An Open-Label Extension Study To Assess Long Term Safety And Effectiveness Of Dysport In Adults With Cervical Dystonia (CD)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01753336
First received: December 17, 2012
Last updated: August 21, 2014
Last verified: August 2014
  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


Condition Intervention Phase
Cervical Dystonia
Drug: Dysport
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Treatment response in Treatment Cycle 3. [ Time Frame: Baseline and Week 4 visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change from treatment cycle baseline in TWSTRS disability subscale score [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]
  • Change from treatment cycle baseline in TWSTRS pain subscale score [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 toxin 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 botulinum toxin or related compounds, or any component in the study drug formulation
  • Allergy to cow's milk protein
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753336

  Show 41 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Kathleen G Lomax, M.D. Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01753336     History of Changes
Other Study ID Numbers: A-TL-52120-170
Study First Received: December 17, 2012
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014