跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2004-002322-22-LT
EUCTR2004-002322-22-LT进行中（未招募）不适用

A multi-center, open-label trial to investigate the safety and tolerability of intravenous SPM 927 as replacement for oral SPM 927 in subjects with partial seizures with or without secondary generalization.

SCHWARZ BIOSCIENCES Inc.0 个研究点目标入组 100 人开始时间: 2004年11月30日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
100
研究概览入排标准研究者记录与标识符相似试验

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. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
  • •2. Subject has, in the opinion of the investigator, adequate seizure control for participation in the trial, and is willing and able to comply with all trial requirements including hospitalization, multiple blood draws and intravenous infusions.
  • •3. Subject is currently enrolled in an open-label extension trial receiving oral SPM 927 for the treatment of partial seizures and has been enrolled for at least 8 weeks.
  • •4. Subject has been on a stable bid dosage regimen between 200mg/day and 600mg/day SPM 927, inclusive, for the last 2 weeks.
  • •5. Subject has been on a stable bid dosage regimen of 700 or 800mg/day SPM 927 for the last 2 weeks. Applicable only if doses above 600mg/day are allowed (see Section 11.1.5.2).
  • •6. Subject has been on a stable dose of concomitant AED(s) for the last 2 weeks.
  • •7. Subject has had stable VNS settings for the last 2 weeks, if applicable
  • •Are the trial subjects under 18? yes
  • •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. Subject is receiving any investigational drugs or using any experimental devices other than SPM 927.
  • •2. Subject has previously received iv SPM 927.
  • •3. Subject meets the withdrawal criteria for the open-label extension trial.
  • •4. Subject has any medical or psychiatric condition that, in the opinion of the investigator, would compromise the subject’s ability to participate in this trial or possibly confound interpretation of the data.
  • •5. Subject has diastolic blood pressure less than 50mm Hg or greater than 105mm Hg or heart rate less than 50 beats per minute (bpm) or greater than 110bpm, measured in a supine position after 3 minutes at rest.
  • •6. Subject has a history of any kind of status epilepticus within the 12-month period prior to trial entry.
  • •7. Subject has confirmed clinically relevant abnormality by ECG.

研究者

相似试验

进行中（未招募）
不适用
A multi-center, open-label trial to investigate the safety and tolerability of intravenous SPM 927 as replacement for oral SPM 927 in subjects with partial seizures with or without secondary generalization.partial seizures with or without secondary generalizationMedDRA version: 6.0Level: LLTClassification code 10034089
EUCTR2004-002322-22-DESCHWARZ BIOSCIENCES Inc.160
进行中（未招募）
1 期
A multi-center, open-label trial to investigate the safety and tolerability of intravenous SPM 927 as replacement for oral SPM 927 in subjects with partial seizures with or without secondary generalizatio
EUCTR2004-002322-22-CZSCHWARZ BIOSCIENCES, Inc.160
进行中（未招募）
不适用
A multi-center, open-label trial to investigate the safety and tolerability of intravenous SPM 927 as replacement for oral SPM 927 in subjects with partial seizures with or without secondary generalization.
EUCTR2004-002322-22-SESCHWARZ BIOSCIENCES Inc.160
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