Condition category
Nervous System Diseases
Date applied
07/06/2011
Date assigned
07/06/2011
Last edited
10/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.paddingtonproject.eu

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

Protocol/serial number

9944

Study information

Scientific title

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 Huntington’s 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

Condition

Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Huntington’s 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 measures

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

Eligibility

Participant inclusion criteria

1. Patients with early Huntington’s 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

Sponsor information

Organisation

Siena Biotech (Italy)

Sponsor details

ddress 35
Strada del Petriccio e Belriguardo
Siena
53100
Italy

Sponsor type

Industry

Website

Funders

Funder type

Government

Funder name

European Union (EU) (Belgium) - Seventh Framework Programme (FP7)

Alternative name(s)

Funding Body Type

Funding Body Subtype

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes