A trial to look at how different doses of felodipine are tolerated in people with early-stage Huntington’s disease

Phase 2

Completed

• Conditions: Huntington disease; Nervous System Diseases

• Registration Number: ISRCTN56240656
• Lead Sponsor: Cambridge Clinical Trials Unit

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39174070/ (added 23/08/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-08
• Study Completion: 2024-04-30
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Have given written informed consent
2. Be male or female, aged 35 to 70 years (inclusive)
3. Be a fluent English speaker, as assessed by the trial team during the screening visit, to enable completion of the cognitive assessments
4. Have early disease, as defined by a Unified Huntington’s disease Rating Scale (UHDRS) total functional capacity (TFC) score =9
5. Have a diagnostic confidence level (DCL) of =2

Exclusion Criteria

1. Participant has dementia (as defined by MMSE <24 and/or ACE-III <82) or lacks capacity to consent for themselves
2. Significant co-morbidities which, in the opinion of the Principal Investigator (PI), precludes inclusion in the trial
3. Ongoing medical or psychiatric condition that is not, in the opinion of the PI, adequately managed
4. Vital sign abnormality which, in the opinion of the PI, precludes inclusion in the trial including symptomatic hypotension
5. Poorly controlled features of HD, as indicated by a change in HD medication within 3 months of screening
6. Contraindications to felodipine, including taking any medication known to significantly interact with felodipine
7. Participant is currently taking a calcium channel blocking anti-hypertensive medication or has taken a calcium channel blocking anti-hypertensive medication within 12 weeks of the screening visit’
8. Known allergy to felodipine, any other dihydropyridine (due to theoretical risk of cross-hypersensitivity), or excipients of felodipine tablets
9. Presence of rare hereditary problem of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption as the felodipine tablets contain lactose
10. Participant is currently taking felodipine or has taken felodipine within 12 weeks of the screening visit
11. Female participant of childbearing potential who is unwilling or unable to use one highly effective method of contraception during the trial, as felodipine is not recommended to be taken during pregnancy (as per the BNF)
12. For the purpose of the trial, a woman is considered to be of childbearing potential following menarche until postmenopausal, unless surgically sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
13. Female participant who is pregnant or breastfeeding
14. Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks prior to the screening visit, or was enrolled in an interventional investigational trial within 4 weeks prior to screening
15. Any other significant disease, disability or investigation result which, in the opinion of the PI, may either put the participant at risk, or may influence the result of the trial, or the participant’s ability to participate in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of adverse events attributable to felodipine from baseline (week 0) to final visit measured using participant records and participant-reported events

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures