EUCTR2006-006449-14-IT进行中（未招募）不适用
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
ALLERGA0 个研究点目标入组 160 人开始时间: 2007年12月20日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
相似试验
已完成
不适用
A study to compare two different patches for pain relief after surgery of lower limb bone fractureCTRI/2019/02/017417Department of anaesthesiology Pt B D Sharma PGIMS Rohtak75
尚未招募
4 期
To study the comparison of efficacy and safety between injection iron sucrose complex and injection ferric carboxymaltose in the treatment of moderate anemia in pregnancy.CTRI/2024/03/064066GMERS Medical college and hospital Gotri,Vadodara
已完成
3 期
A comparative study between Zitux (Rituximab manufactured by AryoGen) and Mabthera on patients with chronic lymphocytic leukemia (CLL)chronic lymphocytic lukemia.Chronic lymphocytic leukaemia of B-cell typeIRCT201305296302N5AryoGen Biopharma company78
已完成
2 期
Treatment of Psoriasis with IPD admissioCTRI/2018/05/014152Central Council for Research in Unani Medicine120
已完成
2 期
Clinical trial on PsoriasisCTRI/2018/05/013636Central Council for Research in Unani Medicine120