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Trial record 1 of 1 for:    A-TL-52120-170
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Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01753336
First Posted: December 20, 2012
Last Update Posted: May 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ipsen
December 17, 2012
December 20, 2012
January 12, 2017
May 4, 2017
May 4, 2017
March 2013
October 2015   (Final data collection date for primary outcome measure)
TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. [ Time Frame: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) ]
Mean TWSTRS total scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.
Change from treatment cycle baseline (defined as Day 1 in each cycle) in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score [ Time Frame: Week 4 and Week 12 visits ]
Complete list of historical versions of study NCT01753336 on ClinicalTrials.gov Archive Site
  • TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. [ Time Frame: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) ]
    The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had received placebo. Mean TWSTRS total scores for pretreatment baseline and for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from pretreatment baseline scores at Week 4 and Week 12 of each treatment cycle are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle.
  • Treatment Response in Treatment Cycle 3 Week 4. [ Time Frame: Week 4 Treatment Cycle 3 ]
    Treatment response was defined as a reduction in the TWSTRS total score of at least 30% from pretreatment baseline to the Week 4 visit in Treatment Cycle 3. The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had previously received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had previously received placebo. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle. The proportion (percentage) of subjects who were treatment responders at Week 4 of Treatment Cycle 3 are presented.
  • TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. [ Time Frame: Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each) ]
    Mean TWSTRS severity subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS severity subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for treatment cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The severity subscale gives a score from 0 to 35, with higher values indicating a worse outcome of physical findings of CD. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.
  • TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. [ Time Frame: Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each) ]
    Mean TWSTRS disability subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The disability subscale is a 6-item scale and each item is rated on a 6-point scale with higher values indicating the highest degree of disability. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.
  • TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3. [ Time Frame: Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each) ]
    Mean TWSTRS pain subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The pain subscale gives a score from 0 to 20, with higher values indicating greater pain experienced. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.
  • Change from baseline (defined as the measurement before Dysport treatment in Study 169) in TWSTRS total score [ Time Frame: Week 4 and Week 12 visits ]
  • Treatment response in Treatment Cycle 3 [ Time Frame: Baseline and Week 4 visit ]
    A treatment responder is defined as a subject who had at least a 30% reduction from baseline in the TWSTRS total score after treatment.
  • Change from treatment cycle baseline in TWSTRS severity subscale score [ Time Frame: Week 4 and Week 12 ]
  • Change from treatment cycle baseline in TWSTRS disability subscale score [ Time Frame: Week 4 and Week 12 ]
  • Change from treatment cycle baseline in TWSTRS pain subscale score [ Time Frame: Week 4 and Week 12 ]
Not Provided
Not Provided
 
Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia
A Phase IIIb, Prospective, Multicentre, Open-Label Extension Study To Assess Long Term Safety And Effectiveness Of Dysport® Using 2 mL Dilution In Adults With Cervical Dystonia
The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169).
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cervical Dystonia
Drug: Dysport®
Dysport® (intramuscular injection), Up to 500 units (U)/vial using 2mL dilution, 3 treatment cycles
Other Name: AbobotulinumtoxinA (non-proprietary name)
Experimental: Dysport®
Dysport®, up to 500 units (U)/vial using 2mL dilution
Intervention: Drug: Dysport®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
October 2015
October 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects enrolled in Study 169 that have no ongoing adverse events, which in the opinion of the Investigator are related to study treatment and that precludes them from receiving continuing therapy
  • Completed Study 169, or completed all study visits up to and including Week 4 and in the event of an early withdrawal after Week 4 have ≤15% reduction in TWSTRS total score at Week 4 compared to their baseline TWSTRS total score in the double-blind study, and in the Investigator's clinical judgment, would benefit from Dysport® for CD

Exclusion Criteria:

  • Diagnosis of pure retrocollis or pure anterocollis
  • Requirement for Botulinum Neurotoxin (BoNT) injection to site(s) for disorders other than CD and unable to avoid such treatment(s) for the duration of the study
  • Known hypersensitivity to BoNT or related compounds, or any component in the study drug formulation
  • Allergy to cow's milk protein
  • Myasthenia gravis, other disease of the neuromuscular junction or clinically significant, persistent neuromuscular weakness, or disease or symptoms that could interfere with the TWSTRS scoring
  • Total body weight <95 lbs (43.09 kg)
  • Previous phenol injections to the neck muscles
  • Previous myotomy or denervation surgery involving the neck or shoulder region or deep brain stimulation to treat CD
  • Cervical contracture that limited passive range of motion
  • Physiotherapy initiated <4 weeks before study entry or expected to be initiated during the study
  • Treatment with aminoglycoside antibiotics within 30 days prior to study treatment
  • Current or expected requirement for concomitant medication that could interfere with the evaluation of study treatment
  • Pregnant and/or lactating females
  • Females of childbearing potential with a positive prestudy urine pregnancy test (a positive urine pregnancy test could be confirmed by a serum pregnancy test at the discretion of the investigator) and subjects, or their partners, who did not agree to use adequate contraception (hormonal or barrier method of birth control) prior to injection of study treatment and for the duration of study participation. Nonchildbearing potential is defined as postmenopause for at least 1 year, surgical sterilisation at least 3 months before entering the study, or hysterectomy
  • Individuals who had family or employee relationship to study site staff or sponsor staff involved in the conduct of the study
  • Any medical condition that could, as judged by the investigator, compromise compliance with the objectives and procedures of this protocol or preclude the administration of BoNT, including swallowing and other respiratory abnormality.
  • Subjects who were unable and/or unwilling to comply fully with the protocol and the study instructions, as judged by the investigator
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01753336
A-TL-52120-170
No
Not Provided
Not Provided
Ipsen
Ipsen
Not Provided
Study Director: Medical Director Neurology, M.D. Ipsen
Ipsen
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP