EUCTR2021-003875-32-IT进行中（未招募）1 期
A double-blind, placebo-controlled, exploratory randomised clinical trial to assess the safety and efficacy of IFB-088 plus riluzole 100 mg vs placebo plus riluzole 100 mg in patients with bulbar-onset amyotrophic lateral sclerosis (Study TRIALS) - TRIALS
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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. Diagnosis of probable or definite ALS according to the revised El Escorial
- •criteria, with bulbar onset of disease, familial or sporadic form,
- •2. Onset of symptoms = 18 months prior to screening, as reported by the patient,
- •3. Adult males or females, aged at least 18 years old,
- •4. SVC > 60% of predicted value for age and sex,
- •5. ALSFRS-R score = 36, with score 3 or 4 for item 3 (swallowing),
- •6. Treatment with riluzole 100 mg/day, at stable dose since at least one month
- •and well tolerated,
- •7. Male or female patient of childbearing potential who agrees to use highly
- •effective mechanical contraception methods (condom, sexual abstinence,
- •intrauterine device, bilateral tubal occlusion, vasectomised partner)
- •throughout the study, and for 3 months after the end of the treatment,
- •8. Patient who read, understood and signed the informed consent form (ICF),
- •9. Patient who is willing to adhere to the study visit schedule and is capable to
- •understand and comply with protocol requirements.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Known other significant neurological disease(s),
- •2. Serious illness(es) or medical condition(s) (e.g. unstable cardiac disease,
- •cancer, hematologic disease, hepatitis or liver failure, renal failure) that is not
- •stabilised or that could require hospitalisation and may jeopardise the
- •participation in the study,
- •3. Other causes of neuromuscular weakness,
- •4. Non progressive or very rapidly progressing ALS (ALSFRS-R decline from
- •disease onset to randomisation = 0.1 / month or = 1.2 / month)1,
- •5. Percutaneous endoscopic gastrostomy or parenteral nutrition,
- •6. Non-invasive ventilation,
- •7. Tracheotomy,
- •8. Weight loss = 10% compared to weight at symptoms onset as declared by the
- •patient or BMI <18 kg/m2 at screening,
- •9. Dementia or other severe active psychiatric illness,
- •10. Patient with a significant pulmonary disorder not attributed to ALS or who
- •require treatments that might complicate the evaluation of the effect of ALS
- •on respiratory function,
- •11. Patient using unauthorised concomitant treatments, namely moderate or
- •strong inhibitors or inducers of cytochrome P450 family 1 subfamily A
- •member 2 (CYP1A2). Combined oral contraceptives containing
- •ethinylestradiol are forbidden concomitant medications,
- •12. Smoker of > 10 cigarettes per day (e-cigarettes and nicotine patches are
- •permitted),
- •13. Known hypersensitivity to any of the ingredients or excipients of the
- •investigational medicinal products (IMPs),
- •14. Pregnant, lactating women,
- •15. Patient who participated in another trial of investigational drug(s) within 30
- •days prior to randomisation,
- •16. Patient who has forfeited their freedom by administrative or legal award, or
- •who is under guardianship or under limited judicial protection.
研究者
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