Hydroxychloroquine in progressive MS
- Conditions
- Progressive multiple sclerosisMedDRA version: 21.1Level: PTClassification code 10053395Term: Progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2022-003170-23-FI
- Lead Sponsor
- Varsinais-Suomen sairaanhoitopiirin kuntayhtymä
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
1.Written informed consent obtained
2.Men and women who are 35-65 years of age at time of consent
3.With Primary Progressive Multiple Sclerosis, according to current diagnostic criteria (Polman et al., 2005) or non-active Secondary Progressive Multiple Sclerosis (nSPMS, with no relapses in the last 2 years)
4.Screening Expanded Disability Status Scale (Kurtzke, 1983) (EDSS) score between 3.5 and 7.0 at screening.
5.Worsening of MS symptoms or enlarging of T1 lesions in brain MRI during the previous 2 years The worsening of MS symptoms can be indicated as an increase in total EDSS, or as an increase in points in Kurzke’s functional system evaluation over the last two years. Enlargement of T1 lesions is determined by visual inspection by the treating neurologist or clinical neuroradiologist.
6.Patients must, in the investigator’s opinion, exhibit reliability and physiologic capability (e.g., sufficient vision, hearing, etc.) to comply with all protocol procedures, and have attained an educational achievement of minimum 8th grade
7.Patients must be fluent in the Finnish language
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 29
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
1.Patients undergoing treatment with other antimalarial drugs, amiodarone, dapsone or digoxin, other drugs associated with a significant risk for QT prolongation, systemic glucocorticoids, or immunorupressing drugs mitoxantrone, cyclophosphamide, natalizumab, alemtuzumab or cladribine
2.Patients with other neurodegenerative disease or other significant neurological disease than MS (including epilepsy); patients with any generalized seizures within one year of screening are also excluded
3.Patients with known significant spinal cord lesion burden, where clinical worsening is likely due to spinal cord involvement rather than brain involvement. This is assessed by the treating neurologist.
4.Patients with major psychiatric illness in the past 3 years prior to screening
5.Any suicidal behavior in the past 1-year period prior to screening or during the screening period
6.Suicidal ideation type 5 in the C-SSRS (i.e. active suicidal thought with plan and intent) in the past 6 months prior to screening or during the screening period; patients with suicidal ideation type 4 in the C-SSRS
7.Positive urine test result for drugs of abuse at the screening or baseline visit, unless explained in a manner acceptable by the investigator by the patient’s medical history and concomitant medications
8.Patients whose screening ophthalmological examination shows retinopathy
9.Patients whose screening MRI scan shows gadolinium enhancing lesions
10.Patients with significant abnormal findings other than MS-related in the screening MRI
11.Patients with moderate or severe renal insufficiency
12.Patients with indication of liver disease
13.Active infection with hepatitis B or C virus
14.Patients with known active infection with the SARS-CoV-2 virus within the last 35 days prior to the baseline visit
15.Patients with known porphyria or psoriasis
16.Patients with known allergy or other intolerability to HCQ, or to gadolinium MRI contrast agent
17.Patients who are unable or unwilling to undergo gadolinium enhanced MRI scans
18.Patients with claustrophobia, or a history of moderate-to-severe anxiety disorder or panic attacks
19.Pregnant or breast-feeding women, and women of child-bearing potential (WOCBP) with heterosexual relationships who are not capable or willing to use highly effective birth control measures
20.Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study
21.Patients with intolerance to previous PET scans
22.Participation in another investigational drug trial in the 3 months prior to baseline, or within 4 elimination half-lives of the trial medication, whichever is longer
23.Patients who are using systemically acting glucocorticoids during the study period; use of topical formulations (ointments, nasal sprays, eye drops etc.) is allowed
24.Evidence of current or history of any significant autoimmune disease that, in the opinion of the investigator, could interfere with evaluation of the study results or constitute a health hazard for the subject
25.Evidence of an immune system that is compromised; including, but not limited to, a diagnosis of HIV; or the subject has been splenectomised or has received an organ transplant (corneal transplants excluded)
26.Diagnosis of cancer (haematological or solid tumour) for which the subject is currently being treated, or for which there is evidence of active disease. Subjects with local prostate cancer or local dermatological tumou
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method