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Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.

2019년 7월 25일 업데이트: Ipsen

A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.

The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

134

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale, Arizona, 미국, 85258
        • Movement Disorders Center of Arizona, LLC
      • Tucson, Arizona, 미국, 85724
        • University of Arizona
    • California
      • Berkeley, California, 미국, 94705
        • East Bay Physician's Group
      • Fountain Valley, California, 미국, 92708
        • Parkinson's and Movement Disorder Institute
      • Loma Linda, California, 미국, 92354
        • Loma Linda University Healthcare, Department of Neurology
      • Los Angeles, California, 미국, 90033
        • USC Keck School of Medicine
      • Sacramento, California, 미국, 95817
        • UC Davis Medical Center
    • Colorado
      • Aurora, Colorado, 미국, 80045
        • University of Colorado at Denver Health Sciences
      • Fort Collins, Colorado, 미국, 80528
        • Advanced Neurosciences Research
    • Connecticut
      • Fairfield, Connecticut, 미국, 06824
        • Associated Neurologists of Southern Connecticut
    • District of Columbia
      • Washington, District of Columbia, 미국, 20007
        • Georgetown University Hospital
    • Florida
      • Boca Raton, Florida, 미국, 33486
        • Parkinson's & Movement Disorders Center of Boca Raton
      • Gainesville, Florida, 미국, 32607
        • University of Florida Center for Movement Disorders and Neurorestoration
      • Pensacola, Florida, 미국, 32514
        • Emerald Coast Center For Neurological Disorders
      • Port Charlotte, Florida, 미국, 33980
        • PD Treatment Center of SW FL
      • Tampa, Florida, 미국, 33606
        • University of South Florida
      • West Palm Beach, Florida, 미국, 33407
        • Premiere Research Institute at Palm Beach Neurology
      • West Palm Beach, Florida, 미국, 33407
        • Guilford Neurologic Associates
    • Georgia
      • Atlanta, Georgia, 미국, 30329
        • Emory University
      • Atlanta, Georgia, 미국, 30342
        • NeuroTrials Research Inc.
    • Illinois
      • Chicago, Illinois, 미국, 60612
        • Rush University Medical Center
    • Kansas
      • Kansas City, Kansas, 미국, 66211
        • Kansas City Bone & Joint Clinic
      • Overland Park, Kansas, 미국, 66210
        • International Clinical Research Institute
    • Massachusetts
      • Boston, Massachusetts, 미국, 02111
        • Tufts Medical Center
    • Minnesota
      • Eagan, Minnesota, 미국, 55122
        • Rehabilitation Consultants PA
    • New Jersey
      • Stratford, New Jersey, 미국, 08084
        • University of Medicine and Dentistry of New Jersey
      • Summit, New Jersey, 미국, 07901
        • Atlantic Neuroscience Institute
    • New York
      • Kingston, New York, 미국, 12401
        • Kingston Neurological Associates
      • New York, New York, 미국, 10029
        • The Ichan School of Medicine at Mount Sinai
      • New York, New York, 미국, 10016
        • Fazzini Parkinson's Disease & Dystonia Center
      • Plainview, New York, 미국, 11803
        • Island Neurological Associates
    • North Carolina
      • Greensboro, North Carolina, 미국, 27405
        • Guilford Neurologic Associates; Cone Health Medical Group
      • Winston-Salem, North Carolina, 미국, 27157
        • Wake Forest School of Medicine
    • Ohio
      • Cincinnati, Ohio, 미국, 45267
        • University of Cincinnati Physicians Company, LLC
    • Oregon
      • Portland, Oregon, 미국, 97239
        • OHSU Center for Health and Healing
    • Pennsylvania
      • Hershey, Pennsylvania, 미국, 17033
        • Penn State Hershey Neurology
    • South Carolina
      • Port Royal, South Carolina, 미국, 29935
        • Coastal Neurology
    • Texas
      • Bedford, Texas, 미국, 76201
        • North Texas Movement Disorders Institute
      • Houston, Texas, 미국, 77030
        • Baylor College of Medicine
      • Houston, Texas, 미국, 77030
        • University of Texas Health Science Center at Houston
    • Washington
      • Tacoma, Washington, 미국, 98409
        • Puget Sound Neurology

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Primary diagnosis of Cervical Dystonia at least 9 months since onset and either previously untreated with botulinum toxin or currently treated with Botox at a total dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last injection cycle, and having had a satisfactory treatment response in the principal investigator's judgment during the last two sequential Botox treatment cycles.
  • TWSTRS total score≥ 20; TWSTRS-severity subscale score> 10;

Exclusion Criteria:

  • In apparent remission from Cervical Dystonia
  • Diagnosis of pure retrocollis or pure anterocollis
  • For non-naïve subjects, previous poor response to either of the last two Botox treatments
  • Known requirement of <100U or >200U of Botox injected into the neck muscles

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Dysport®
Dysport® (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
생물학적: Botulinum toxin type A
Intramuscular injection, between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
다른 이름들:
  • AbobotulinumtoxinA (Dysport®)
위약 비교기: Placebo
Placebo, up to 2mL
의약품: Placebo
Up to 2mL

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.
기간: 4 weeks post-treatment
The change from baseline in the TWSTRS total score at Week 4 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. 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 and at all post-treatment visits.
4 weeks post-treatment

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in TWSTRS Total Score at Week 2.
기간: 2 weeks post-treatment
The change from baseline in the TWSTRS total score at Week 2 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. 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 and at all post-treatment visits.
2 weeks post-treatment
Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2.
기간: 2 weeks post-treatment
The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.
2 weeks post-treatment
TWSTRS Responders at Week 2.
기간: 2 weeks post-treatment
Treatment response was determined as the number of responders at Week 2 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 2 score - baseline score]/baseline score) * 100.
2 weeks post-treatment
Change From Baseline in CGIC in CD at Week 4.
기간: 4 weeks post-treatment
The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.
4 weeks post-treatment
TWSTRS Responders at Week 4.
기간: 4 weeks post-treatment
Treatment response was determined as the number of responders at Week 4 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 4 score - baseline score]/baseline score) * 100.
4 weeks post-treatment
Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4.
기간: 4 weeks post-treatment
The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening.
4 weeks post-treatment
Change From Baseline in CDIP-58 Total Score at Week 2.
기간: 2 weeks post-treatment
The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening. The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 4) reached a statistically significant treatment effect. This secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 2) was performed to characterise the full clinical effect.
2 weeks post-treatment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ipsen

수사관

  • 연구 책임자: Medical Director, Neurology, M.D., Ipsen

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2013년 1월 1일

기본 완료 (실제)

2014년 10월 1일

연구 완료 (실제)

2015년 1월 1일

연구 등록 날짜

최초 제출

2012년 12월 17일

QC 기준을 충족하는 최초 제출

2012년 12월 17일

처음 게시됨 (추정)

2012년 12월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 8월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 7월 25일

마지막으로 확인됨

2019년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • A-TL-52120-169

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