Efficacy and Safety of Tocotrienols in CADASIL (NCT04658823) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Tocotrienols in CADASIL
France50 participantsStarted 2020-12-21
Plain-language summary
CADASIL is a paradigmatic cerebral small vessel disease responsible for white-matter lesions, accumulation of lacunes, microbleeds and cerebral atrophy. The disease is responsible for stroke and cognitive decline associated with motor disability. The number of incident lacunes, and amount of cerebral atrophy were recently found to have a strong relationship to cognitive decline and disability progression over 3 years in a large sample of patients. Palm tocotrienols has previously shown evidence of therapeutic effect in attenuating the progression of WMH related to sporadic cerebral small vessel disease in a randomized controlled clinical trial. We hypothesize that palm tocotrienols complex (HOV-12020) can reduce the clinical progression in CADASIL.
Who can participate
Age range45 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female
✓. Participants aged 45 to 75 years inclusive, at the time of signing of informed consent
✓. Confirmed Diagnosis of CADASIL, defined by either:
✓. Presence of at least one prevalent lacune on the MRI identified on 3DT1 or FLAIR images.
✓. Presence of Confluent white matter hyperintensities (WMH) on T2-weighted or FLAIR MR images (Fazekas grade 2-3).
✓. MMSE score ≥15
✓. mRS at 0 - 3
✓. A woman of child bearing potential (WOCBP) is eligible to participate if she is not pregnant, not breastfeeding, and agrees to follow contraceptive guidance (as described in Appendix 5) provided by the study clinician during the treatment period and for 28 days after the last dose of the study treatment.
Exclusion criteria
✕. Clinical stroke with persisting neurological deficit within 6 months prior to Screening.
What they're measuring
1
Incidence of manifestations related to clinical worsening
✕. Any other neurodegenerative disorder, such as Parkinson's disease, Alzheimer's disease, or Huntington's disease.
✕. Current significant hematological, cardiac, pulmonary, metabolic, neurologic or psychiatric disorders, uncontrolled seizures, untreated hypertension, disorders increasing risk of bleeding (Hemophilia), or any other significant active medical condition which in the Investigator's opinion would impact participation in this study.
✕. History of myocardial infarction within 3 months prior to Screening, or current active angina pectoris, or symptomatic heart failure.
✕. History of cancer, within the past 5 years. Patients with basal cell carcinoma, squamous cell carcinoma, and Stage 1 prostate cancer can be included in the study.
✕. An episode of major depression within the last 6 months prior to Screening (clinically stable minor depression is not exclusionary).
✕. History of attempted suicide within 6 months prior to Screening or a positive response to items 4 or 5 of Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening and Baseline.
✕. History of drug or alcohol abuse or dependence.