CD-PROBE: Cervical Dystonia Patient Reg… | Clinical Trial

Key information

Conditions

Cervical Dystonia Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Sex eligibility

All sexes

Study type

Observational

Primary location

Springfield, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention was administered as part of the study.

Primary outcomes

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score

Time frame: 4-6 weeks after treatment 3 (Up to 104.3 weeks)

TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 subscales comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.

Secondary outcomes

Percentage of Participants With Cervical Dystonia (CD) Severity Mild

Time frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)

The physician assessed the patient's severity of CD using a 3-point scale: mild, moderate or severe. The percentage of participants with CD Severity Mild is reported.
Percentage of Participants With Improvement in Clinicians Global Impression of Change

Time frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)

The physician evaluated the change in the patient's present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse. The percentage of participants where the physician's response was: 1=very much improved, 2=much improved or 3=minimally improved is reported.
Percentage of Participants With Improvement in the Patient Global Impression of Change

Time frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)

The patient evaluated the change in their present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse. The percentage of participants with responses: 1=very much improved, 2=much improved or 3=minimally improved is reported.
Pain Numeric Rating Scale Score

Time frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)

Patients rated their level of pain during the past 24 hours using an 11-point scale where: 0=no pain to 10= pain as bad as you can imagine. A lower number score indicated a lower amount of pain.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Feb 4, 2009
Registry last updated: Jul 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed