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

Primary Purpose

Cervical Dystonia, Spasmodic Torticollis

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
BOTULINUM TOXIN TYPE B
Sponsored by
Eisai Co., Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Dystonia

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All Sexes

Inclusion Criteria: Patients who can give written informed consent and aged between greater than or equal to 20 years and less than 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 greater than or equal to 40 kg. Patients whose TWSTRS total score at baseline is greater than or equal to 20. Patients whose TWSTRS-severity score at baseline is greater than or equal to 10. Patients whose TWSTRS-disability score at baseline is greater than or equal to 3. Patients whose TWSTRS-pain score at baseline is greater than or equal to 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

Sites / Locations

Outcomes

Primary Outcome Measures

Mean Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Treatment
The TWSTRS-Total score is the sum of scores of the three components of the scale: TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

Secondary Outcome Measures

Mean Change From Baseline in Patient Global Assessment - Visual Analog Scale (PtGA-VAS) at Week 4 After Treatment
Change from Baseline in PtGA-VAS is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. Participants answered: "Considering all the ways your cervical dystonia affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Mean Change From Baseline in Physician Global Assessment Disease Assessment - Visual Analog Scale (PGA-VAS) at Week 4 After Treatment
Change from Baseline in PGA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement.
Mean Change From Baseline in the TWSTRS - Functional Disability Score at Week 4 After Treatment
TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Mean Change From Baseline in the TWSTRS - Pain Score at Week 4 After Treatment
TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Mean Change From Baseline in the TWSTRS - Severity Score at Week 4 After Treatment
TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Mean Change From Baseline in Patient Pain Assessment (VAS) at Week 4 After Treatment
Change from Baseline in Patient's Pain Assessment-VAS is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. The patient's assessment of pain was performed using a 100 mm VAS)ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.

Full Information

First Posted
September 12, 2005
Last Updated
February 6, 2014
Sponsor
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00165776
Brief Title
Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Dose-Response, Study of E2014 in Patients WIth Spasmodic Torticollis
Official Title
Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Dose-Response, Study of E2014 in Patients WIth Spasmodic Torticollis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia, Spasmodic Torticollis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BOTULINUM TOXIN TYPE B
Primary Outcome Measure Information:
Title
Mean Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Treatment
Description
The TWSTRS-Total score is the sum of scores of the three components of the scale: TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time Frame
Baseline, Week 4
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Patient Global Assessment - Visual Analog Scale (PtGA-VAS) at Week 4 After Treatment
Description
Change from Baseline in PtGA-VAS is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. Participants answered: "Considering all the ways your cervical dystonia affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Time Frame
Baseline, Week 4
Title
Mean Change From Baseline in Physician Global Assessment Disease Assessment - Visual Analog Scale (PGA-VAS) at Week 4 After Treatment
Description
Change from Baseline in PGA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement.
Time Frame
Baseline, Week 4
Title
Mean Change From Baseline in the TWSTRS - Functional Disability Score at Week 4 After Treatment
Description
TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time Frame
Baseline, Week 4
Title
Mean Change From Baseline in the TWSTRS - Pain Score at Week 4 After Treatment
Description
TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time Frame
Baseline, Week 4
Title
Mean Change From Baseline in the TWSTRS - Severity Score at Week 4 After Treatment
Description
TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Time Frame
Baseline, Week 4
Title
Mean Change From Baseline in Patient Pain Assessment (VAS) at Week 4 After Treatment
Description
Change from Baseline in Patient's Pain Assessment-VAS is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. The patient's assessment of pain was performed using a 100 mm VAS)ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.
Time Frame
Baseline, Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Eligibility Criteria
Inclusion Criteria: Patients who can give written informed consent and aged between greater than or equal to 20 years and less than 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 greater than or equal to 40 kg. Patients whose TWSTRS total score at baseline is greater than or equal to 20. Patients whose TWSTRS-severity score at baseline is greater than or equal to 10. Patients whose TWSTRS-disability score at baseline is greater than or equal to 3. Patients whose TWSTRS-pain score at baseline is greater than or equal to 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
Facility Information:
City
Ichihara
State/Province
Chiba -prefecture
ZIP/Postal Code
290-0003
Country
Japan
City
Kitakyushu
State/Province
Fukuoka -prefecture
ZIP/Postal Code
807-0804
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0061
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0814
Country
Japan
City
Kagoshima
State/Province
Kagoshima-prefecture
ZIP/Postal Code
890-0075
Country
Japan
City
Sagamihara
State/Province
Kanagawa -prefecture
ZIP/Postal Code
228-0829
Country
Japan
City
Kawasaki
State/Province
Kanagawa-prefecture
ZIP/Postal Code
216-0015
Country
Japan
City
Matsumoto
State/Province
Nagano-prefecture
ZIP/Postal Code
390-0802
Country
Japan
City
Kashihara
State/Province
Nara-prefecture
ZIP/Postal Code
634-0813
Country
Japan
City
Moriguchi
State/Province
Osaka
ZIP/Postal Code
570-0074
Country
Japan
City
Sakai
State/Province
Osaka
ZIP/Postal Code
590-0132
Country
Japan
City
Saitama
State/Province
Saitama-prefecture
ZIP/Postal Code
338-0002
Country
Japan
City
Saitama
State/Province
Saitama-prefecture
ZIP/Postal Code
338-0003
Country
Japan
City
Tokorozawa
State/Province
Saitama-prefecture
ZIP/Postal Code
359-1141
Country
Japan
City
Hamamatsu
State/Province
Shizuoka-prefecture
ZIP/Postal Code
430-0906
Country
Japan
City
Tokushima
State/Province
Tokushima-prefecture
ZIP/Postal Code
770-0042
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-0033
Country
Japan
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
153-0044
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-0054
Country
Japan
City
Kyoto
ZIP/Postal Code
601-1434
Country
Japan
City
Osaka
ZIP/Postal Code
553-0003
Country
Japan

12. IPD Sharing Statement

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

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