We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    A-TL-52120-170
Previous Study | Return to List | Next Study

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
  Purpose
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).

Condition Intervention Phase
Cervical Dystonia Drug: Dysport® Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 112
Study Start Date: March 2013
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dysport®
Dysport®, up to 500 units (U)/vial using 2mL dilution
Drug: Dysport®
Dysport® (intramuscular injection), Up to 500 units (U)/vial using 2mL dilution, 3 treatment cycles
Other Name: AbobotulinumtoxinA (non-proprietary name)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753336


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Movement Disorders Center of Arizona, LLC
Scottsdale, Arizona, United States, 85258
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
East Bay Physician's Group
Berkeley, California, United States, 94705
Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
Loma Linda University Healthcare, Department of Neurology
Loma Linda, California, United States, 92354
USC Keck School of Medicine
Los Angeles, California, United States, 90033
Sutter Cancer Center
Sacramento, California, United States, 95816
UC Davis Medical Center
Sacramento, California, United States, 95817
United States, Colorado
Advanced Neurosciences Research
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Associated Neurologist of Southern CT, PC
Fairfield, Connecticut, United States, 06824
Yale Medical Group, Yale University
New Haven, Connecticut, United States, 06520
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States, 32607
Emerald Coast Center for Neurological Disorders
Pensacola, Florida, United States, 32514
Parkinson's Treatment Center of SW Florida
Port Charlotte, Florida, United States, 33980
USF HealthParkinson's Disease and Movement Disorders Center
Tampa, Florida, United States, 33613
Guilford Neurologic Associates
West Palm Beach, Florida, United States, 33407
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
NeuroTrials Research Inc.
Atlanta, Georgia, United States, 30342
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Kansas
Kansas City Bone & Joint Clinic
Kansas City, Kansas, United States, 66211
International Clinical Research Institute
Overland Park, Kansas, United States, 66210
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Minnesota
Rehabilitation Consultants, PA
Eagan, Minnesota, United States, 55121
United States, New Jersey
University of Medicine and Dentistry of New Jersey
Stratford, New Jersey, United States, 08084
Atlantic Neuroscience Institute
Summit, New Jersey, United States, 07901
United States, New York
Kingston Neurological Associates
Kingston, New York, United States, 12401
The Ichan School of Medicine at Mount Sinai
New York, New York, United States, 10029
Island Neurological Associates
Plainview, New York, United States, 11803
United States, North Carolina
Guilford Neurologic Associates; Cone Health Medical Group
Greensboro, North Carolina, United States, 27405
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati Physicians Company, LLC
Cincinnati, Ohio, United States, 45267
United States, Oregon
OHSU Center for Health and Healing
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Hershey Neurology
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Coastal Neurology, PA
Port Royal, South Carolina, United States, 29935
United States, Texas
North Texas Movement Disorders Institute
Bedford, Texas, United States, 76201
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
United States, Washington
Puget Sound Neurology
Tacoma, Washington, United States, 98409
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Medical Director Neurology, M.D. Ipsen
  More Information

Additional Information:
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01753336     History of Changes
Other Study ID Numbers: A-TL-52120-170
First Submitted: December 17, 2012
First Posted: December 20, 2012
Results First Submitted: January 12, 2017
Results First Posted: May 4, 2017
Last Update Posted: May 4, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
abobotulinumtoxinA
Botulinum Toxins, Type A
onabotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents