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CD-PROBE: Cervical Dystonia Patient Registry for the Observation of Botulinum Toxin Type A Efficacy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00836017
First received: February 2, 2009
Last updated: October 4, 2012
Last verified: October 2012
History of Changes
  Purpose

This study is an observational trial which will measure the efficacy of botulinum toxin type A in treating Cervical Dystonia.


Condition Intervention
Cervical Dystonia
 Biological: Botulinum toxin type A

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Botox Dystonia
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: Baseline, at time of injection 1, 2, 3, and 4-6 weeks after injection 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CD Severity [ Time Frame: Baseline, at time of injection 1, 2, 3, and 4-6 weeks after injection 3 ] [ Designated as safety issue: No ]
  • Clinicians Global Impression of Change [ Time Frame: At time of injection 2 and 3, and 4-6 weeks after injection 3 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: At time of injection 2 and 3, and 4-6 weeks after injections 1, 2, and 3 ] [ Designated as safety issue: No ]
  • Pain Numeric Rating Scale [ Time Frame: Baseline, at time of injection, 1, 2, 3 and 4-6 weeks after injections 1, 2 and 3 ] [ Designated as safety issue: No ]

Enrollment: 1046
Study Start Date: January 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients receiving botulinum toxin type A
Patients receiving botulinum toxin type A. Treatment not directed by protocol. Directed by treated physician.
 Biological: Botulinum toxin type A
Treatment not directed by protocol. Directed by treated physician.
Other Name: BOTOX®

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Cervical Dystonia whom are being treated with botulinum toxin type A

Criteria

Inclusion Criteria:

  • Diagnosed with Cervical Dystonia
  • Candidate for botulinum toxin type A therapy
  • New to physician's practice, and/or new to botulinum toxin type A therapy, or has not been injected with botulinum toxin type A for at least 16 weeks as a participant in another clinical trial investigating botulinum toxin type A for cervical dystonia
  • Able to follow study instructions and complete study activities

Exclusion Criteria:

  • Patients undergoing elective surgery during the trial period
  • Females who are pregnant, nursing, or planning a pregnancy
  • History of poor cooperation or compliance with medical treatment or unreliability
  • Any condition or situation in which, in the investigator's opinion, places the patient at significant risk, could confound the study data, or may interfere with the patient's participation in the study, including but not limited to unstable medical conditions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836017

Locations
United States, Colorado
Greeley, Colorado, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided by Allergan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00836017     History of Changes
Other Study ID Numbers: MedAff BTX-0718
Study First Received: February 2, 2009
Last Updated: October 4, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
 Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013