A study to compare the efficacy and safety of two different types of Botulinum Toxin Type A (BOTOX or Dysport) in the Treatment of Moderate to Severe Cervical Dystonia - ND

• Conditions: treatment of idiopathic cervical dystonia; MedDRA version: 9.1Level: LLTClassification code 10048315Term: Cervical spasm

• Registration Number: EUCTR2006-006449-14-IT
• Lead Sponsor: ALLERGA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-20
• Last Update Posted: 16 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1.Subjects with idiopathic cervical dystonia of the predominantly rotational form (i.e., spasmodic torticollis) of minimum duration eighteen (18) months.
2.Moderate-to-severe symptoms as defined by a minimum Toronto Western Spasmodic Torticollis Scale (TWSTRS) severity scale score of 15, with a rotation score of major or equal to 2 and a duration factor of major or equal to 2.
3.Subjects have received successful treatment as determined clinically by both the investigator and patient with 180 ? 220 U BOTOX in each of the last two (2) treatment sessions.
4.Cervical dystonia symptom severity is considered predictable and successfully responsive to BOTOX treatment.
5.The most recent treatment with BOTOX occurred on a date at least 16 weeks prior to study entry, and the subject has received two (2) treatment sessions within the prior 40 weeks with a good clinical response.
6.Outpatient, male or female subjects, of any race, between 18 and 75 years of age.
7.Normal screening laboratory values and negative urine pregnancy test (if applicable).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Symptomatic or non-idiopathic cervical dystonia.
2.Current or previous surgery, peripheral denervation, and/or spinal cord stimulation for the management of cervical dystonia.
3.Previous injections of phenol or alcohol for cervical dystonia.
4.History or evidence of secondary non-response to botulinum toxin type A therapy.
5.Presence of significant anterocollis, retrocollis, or head shift as the principal component of cervical dystonia.
6.Profound atrophy of the muscles or infection or skin problem in the target area(s) of injection.
7.Any other disease that might interfere with neuromuscular function or any uncontrolled systemic disease
8.Current anticoagulant therapy.
9.Failure to meet prohibited/restricted concomitant medication criteria.
10.Subjects planning inpatient surgery or other elective hospitalization during the study period.
11.Females who are pregnant, nursing, or planning a pregnancy (positive urine pregnancy test) or females of childbearing potential, not using a reliable means of contraception.
12.History of treatment with botulinum toxin type A or B of any brand other than BOTOX within the past two (2) years.
13.Allergy or sensitivity to any component of the study medication.
14.Recent history of alcohol or drug abuse (as defined by DSM IV criteria).
15.History of poor cooperation, non-compliance with medical treatment, or unreliability.
16.Subjects currently participating in another investigational drug study or who have participated in an investigational drug study within 30 days of the Baseline Visit unless approved by the sponsor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified