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Trial record 77 of 116 for:    cervical | "dopa-responsive dystonia" OR "Dystonia"

Efficacy and Safety of Two Different Botulinum Toxin Type A Treatments for Moderate to Severe Cervical Dystonia

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ClinicalTrials.gov Identifier: NCT00432341
Recruitment Status : Terminated (Study was terminated early due to difficulties with patient recruitment)
First Posted : February 7, 2007
Results First Posted : December 16, 2011
Last Update Posted : December 16, 2011
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Spasmodic Torticollis
Intervention Biological: botulinum toxin type A
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BOTOX® Dysport®
Hide Arm/Group Description Botulinum toxin type A (BOTOX®) Botulinum toxin type A (Dysport®)
Period Title: Overall Study
Started 24 30
Completed 24 30
Not Completed 0 0
Arm/Group Title BOTOX® Dysport® Total
Hide Arm/Group Description Botulinum toxin type A (BOTOX®) Botulinum toxin type A (Dysport®) Total of all reporting groups
Overall Number of Baseline Participants 24 30 54
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 30 participants 54 participants
42.0  (13.1) 49.9  (12.6) 46.4  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 30 participants 54 participants
Female
7
  29.2%
12
  40.0%
19
  35.2%
Male
17
  70.8%
18
  60.0%
35
  64.8%
1.Primary Outcome
Title Duration of Treatment Benefit
Hide Description Duration of treatment benefit was measured as the time (days) from Baseline until patients had a loss of therapeutic benefit, as defined by the achievement of their Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) [loss of 80% of benefit].
Time Frame 20 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.
Arm/Group Title BOTOX® Dysport®
Hide Arm/Group Description:
Botulinum toxin type A (BOTOX®)
Botulinum toxin type A (Dysport®)
Overall Number of Participants Analyzed 24 30
Median (95% Confidence Interval)
Unit of Measure: Days
112.5
(102.0 to 126.0)
107.0
(102.0 to 118.0)
2.Secondary Outcome
Title Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) at Week 4
Hide Description The TDTS was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score representing a loss of 80% of the treatment benefit at Week 4. The TDTS is calculated from the TWSTRS score and ranges from 0 (least symptoms) to 68 (worst symptoms). The TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms).
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.
Arm/Group Title BOTOX® Dysport®
Hide Arm/Group Description:
Botulinum toxin type A (BOTOX®)
Botulinum toxin type A (Dysport®)
Overall Number of Participants Analyzed 24 30
Median (Full Range)
Unit of Measure: Scores on a Scale
37.0
(16 to 56)
41.0
(26 to 69)
3.Secondary Outcome
Title Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4
Hide Description The 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 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.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.
Arm/Group Title BOTOX® Dysport®
Hide Arm/Group Description:
Botulinum toxin type A (BOTOX®)
Botulinum toxin type A (Dysport®)
Overall Number of Participants Analyzed 24 30
Median (Full Range)
Unit of Measure: Scores on a Scale
Baseline
42.0
(17 to 63)
43.5
(30 to 73)
Week 4
26.0
(10 to 47)
27.0
(11 to 52)
4.Secondary Outcome
Title Global Assessment of Benefit by Patient at Week 4
Hide Description Patient evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater)'.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.
Arm/Group Title BOTOX® Dysport®
Hide Arm/Group Description:
Botulinum toxin type A (BOTOX®)
Botulinum toxin type A (Dysport®)
Overall Number of Participants Analyzed 24 30
Median (Full Range)
Unit of Measure: Units on a Scale
2.0
(0 to 4)
2.0
(-3 to 3)
5.Secondary Outcome
Title Global Assessment of Benefit by Physician at Week 4
Hide Description Physician evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater)'.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.
Arm/Group Title BOTOX® Dysport®
Hide Arm/Group Description:
Botulinum toxin type A (BOTOX®)
Botulinum toxin type A (Dysport®)
Overall Number of Participants Analyzed 24 30
Median (Full Range)
Unit of Measure: Units on a Scale
2.0
(1 to 4)
2.0
(1 to 3)
6.Secondary Outcome
Title Physician Assessment of Cervical Dystonia Severity at Week 4
Hide Description Physician assessment of cervical dystonia severity. The rating was assessed on a scale of 0 to 10, with higher scores denoting greater severity: 0 represented 'No evidence of dystonia' and 10 represented 'Worst cervical dystonia ever'
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure.
Arm/Group Title BOTOX® Dysport®
Hide Arm/Group Description:
Botulinum toxin type A (BOTOX®)
Botulinum toxin type A (Dysport®)
Overall Number of Participants Analyzed 24 30
Median (Full Range)
Unit of Measure: Units on a Scale
Baseline
7.0
(4 to 9)
8.0
(4 to 9)
Week 4
4.0
(2 to 6)
4.0
(1 to 7)
7.Secondary Outcome
Title Physician Comparison of Benefit to Previous Injections at Week 20
Hide Description Physicians assessed the improvement in cervical dystonia after the study treatment compared to previous treatment(s) for each patient. Physicians were required to answer "How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?". The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at this time point are included.
Arm/Group Title BOTOX® Dysport®
Hide Arm/Group Description:
Botulinum toxin type A (BOTOX®)
Botulinum toxin type A (Dysport®)
Overall Number of Participants Analyzed 18 24
Measure Type: Number
Unit of Measure: Number of Responses
Much Worse 0 0
Worse 0 1
Somewhat Worse 0 3
Same as Previous 13 13
Somewhat Better 4 5
Better 0 1
Much Better 1 1
8.Secondary Outcome
Title Patient Comparison of Benefit to Previous Injections at Week 20
Hide Description Patients assessed the improvement in cervical dystonia after receiving the study treatment compared to previous treatment(s). Patients were required to answer "How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?". The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at this time point are included.
Arm/Group Title BOTOX® Dysport®
Hide Arm/Group Description:
Botulinum toxin type A (BOTOX®)
Botulinum toxin type A (Dysport®)
Overall Number of Participants Analyzed 19 21
Measure Type: Number
Unit of Measure: Number of Responses
Much Worse 0 0
Worse 0 1
Somewhat Worse 0 1
Same as Previous 8 11
Somewhat Better 8 4
Better 0 0
Much Better 3 4
9.Secondary Outcome
Title Patient Visual Analog Assessment of Pain at Week 4
Hide Description Patients were required to assess their pain using a Visual Analog Scale in reference to their current perception of pain at that visit. This scale consisted of a line measuring 100 mm, and patients were instructed to put a mark on the line at the point that best described 'How much pain you are having right now'. Higher scores denoted higher pain intensity: 0 indicated 'No pain' and 100 indicated 'Worst possible pain'.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure.
Arm/Group Title BOTOX® Dysport®
Hide Arm/Group Description:
Botulinum toxin type A (BOTOX®)
Botulinum toxin type A (Dysport®)
Overall Number of Participants Analyzed 24 30
Median (Full Range)
Unit of Measure: Units on a Scale
Baseline
49.5
(0 to 81)
52.0
(0 to 100)
Week 4
20.5
(0 to 58)
28.0
(0 to 87)
10.Secondary Outcome
Title Patient Assessment of Need for Retreatment at Week 4
Hide Description Patients were queried regarding their need for another injection of botulinum toxin type A for cervical dystonia. Patients were required to answer "How would you rate your need for another injection of botulinum toxin type A for cervical dystonia using the following scale?". The response options included 'absolutely requires injection', 'very much requires injection', 'somewhat requires injection', and 'does not require injection'.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at the time points are included.
Arm/Group Title BOTOX® Dysport®
Hide Arm/Group Description:
Botulinum toxin type A (BOTOX®)
Botulinum toxin type A (Dysport®)
Overall Number of Participants Analyzed 23 29
Measure Type: Number
Unit of Measure: Number of Responses
Absolutely requires injection at Baseline 19 24
Very much requires injection at Baseline 5 5
Somewhat requires injection at Baseline 0 0
Does not require injection at Baseline 0 0
Absolutely requires injection at Week 4 1 4
Very much requires injection at Week 4 7 5
Somewhat requires injection at Week 4 4 3
Does not require injection at Week 4 11 17
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BOTOX® Dysport®
Hide Arm/Group Description Botulinum toxin type A (BOTOX®) Botulinum toxin type A (Dysport®)
All-Cause Mortality
BOTOX® Dysport®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BOTOX® Dysport®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BOTOX® Dysport®
Affected / at Risk (%) Affected / at Risk (%)
Total   12/24 (50.00%)   12/30 (40.00%) 
Gastrointestinal disorders     
Dry Mouth * 1  2/24 (8.33%)  2/30 (6.67%) 
Dysphagia * 1  4/24 (16.67%)  1/30 (3.33%) 
General disorders     
Fatigue * 1  1/24 (4.17%)  3/30 (10.00%) 
Musculoskeletal and connective tissue disorders     
Muscular Weakness * 1  1/24 (4.17%)  2/30 (6.67%) 
Neck Pain * 1  4/24 (16.67%)  2/30 (6.67%) 
Respiratory, thoracic and mediastinal disorders     
Choking * 1  0/24 (0.00%)  2/30 (6.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
The study was terminated early due to difficulties with patient recruitment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release for a period that is not less than 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication.
Results Point of Contact
Name/Title: Vice President Medical Affairs
Organization: Allergan, Inc.
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00432341     History of Changes
Other Study ID Numbers: MedAff-BTX-0615
First Submitted: February 5, 2007
First Posted: February 7, 2007
Results First Submitted: November 14, 2011
Results First Posted: December 16, 2011
Last Update Posted: December 16, 2011