Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia

NCT01753336 | Completed Phase 3 Results

• 1 other identifier: A-TL-52120-170
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 41

Brief Summary

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).

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

• TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.

  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.

  Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)

Secondary Outcomes (5)

• TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.

  Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)

• Treatment Response in Treatment Cycle 3 Week 4.

  Week 4 Treatment Cycle 3

• TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.

  Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)

• TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.

  Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)

• TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.

  Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)

Study Arms (1)

Dysport®

EXPERIMENTAL

Dysport®, up to 500 units (U)/vial using 2mL dilution

Biological: Botulinum toxin type A

Interventions

Botulinum toxin type A BIOLOGICAL

Dysport® (intramuscular injection), Up to 500 units (U)/vial using 2mL dilution, 3 treatment cycles

Also known as: AbobotulinumtoxinA (Dysport®)

Dysport®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (41)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Movement Disorders Center of Arizona, LLC

Scottsdale, Arizona, 85258, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

East Bay Physician's Group

Berkeley, California, 94705, United States

Location

Parkinson's and Movement Disorder Institute

Fountain Valley, California, 92708, United States

Location

Loma Linda University Healthcare, Department of Neurology

Loma Linda, California, 92354, United States

Location

USC Keck School of Medicine

Los Angeles, California, 90033, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Advanced Neurosciences Research

Fort Collins, Colorado, 80528, United States

Location

Associated Neurologist of Southern CT, PC

Fairfield, Connecticut, 06824, United States

Location

Yale Medical Group, Yale University

New Haven, Connecticut, 06520, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

University of Florida Center for Movement Disorders and Neurorestoration

Gainesville, Florida, 32607, United States

Location

Emerald Coast Center for Neurological Disorders

Pensacola, Florida, 32514, United States

Location

Parkinson's Treatment Center of SW Florida

Port Charlotte, Florida, 33980, United States

Location

USF HealthParkinson's Disease and Movement Disorders Center

Tampa, Florida, 33613, United States

Location

Guilford Neurologic Associates

West Palm Beach, Florida, 33407, United States

Location

Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, 33407, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

NeuroTrials Research Inc.

Atlanta, Georgia, 30342, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Kansas City Bone & Joint Clinic

Kansas City, Kansas, 66211, United States

Location

International Clinical Research Institute

Overland Park, Kansas, 66210, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Rehabilitation Consultants, PA

Eagan, Minnesota, 55121, United States

Location

University of Medicine and Dentistry of New Jersey

Stratford, New Jersey, 08084, United States

Location

Atlantic Neuroscience Institute

Summit, New Jersey, 07901, United States

Location

Kingston Neurological Associates

Kingston, New York, 12401, United States

Location

The Ichan School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Island Neurological Associates

Plainview, New York, 11803, United States

Location

Guilford Neurologic Associates; Cone Health Medical Group

Greensboro, North Carolina, 27405, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati Physicians Company, LLC

Cincinnati, Ohio, 45267, United States

Location

OHSU Center for Health and Healing

Portland, Oregon, 97239, United States

Location

Penn State Hershey Neurology

Hershey, Pennsylvania, 17033, United States

Location

Coastal Neurology, PA

Port Royal, South Carolina, 29935, United States

Location

North Texas Movement Disorders Institute

Bedford, Texas, 76201, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Puget Sound Neurology

Tacoma, Washington, 98409, United States

Location

Related Publications (1)

• Dashtipour K, Wietek S, Rubin B, Maisonobe P, Bahroo L, Trosch R. AbobotulinumtoxinA using 2-mL dilution (500 U/2-mL) maintains durable improvement across multiple treatment cycles. J Clin Mov Disord. 2020 Aug 31;7:8. doi: 10.1186/s40734-020-00090-x. eCollection 2020.

  PMID: 32884828 DERIVED

Related Links

• A-TL-52120-169

MeSH Terms

Conditions

Torticollis

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Medical Director
• Organization: Ipsen Biopharmaceuticals, Inc.

clinical.trials@ipsen.com

Study Officials

• Medical Director Neurology, M.D.

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 20, 2012
• Study Start: March 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: August 7, 2019
• Results First Posted: May 4, 2017

Record last verified: 2019-07

Locations

US (41)