CTRI/2019/01/016948招募中4 期
A multi-centric, open label study to evaluate safety and efficacy of Dalfampridine extended release tablets for walking improvement in patients with Multiple Sclerosis in India
试验速览
- 阶段
- 4 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female patient aged between 18 and 65 years (both inclusive)
- •2.Patient has history of confirmed clinically defined multiple sclerosis since 4 months of screening
- •3.The patient has MS-related walking impairment but has sufficient ambulatory ability to be able to complete two trials of the Timed 25 Foot Walk (T25FW) in an average time of 8-45 seconds at the screening visit
- •4.Patient is able to perform all the required study procedure
- •5.Female patient of childbearing potential must be willing to use acceptable method of contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilised, or has not had a hysterectomy at least three months prior to the start of this study. Acceptable method of contraception includes (e.g., barrier method with spermicide). The calendar method, withdrawal, or an IUD is NOT an acceptable method.
排除标准
- •1.Patient is pregnant or lactating
- •2.Patient on concurrent treatment with OCT2 (Organic Cation Transporter 2) inhibitors like cimetidine, pilsicainide, cetirizine, quinidine, rifampicin, naringin, ritonavir
- •3.Patient has any history of seizures or current evidence of epileptiform activity on EEG
- •4.Patient has renal impairment as defined by creatinine clearance of = 80 mL/min
- •5.Patient has active urinary tract infection (UTI) at screening or within the 4 weeks before screening
- •6.Patient had an onset (as assessed by the treating physician) of MS exacerbation within 60 days prior to the screening visit
- •7.Patient has received cyclophosphamide or mitoxantrone for MS treatment within six months prior to the screening visit
- •8.Patient has received corticosteroid (other than topical preparations) within 30 days prior to the screening visit and/or is expected to receive regularly scheduled corticosteroid treatment during the course of the study
- •9.Patient has been administered botulinum toxin in the lower extremities within six months prior to the screening visit and/or is expected to receive botulinum toxin in the lower extremities during the course of the study
- •10.Patient planning to use other forms of 4-aminopyridine (e.g. 4-AP, fampridine) concomitantly during the trial
- •11.Patient allergic to pyridine-containing substances (e.g. esomeprazole, loratidine, crizotinib, montelukast, pioglitazone, eszopiclone, imatinib, lansoprazole, mirtazapine) having hypersensitivity including anaphylaxis or any other contraindication to Investigational product or any of the component of study treatment
- •12.Patient starting immunomodulatory treatment within 90 days prior to screening visit or any change in the dosing regimen of these drugs within 30 days prior to screening visit
- •13.Patient started a concomitant medication regimen within the preceding 3 weeks of screening or their concomitant medication regimen expected to change during the course of trial
- •14.Patient has a history of drug or alcohol abuse within past year as per DSM-5
- •15.Patient with history of HIV and/ or Hepatitis B and/ or Hepatitis C
- •16.Patient has clinically significant abnormal laboratory values or an abnormal ECG in the opinion of investigator
- •17.Patient has any medical condition (including psychiatric disease) in the opinion of investigator that would interfere with the interpretation of the study results or the conduct of the study
- •18.Patient has angina, uncontrolled hypertension (BP = 140/90 mm of Hg), clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality or any other clinically significant disorder
- •19.Patient has participated in an investigational drug/ device trial within 30 days prior to screening visit or plan to enroll in any investigational drug/ device trial at any time during the trial
- •20.Patient operating heavy complex machinery or who intend to drive
- •21.Patient judged unfit for this study by investigator
- •22.Investigator, study personnel, sponsor representatives and their first degree relatives
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