FELL-HD
Research type
Research Study
Full title
FELL-HD: A trial to assess the tolerability of using felodipine to upregulate autophagy as a treatment of Huntington’s disease
IRAS ID
1004614
Contact name
Roger Barker
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Eudract number
2021-000897-27
ISRCTN Number
ISRCTN56240656
Research summary
Huntington's disease (HD) is an inherited condition that causes damage to cells in the brain over time due to the production of an abnormal protein called mutant huntingtin (mHTT). Currently there is no cure for HD and its progress cannot be reversed or slowed down.
One way to try and stop HD progressing is to increase (upregulate) its clearance from cells. One normal process that cells use to clear proteins (including mHTT) is called autophagy.Felodipine is a drug which has been shown in animal models to upregulate the autophagy process. The purpose of this trial is to test the safety and tolerability of different doses of felodipine in early-stage HD.
Participants will be assigned to one of three dosing cohorts (6 participants per cohort) in an alternating fashion, where participant 1 will be allocated to cohort 1, participant 2 will be allocated to cohort 2, participant 3 will be allocated to cohort 3, participant 4 will be allocated to cohort 1, and so on:
- Cohort 1: start on 2.5mg, increase to 5mg at week 2 and stay on 5mg until week 58
- Cohort 2: start on 2.5mg, increase to 5mg at week 2, increase to 10mg at week 4, and stay on 10mg until week 58
- Cohort 3: start on 2.5mg, increase to 5mg at week 2, increase to 10mg at week 4, increase to 20mg at week 6, and stay on 20mg until week 58
The dose will only be increased if it has been tolerated at the previous lower dose. If a dose is not tolerated, the participant will be reduced back to the previous dose that was tolerated.18 participants will be recruited, aged 35-70 years (inclusive) with genetically and clinically confirmed early-stage HD. The trial duration will be up to 66 weeks, including a 4-week screening window, 58-week treatment period, and a 4-week wash out period, concluding with an end of trial visit at week 62.
REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0387
Date of REC Opinion
20 Jun 2022
REC opinion
Further Information Favourable Opinion