CompletedNCT01485952PADDINGTONUpdated Nov 25, 2015

An Exploratory Clinical Trial in Early Stage Huntington's Disease Patients With SEN0014196

A Phase 1 interventional study of SEN0014196 (Low Dose) and SEN0014196 (High Dose) in Huntington Disease, sponsored by Siena Biotech S.p.A.. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-11-25.

Sponsored by Siena Biotech S.p.A. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 55
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

The primary objective of this study is to provide biological samples from patients with Huntington's disease to allow characterisation of the pharmacological mechanism of action of SEN0014196.

Read the detailed description

This study will establish the acute phenotypical and biological effects of repeated dose application of SEN0014196 in patients with Huntington's disease, providing biomaterials for biomarker studies (levels of circulating huntingtin, acetylation status of mutant huntingtin, innate immune markers, transcriptional profiles). Evaluation of phenotypic effects will include UHDRS scores, total functional capacity. Safety assessments will include ECG, vital signs, laboratory safety tests and physical examination.

Conditions studied

Huntington Disease

Browse trials for

Huntington Disease 285

Keywords

Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Mental Disorders

In context

Huntington Disease

285 studies on the registry are indexed under Huntington Disease; 49 are open to participants now.

This study's enrollment of 55 is above the median of 40 across 203 interventional studies indexed under Huntington Disease.

Browse Huntington Disease studies →

Lead sponsor

Siena Biotech S.p.A. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients with early Huntington's Disease (age: 18 to 70 years), i.e. genetically confirmed (CAG repeat length ≥36) HD, motor signs of HD (motor score of the UHDRS > 5) and a TFC of ≥7.
All patients will have a body weight greater than 50 kg.
Female subjects must be surgically sterile or post-menopausal, no spontaneous menstruation for at least one year before the first dose, non-lactating and have a negative urine pregnancy test. Male subjects participating in the trial and their female 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.
All subjects must be capable of providing written informed consent.
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.

Exclusion criteria

Exclusion Criteria:

Participation in a study of an investigational drug within 30 days of the baseline visit.
Subjects with presence of psychosis and/or confusional states.
Subjects with clinically significant laboratory or ECG abnormalities at Screening.
Subjects with clinically relevant hematological, hepatic, cardiac or renal disease.
A medical history of infection with human immunodeficiency virus, hepatitis C and/or hepatitis B.
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.
Subjects who have previously received histone deacetylase inhibitors e.g. vorinostat or have participated in a clinical trial using compound suspected of interfering with protein acetylation status.
A history of malignancy of any type within 2 years prior to screening. A history of surgically excised nonmelanoma skin cancers is permitted.
Subjects with a significant history of drug allergy as determined by the Investigator.
Subjects who have a significant history of alcoholism or drug/chemical abuse as determined by the Investigator.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 55 participants (actual)

Study arms

Experimental
SEN0014196 (Low Dose)
10 mg, once daily administration (immediate release capsule)
Drug: SEN0014196 (Low Dose)
Experimental
SEN0014196 (High dose)
100 mg, once daily administration (immediate release capsule)
Drug: SEN0014196 (High Dose)
Placebo comparator
Placebo
Once daily (immediate release capsule)
Drug: Placebo

Interventions

DrugSEN0014196 (Low Dose)
10 mg once daily administration (immediate release capsule)
DrugSEN0014196 (High Dose)
100 mg once daily administration (immediate release capsule)
DrugPlacebo
Once daily administration (immediate release capsule)

What researchers measure

Primary outcomes

To determine the change from baseline of a series of pharmacodynamic markers in peripheral blood mononuclear cells
Collection of peripheral blood mononuclear cells for biomarker investigations, specifically acetylation status of mutant huntingtin, levels of circulating huntingtin, innate immune markers and transcriptional profiles
Time frame: Baseline, Day 7, Day 14, Follow-Up

Secondary outcomes

To determine the safety and tolerability following repeated doses of SEN0014196 over two weeks at two dose levels in patients with Huntington's disease
Safety assessments will include ECG, vital signs, laboratory safety tests, and physical and neurological examination. Tolerability will include type and frequency of adverse events.
Time frame: Baseline, Day 7, Day 14, Follow-up
To determine the pharmacokinetics of repeated doses of SEN0014196 at two dose levels when administered over two weeks in patients with Huntington's disease
The following parameters will be assessed: maximum observed plasma concentration (Cmax), time of maximum observed plasma concentration(tmax), AUC from time zero to the length of the dosing interval (tau) (AUC0-τ), AUC from time zero to the last quantifiable concentration (AUC0-last), AUC from time zero to infinity (AUC0-∞), terminal elimination half-life (t1/2), and terminal elimination rate constant (λz). Gender differences. Dose proportionality.
Time frame: Baseline, Day 14

Study locations

1 site

Universitätsklinik Ulm, Neurologie
Ulm, 89081, Germany

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01485952
Lead sponsor: Siena Biotech S.p.A.
Collaborators: Seventh Framework Programme, European Huntington's Disease Network
Responsible party: Sponsor
First posted: Dec 6, 2011
Start date: Mar 2011
Primary completion: Nov 2011
Completion: Nov 2011
Last update: Nov 25, 2015

Study contacts

Bernhard G Landwehrmeyer, MD, PhD

principal investigator · European Huntington's Disease Network

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Huntington Disease→

Other studies from this sponsor

Siena Biotech S.p.A.

Start the discussion