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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01814774
Other study ID # TRU2011
Secondary ID
Status Completed
Phase N/A
First received March 18, 2013
Last updated June 4, 2014
Start date January 2013
Est. completion date July 2013

Study information

Verified date June 2014
Source Allergan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardNorway: Ethics Committee
Study type Observational

Clinical Trial Summary

This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at least 2 years

- treatment with Xeomin® and BOTOX® for at least 1 year each

Exclusion Criteria:

- having a neuromuscular junction transmission disorder or taking any medications that could affect neuromuscular junction transmission

- previous surgical procedure involving bone or muscle for the management of cervical dystonia or blepharospasm

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Intervention

Other:
No Intervention
No treatment (intervention) was administered.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Countries where clinical trial is conducted

Norway,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose of Botulinum Toxin Used to Treat Cervical Dystonia The average dose of botulinum toxin received per patient per year was calculated. 2 Years No
Primary Dose of Botulinum Toxin Used to Treat Blepharospasm The average dose of botulinum toxin received per patient per year was calculated. 2 Years No
Secondary Number of Participants With Adverse Events An Adverse Event was any unfavorable and unintended sign, symptom, or disease documented in the medical chart that occurred after treatment with botulinum toxin, or pre-existing conditions that worsened during the retrospective period. 2 Years No
Secondary Botulinum Toxin Inter-injection Interval Injection-interval was the time in weeks between injections of botulinum toxin. 2 Years No
See also
  Status Clinical Trial Phase
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Withdrawn NCT02180139 - tDCS in Cervical Dystonia N/A
Completed NCT00541905 - Daily Dystonia Practice - A Trial to Investigate NT 201, the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Cervical Dystonia Phase 4
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Completed NCT05103202 - Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin
Terminated NCT00760318 - Keppra for Cervical Dystonia Phase 2
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Completed NCT04171258 - Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia Phase 1
Completed NCT04849988 - A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia Phase 2