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Cervical DystoniaPhase 2NCT00165776

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

A Phase 2 study testing BOTULINUM TOXIN TYPE B in people with Cervical Dystonia and Spasmodic Torticollis, run by Eisai Co., Ltd. at 21 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Cervical Dystonia, Spasmodic Torticollis
What is being tested?
BOTULINUM TOXIN TYPE B
How many people
133 participants
Where
21 sitesJapan
Study dates
Jun 2004to Nov 2006
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 74 years
  • All sexes
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Japan21 sites

  • Study site

    Bunkyo-ku, Tokyo, 113-0033

  • Study site

    Hamamatsu, Shizuoka, 430-0906

  • Study site

    Ichihara, Chiba, 290-0003

  • Study site

    Kagoshima, Kagoshima-ken, 890-0075

  • Study site

    Kashihara, Nara, 634-0813

  • Study site

    Kawasaki, Kanagawa, 216-0015

  • Study site

    Kitakyushu, Fukuoka, 807-0804

  • Study site

    Kyoto, Kyoto, 601-1434

  • Study site

    Matsumoto, Nagano, 390-0802

  • Study site

    Meguro-ku, Tokyo, 153-0044

  • Study site

    Moriguchi, Osaka, 570-0074

  • Study site

    Osaka, Osaka, 553-0003

  • Study site

    Sagamihara, Kanagawa, 228-0829

  • Study site

    Saitama, Saitama, 338-0002

  • Study site

    Saitama, Saitama, 338-0003

  • Study site

    Sakai, Osaka, 590-0132

  • Study site

    Sapporo, Hokkaido, 060-0061

  • Study site

    Sapporo, Hokkaido, 060-0814

  • Study site

    Shinjuku-ku, Tokyo, 162-0054

  • Study site

    Tokorozawa, Saitama, 359-1141

  • Study site

    Tokushima, Tokushima, 770-0042

Other trials in Japan

About this study

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.

Being tested
BOTULINUM TOXIN TYPE B
Medical subject headings
Torticollis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BOTULINUM TOXIN TYPE BDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 4

Secondary outcomes (6)

  1. 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.

    Measured: Baseline, Week 4

  2. 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.

    Measured: Baseline, Week 4

  3. 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.

    Measured: Baseline, Week 4

  4. 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.

    Measured: Baseline, Week 4

  5. 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.

    Measured: Baseline, Week 4

  6. 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.

    Measured: Baseline, Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startJun 2004
  3. Primary completionMay 2006
  4. Study completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00165776
Sponsor's protocol ID
E2014-J081-131
Status last verified
Feb 2014
First submitted
12 Sep 2005
Last updated
10 Mar 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BOTULINUM TOXIN TYPE B in people with Cervical Dystonia and Spasmodic Torticollis, run by Eisai Co., Ltd. at 21 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Treatment (time frame: Baseline, Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00165776.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2014.

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