EUCTR2007-003817-15-IT进行中（未招募）不适用
Prospective, open-label, multi-center trial to investigate efficacy and safety of Xeomin in the treatment of post-stroke spasticity in the lower limb - ND
AZIENDA SANITARIA LOCALE N 15 DI CUNEO0 个研究点开始时间: 2007年11月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •- Post-stroke (ischaemic or hemorrhagic) patients - Lower-limb spasticity with equinovarus (including dynamic equinovarus)- Female or male patients, ≥ 18 - 75 years - For pre-treated patients only: source documentation of the most recent injection session with Botulinum Toxin and sufficient therapeutic response for equinovarus - For pre-treated patients only: Stable treatment with oral antispastic drugs of ≥3 weeks. - Autonomous walking (with or without aid) for at least 10 meters - Ashworth Scale ≥1 of the plantar flexors - Ashworth Scale ≥1 of the ankle/foot invertors - Foot plantiflexion during swing phase - Foot inversion during swing phase - maximum active ankle ROM at least limited to 10 in the affected side.
- •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
- •- Limited passive ankle dorsiflexion >0 - Flaccid drop foot - Planned concomitant treatment with Botulinum Toxin of any serotype and for any body region - Previous or planned treatment with phenol- or alcohol-injection in the target limb - Previous surgical treatment of spasticity in the target muscle(s) - Severe atrophy of the target limb muscles - Limited passive ankle pronation Please define - Pregnancy and lactation - Non complete rehabilitation program which is during the last 4 weeks preceding screening - - Mini Mental State Examination <24 - Previous focal treatments for lower limb spasticity. Except treatment with Botulinum Toxin ≥ 5 months before screening visit. - Fixed contracture, defined as severe restriction of the range of joint movement on passive stretch of ankle or knee - Impaired function of lower limb due to any other condition than post-stroke equinovarus. - Severe or uncontrolled systemic disease. - Other muscle hypertonia, e.g., rigidity - INR value > 2.5 on injection day - Result of hematological/clinical chemistry-analysis at baseline which is considered as abnormal and clinically significant (ie indicating the presence of a severe or uncontrolled systemic disease).
研究者
相似试验
进行中（未招募）
1 期
Prospective, open-label, monocenter, trial to investigate the efficacy and tolerability of Vagisan® a lactic acid containing vaginal suppository, in a panel of post-menopausal women suffering from vulvo vaginal atrophy (VVA)vulvovaginal atrophyMedDRA version: 21.1Level: LLTClassification code 10047782Term: Vulvovaginal atrophySystem Organ Class: 100000004872EUCTR2019-002325-30-DEDr. August Wolff GmbH & Co. KG Arzneimittel43
进行中（未招募）
1 期
A multi-center, open-label trial investigating the efficacy and safety of continued treatment with tisotumab vedotin in patients with solid tumors known to express tissue factorCancer of the ovary, cervix, endometrium, bladder, prostate (castrationresistant prostate cancer [CRPC]), esophagus, lung (non-small cell lung cancer [NSCLC]), and Squamous cell carcinoma of the head and neck (SCCHN)MedDRA version: 19.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: HLTClassification code 10014742Term: Endometrial neoplasms malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10008342Term: Cervix carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10023774Term: Large cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10062878Term: Gastrooesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-004743-37-SEGenmab A/S25
进行中（未招募）
1 期
A multi-center, open-label trial investigating the efficacy and safety of continued treatment with tisotumab vedotin in patients with solid tumors known to express tissue factorCancer of the ovary, cervix, endometrium, bladder, prostate (castrationresistant prostate cancer [CRPC]), esophagus, lung (non-small cell lung cancer [NSCLC]), and Squamous cell carcinoma of the head and neck (SCCHN)MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10014742Term: Endometrial neoplasms malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10008342Term: Cervix carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10023774Term: Large cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: PTClassification code 10062878Term: Gastrooesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-004743-37-GBGenmab A/S25
进行中（未招募）
1 期
A multi-center, open-label trial investigating the efficacy and safety of continued treatment with tisotumab vedotin in patients with solid tumors known to express tissue factorEUCTR2016-004743-37-HUGenmab A/S25
进行中（未招募）
1 期
A multi-center, open-label trial investigating the efficacy and safety of continued treatment with tisotumab vedotin in patients with solid tumors known to express tissue factorCancer of the ovary, cervix, endometrium, bladder, prostate (castrationresistant prostate cancer [CRPC]), esophagus, lung (non-small cell lung cancer [NSCLC]), and Squamous cell carcinoma of the head and neck (SCCHN)MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: HLT Classification code 10014742 Term: Endometrial neoplasms malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10008342 Term: Cervix carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10023774 Term: Large cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1 Level: PT Classification code 10062878 Term: Gastrooesophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: SOCEUCTR2016-004743-37-BEGenmab A/S25