Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Sarah Tabrizi
ORCID ID
Contact details
University College London
London
WC1E 6BT
United Kingdom
-
apatel@ion.ucl.ac.uk
Additional identifiers
EudraCT number
2010-021563-32
ClinicalTrials.gov number
NCT01485952
Protocol/serial number
9944
Study information
Scientific title
A multicentre, multinational prospective observational imaging biomarker study in early stage Huntingtons disease (HD) patients to assess imaging techniques and parameters able to support efficacy studies with SEN0014196 in HD patients during Phase II and III studies
Acronym
SEN0014196
Study hypothesis
The study is an exploratory, multicentre, randomised and double blind placebo controlled, parallel group design at two dose levels with once daily administration over two weeks in clinical stages I-II of Huntingtons disease (HD) patients.
SEN0014196 is an investigational drug previously tested on healthy volunteers and will be tested for the first time on patients with HD. Previous studies in healthy volunteers have shown the drug to be safe and well tolerated. This study is expected to provide further information on how the compound works in humans and help further clinical development of SEN0014196. The study will be conducted at two different dose levels (10mg or 100mg of SEN0014196 given orally once daily) and there will also be a placebo arm. The study will assess what the drug does to the body (Pharmacodynamic effect) and what the body does to the drug (Pharmacokinetics). To do this repeated blood samples will be taken for the duration of the study. Safety assessments will also be conducted including ECGs, Blood Pressure, Pulse, Body Temperature, Laboratory Safety tests and a Physical Exam.
The total duration of the study is 28 days (14 days on treatment plus a 14 day Follow up Period), excluding the Screening period. 60 patients (males & females aged 18 to 70) with early stage HD will be involved in this study which will be conducted across 6 sites in the EU.
Ethics approval
10/H0803/169; First MREC approval date 07/02/2011
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Huntingtons Disease; Disease: Huntington's disease
Intervention
Repeated blood sampling, pharmacokinetic and pharmacodynamic measurements relating to study drug; study drug/placebo, safety and efficacy study of drug versus placebo; Study Entry : Single Randomisation only
Intervention type
Other
Phase
Phase I/II
Drug names
Primary outcome measure
Pharmacokinetic & pharmacodynamic blood sample analysis; Timepoint(s): various depending on study visit
Secondary outcome measures
Acute phenotypical effects; Timepoint(s): cognitive, motor, functional, behavioural and quality of life measures
Overall trial start date
11/04/2011
Overall trial end date
11/11/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with early Huntingtons Disease (aged 18 to 70 years), i.e. genetically confirmed (CAG repeat length = 36) HD, motor signs of HD (motor score of the Unified Huntington's Disease Rating Scale [UHDRS] > 5) and a Total Functional Capacity (TFC) of = 7
2. All patients will have a body weight greater than 50kg
3. Female subjects must be surgically sterile or postmenopausal (defined as at least two years post cessation of menses and/or follicular stimulating hormone >18 mIU/mL and serum oestradiol <110 pmol/L), no spontaneous menstruation for at least one year before the first dose, nonlactating and have a negative serum pregnancy test
[Note: For postmenopausal females treated with estrogen replacement therapy, folloicle stimulating hormones (FSH) levels are artificially lowered < 40 IU/L. Estradiol and Luteinizing hormone (LH) measurements need to be performed to confirm reason for low FSH value. Hormone replacement therapy (HRT) is acceptable, provided the above criteria are respected].
4. All subjects must be capable of providing written informed consent
5. Subjects must have no clinically significant and relevant history that could affect the conduct of the study and evaluation of the data, as ascertained by the Investigator through detailed medical history and screening assessments
6. Male subjects participating in the trial and their female partners must agree to use a highly effective method of contraception from the time of taking the first dose of the study drug until three months after taking the last dose. This must include a condom or other barrier method (i.e. a diaphragm or cervical/vault cap), with spermicidal cream/gel plus one extra method (i.e. established use of oral, injected or implanted hormonal contraception or IUD or Coil). If the female partner is already pregnant, use of condoms is mandatory during sexual intercourse from the time of taking the first dose of study drug until three months after taking the last dose of study drug.
Target Gender: Male & Female; Upper Age Limit 70 years ; Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 60; UK Sample Size: 20; Description: Early stage Huntington's disease
Participant exclusion criteria
1. Participation in a study of an investigational drug within 30 days of the baseline visit
2. Subjects with presence of psychosis and/or confusional states
3. Subjects with clinically significant laboratory or electrocardiogram (ECG) abnormalities at screening
4. Subjects with clinically relevant haematological, hepatic, cardiac or renal disease
5. A medical history of infection with Human immunodeficiency virus, Hepatitis C and/or Hepatitis B
6. Any relevant condition, behaviour, laboratory value or concomitant medication which, in the opinion of the Investigator, makes the subject unsuitable for entry into the study
7. Subjects who have previously received histone deacetylase inhibitors e.g. vorinostat (Zolinza®) or have participated in a clinical trial using a histone deacetylase inhibitor
8. A history of malignancy of any type within 2 years prior to screening. A history of surgically excised nonmelanoma skin cancers is permitted
9. Subjects with a significant history of drug allergy as determined by the Investigator
10. Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week or who have a significant history of alcoholism or drug/ chemical abuse as determined by the Investigator (one unit of alcohol equals 285 mL of beer or lager, one glass [125 mL] of wine, or 25 mL of spirits)
Recruitment start date
11/04/2011
Recruitment end date
11/11/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
London
WC1E 6BT
United Kingdom
Funders
Funder type
Government
Funder name
Seventh Framework Programme
Alternative name(s)
EC Seventh Framework Programm, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, EU 7th Framework Programme, European Union 7th Framework Programme, FP7
Funding Body Type
government organisation
Funding Body Subtype
federal/national government
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25223731