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Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Dose-Response, Study of E2014 in Patients WIth Spasmodic Torticollis

This study has been completed.

Sponsored by: Eisai Limited
Information provided by: Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00165776
  Purpose

To evaluate efficacy and safety of E2014 (2500U, 5000U, 10000U, placebo) in a multicenter, randomized, double-blind, parallel group comparative study by intramuscularly administering to patients with spasmodic torticollis. Primary endpoint for efficacy evaluation is changes in TWSTRS total scores from baseline measured at Week 4 and the clinical recommended dose will be examined with Williams multiple comparison. For safety evaluation, an inter group comparison (active drug and placebo) will be performed mainly focusing on incidence of adverse events, adverse drug reactions, and abnormal changes in laboratory parameters.


Condition Intervention Phase
Cervical Dystonia, Spasmodic Torticollis
Drug: BOTULINUM TOXIN TYPE B
Phase II

Genetics Home Reference related topics:   early-onset primary dystonia    familial paroxysmal nonkinesigenic dyskinesia   

MedlinePlus related topics:   Dystonia   

Drug Information available for:   Clostridium botulinum toxin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Dose-Response, Study of E2014 in Patients WIth Spasmodic Torticollis

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:
  • Efficacy:
  • Changes in TWSTRS* total scores from baseline at Week 4
  • (*Toronto Western Spasmodic Torticollis Rating Scale)

Secondary Outcome Measures:
  • Changes in TWSTRS-severity score, -disability score, -pain scores from baseline at Week 4
  • Physician's global assessment at Week 4 (VAS)
  • Patient's global assessment (VAS) and pain assessment (VAS) at Week 4

Study Start Date:   June 2004
Study Completion Date:   November 2006
Primary Completion Date:   May 2006 (Final data collection date for primary outcome measure)

  Eligibility
Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both

Criteria

Inclusion Criteria:

  • Patients who can give written informed consent and aged between ≧20 years and <75 years at the time of obtaining prior consent (irrespective of gender).
  • Patients with dystonic symptoms at least 2 or more lesions in the following cervical muscles.
  • Sternocleidomastoid
  • Scalenus complex (scalenus anterior, scalenus medius, and scalenus posterior)
  • Trapezius
  • Levator scapulae
  • Splenius capitis
  • Semispinalis capitis
  • Patients who persistently have symptoms in the above (2) for 1 year or longer.
  • Patients weighing ≧40 kg.
  • Patients whose TWSTRS total score at baseline is ≧20.
  • Patients whose TWSTRS-severity score at baseline is ≧10.
  • Patients whose TWSTRS-disability score at baseline is ≧3.
  • Patients whose TWSTRS-pain score at baseline is ≧1.
  • Patients who are judged to be eligible for study entry by the investigator or subinvestigator based on their physical and neurological findings, laboratory parameters, and ECG results.

Exclusion Criteria:

  • Patients who are botulinum toxin-resistant in previous exposures (primary no-responder*)

    *If patients who were once responder to botulinum toxin treatment but thereafter became non-responder can be included in this study.

  • Patients whose passive range of motion in the neck is significantly narrowed due to cervical contracture or spondylosis.
  • Patients having only pure retrocollis- or anterocollis-associated symptoms.
  • Patients who received botulinum toxin agents within 4 months prior to study treatment of E2014, or those who show carry-over effect of previous treatment with botulinum toxin at the time of starting study administration even though the previous treatment was given 4 months or earlier.
  • Patients who were treated with narcotics or antibiotics that may potentiate effects of muscle relaxation (spectinomycin hydrochloride preparations, aminoglycosides, polypeptides, tetracyclines, lincomycins) within 4 months prior to study treatment.
  • Patients who started or altered the dose levels of the following agents (musculoskeletal relaxants, antispasm drugs, strong tranquilizers, benzodiazepines including similar drugs, anticholinergic drugs, antiparkinsonian drugs, antidepressants) within 4 weeks prior to study treatment.
  • Patients who received medical care(s) other than pharmacotherapies (surgical interventions, MAB, acupuncture, relaxation, etc.) prior to study treatment showing carry-over effect of these cares or unstable condition at the time of starting study treatment.
  • Patients who have a history of myectomy or neurectomy in the neck and/or shoulder.
  • Patients who have a history of hypersensitivity to E2014's ingredients (botulinum toxin type B, human serum albumin, sodium succinate buffer solution), or other type of botulinum toxins.
  • Patients with complication(s) or history of serious neurological or musculoskeletal disease (myasthenia, amyotrophic lateral sclerosis, etc.), cardiovascular disease (acute myocardial infarction, etc.), respiratory disease (COPD, etc.), renal disease (acute or chronic renal failure, etc.), hepatic disease (cirrhosis, etc.), gastrointestinal disease (paralytic ileus, etc.), dermatological disease (toxic epidermal necrosis, etc.), psychiatric disease (schizophrenia, alcohol or drug dependence, etc.), hematological disease (aplastic anemia, etc.), and/or infectious disease (hepatitis, syphilis, AIDS, etc.).
  • Patients with complication or history of malignant tumor(s).
  • Patients who participated in another clinical study within 30 days prior to obtaining informed consent for this study.
  • Women of pregnant, childbearing potential, childbearing intension during the study period, or lactating.
  • Others who are judged to be ineligible for study entry by the investigator or subinvestigator
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165776

Locations
Japan
      Kyoto, Japan, 601-1434
      Osaka, Japan, 553-0003
Japan, Chiba -prefecture
      Ichihara, Chiba -prefecture, Japan, 290-0003
Japan, Fukuoka -prefecture
      Kitakyushu, Fukuoka -prefecture, Japan, 807-0804
Japan, Hokkaido
      Sapporo, Hokkaido, Japan, 060-0061
      Sapporo, Hokkaido, Japan, 060-0814
Japan, Kagoshima-prefecture
      Kagoshima, Kagoshima-prefecture, Japan, 890-0075
Japan, Kanagawa -prefecture
      Sagamihara, Kanagawa -prefecture, Japan, 228-0829
Japan, Kanagawa-prefecture
      Kawasaki, Kanagawa-prefecture, Japan, 216-0015
Japan, Nagano-prefecture
      Matsumoto, Nagano-prefecture, Japan, 390-0802
Japan, Nara-prefecture
      Kashihara, Nara-prefecture, Japan, 634-0813
Japan, Osaka
      Sakai, Osaka, Japan, 590-0132
      Moriguchi, Osaka, Japan, 570-0074
Japan, Saitama-prefecture
      Saitama, Saitama-prefecture, Japan, 338-0002
      Saitama, Saitama-prefecture, Japan, 338-0003
      Tokorozawa, Saitama-prefecture, Japan, 359-1141
Japan, Shizuoka-prefecture
      Hamamatsu, Shizuoka-prefecture, Japan, 430-0906
Japan, Tokushima-prefecture
      Tokushima, Tokushima-prefecture, Japan, 770-0042
Japan, Tokyo
      Meguro-ku, Tokyo, Japan, 153-0044
      Shinjuku-ku, Tokyo, Japan, 162-0054
      Bunkyo-ku, Tokyo, Japan, 113-0033

Sponsors and Collaborators
Eisai Limited

Investigators
Study Director:     Hiroki Shimizu     Development Clinical Research Department. Clinical Research Center    
  More Information


ClinicalStudyResults.org ID number 3492  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   E2014-J081-131
First Received:   September 12, 2005
Last Updated:   October 8, 2008
ClinicalTrials.gov Identifier:   NCT00165776
Health Authority:   Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:
Dystonic Disorders
Signs and Symptoms
Torticollis
Botulinum Toxins
Movement Disorders
Neurologic Manifestations
Central Nervous System Diseases
Dystonia
Dyskinesias

Additional relevant MeSH terms:
Anti-Dyskinesia Agents
Therapeutic Uses
Nervous System Diseases
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2008




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