NCT01485952

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

An Exploratory Clinical Trial in Early Stage Huntington's Disease Patients to Assess Pharmacokinetics, Candidate Pharmacodynamic Measures of Target Engagement and Disease Modulation as Well as Acute Phenotypical Effects Following Multiple Oral Doses of SEN0014196.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Siena Biotech S.p.A. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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

• Huntington Disease

Interventions

Type	Name	Description
DRUG	SEN0014196 (Low Dose)	10 mg once daily administration (immediate release capsule)
DRUG	SEN0014196 (High Dose)	100 mg once daily administration (immediate release capsule)
DRUG	Placebo	Once daily administration (immediate release capsule)

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-12-06
• Last updated: 2015-11-25

Locations

1 site across 1 country: Germany