia
Singapore, , Singapore
Spisska Nova, , Slovakia
Cape Town, , South Africa
Tainan City, , Taiwan
Bangkok, , Thailand
Bristol, , United Kingdom
Countries
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Other Identifiers
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191622-090
Identifier Type: -
Identifier Source: org_study_id
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