A longitudinal study in Huntington’s Disease
Research type
Research Study
Full title
A MULTI-SITE, PROSPECTIVE, LONGITUDINAL, COHORT STUDY MEASURING CEREBROSPINAL FLUID-MUTANT HUNTINGTIN PROTEIN IN PATIENTS WITH HUNTINGTON’S DISEASE
IRAS ID
251325
Contact name
Sarah Tabrizi
Contact email
Sponsor organisation
F.Hoffmann-LaRoche Ltd
Clinicaltrials.gov Identifier
2018-000632-98, EUDRACT NUMBER
Duration of Study in the UK
1 years, 10 months, days
Research summary
The study is designed as a multi-site, prospective, 15-month longitudinal, cohort study measuring the abnormal mutant huntingtin protein CSF mHTT in patients with early manifest Stage I or Stage II HD. After study completion, participants will be eligible to enroll in an OLE study with active RO7234292 compound, provided the data from the ongoing RO7234292 program support continued development and subject to approval by the relevant competent authorities and Ethics Committees (ECs). \n\nThis study will enroll up to approximately 100 patients with early manifest Stage I or II HD at approximately 20 sites. After a 28-day screening period, patients will return to the clinic at baseline and at Months 3, 9, and 15. During these visits, patients will receive clinical, MRI, and Roche HD mobile app assessments; they will also provide CSF and blood samples. A post-observational follow-up visit will take place 2 weeks after the 15-month longitudinal period and may occur by telephone or in the clinic. \n\nEarly termination visits should take place via clinic visit, where possible.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
18/LO/1763
Date of REC Opinion
11 Dec 2018
REC opinion
Further Information Favourable Opinion