NL-OMON52129招募中3 期
Clemastine fumarate as remyelinating treatment in internuclear ophthalmoparesis and multiple sclerosis - RESTORE
Amsterdam UMC0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. A clinically definite diagnosis of multiple sclerosis.
- •2. Diagnosis of internuclear ophthalmoplegia determined by the first infrared
- •oculography at screening with either cut-off of 1.174 of the versional
- •dysconjugacy index area under the curve (VDI-AUC) of 15° saccades or 1.180 of
- •the versional dysconjugacy index peak velocity/saccadic amplitude (VDI-PV/Am)
- •of 15° saccades.
- •3. Age 18-70 (inclusive)
- •4. Use of disease modifying therapies is not a contraindication.
- •5. Ability to understand the purpose and risks of the study and provide signed
- •and dated informed consent.
排除标准
- •MS-related exclusion criteria:
- •1. Changes in immunomodulatory therapy for multiple sclerosis in the 6 months
- •before inclusion into the study.
- •2. Clinical relapse of MS or high dosage corticosteroid use within 30 days
- •before inclusion into the study.
- •IMP and medication related exclusion criteria:
- •3. Contraindications to clemastine use, such as known porphyria or
- •hypersensitivity to clemastine, other antihistamines with a similar chemical
- •structure or any of the excipients.
- •4. Contraindications to fampridine use, such as hypersensitivity to fampridine
- •or any of the excipients, history of epilepsy, kidney disease (GFR <50 ml/min
- •absolute contraindication; GFR = 50-80 ml/min relative contraindication), use
- •of Organic Cation Transporter 2 (OCT2) inhibitors or history of significant
- •cardiac arrhythmias or conduction block.
- •5. Concomitant use of Fampridine or any other formulation of 4-aminopyridine
- •(4AP) or diamino4ap that cannot be temporarily suspended prior to each study
- •6. Changes in the use of medication currently being investigated in
- •remyelination trials within 6 months before screening, including but not
- •limited to domperidone, liothyronine, quetiapine, testosterone and bazedoxifene.
- •7. Non-incidental use of central nervous system depressants including but not
- •limited to hypnotics, anxiolytics, monoamine-oxidase inhibitors (MAOI*S),
- •tricyclic antidepressants, opioid analgesics and other antihistamines with
- •sedating properties (e.g. promethazine).
- •Other medical history and concomitant disease exclusion criteria:
- •8. History of significant cardiac conduction block.
- •9. History of malignancy of any organ system (other than localized squamous or
- •basal cell carcinoma of the skin or adequately treated cervical cancer),
- •treated or untreated, within the past 3 years, regardless of whether there is
- •evidence of local recurrence or metastases.
- •10. Estimated glomerular filtration rate (eGFR) < 50 ml/min/1.73 m2; AST, ALT,
- •or alkaline phosphatase > 3 times the upper limit of normal.
- •11. Any ophthalmological disease which may prevent accurate infrared
- •oculography assessment.
- •12. Suicidal ideation or behaviour in 6 months prior to baseline.
- •13. History of drug or alcohol abuse within the past year.
- •14. Clinically significant cardiac, metabolic, hematologic, hepatic,
- •immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric,
- •dermatologic, allergic, renal or other major diseases that in the PI*s
- •judgement may affect interpretation of study results or patient safety.
- •15. History of or presence of clinically significant medical illness or
- •laboratory abnormality that, in the opinion of the investigator would preclude
- •participation in the study.
- •General exclusion criteria:
- •16. Pregnancy at the time of inclusion into the study or planning on
- •breastfeeding within the first 7 months after inclusion in the study.
- •17. Involvement in other study protocol simultaneously without prior approval.
- •18. Insufficient proficiency in reading Dutch or English.
- •19. Unable or unwilling to suspend driving for a duration of 6 months.
研究者
相似试验
进行中（未招募）
1 期
Clemastine fumarate as remyelinating treatment in internuclear ophthalmoparesis and multiple sclerosisCTIS2024-513099-17-00Amsterdam UMC Stichting80
招募中
3 期
Clemastine fumarate as remyelinating treatment in internuclear ophthalmoparesis and multiple sclerosisMultiple sclerosis2024-513099-17-00Amsterdam UMC Stichting80
终止
3 期
Clemastine Fumarate as Remyelinating Treatment in Internuclear Ophthalmoparesis and Multiple SclerosisMultiple SclerosisInternuclear OphthalmoplegiaNCT05338450Amsterdam UMC, location VUmc47
已完成
3 期
Evaluation of Therapeutic and safety of clemastine fumarate in symptoms and quality of life in secondry Relapsing MS patientsMultiple sclerosisMultiple sclerosis.IRCT20080901001165N40Bagheiat-allah University of Medical Sciences120
已完成
2 期
Assessment of Clemastine Fumarate as a Remyelinating Agent in Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingNCT02040298University of California, San Francisco50