Trial intelligence / Profile preview

Selisistat Safety and Tolerability in Huntington's Disease

NCT01521585Phase 2

Key facts

Status: Completed
Start: Nov 2011
Primary completion: Oct 2012
Countries: 1
Sponsor: Siena Biotech
Modality: Small Molecules

Drugs: Selisistat
Conditions: Huntington's disease (HD)

Overview

Phase 2, randomised, double-blind trial of Selisistat in Huntington's disease (HD) (3 arms), sponsored by Siena Biotech. Primary endpoint: Safety and tolerability at 12 weeks. Started Nov 2011; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

SEN0014196 50 mg
SEN0014196 50 mg oral once daily tablet
SEN0014196 200 mg
SEN0014196 200 mg oral once daily tablet
Placebo
Placebo oral once daily tablet

Who it enrols

Patients with genetically confirmed, manifest Huntington's Disease (CAG >= 36), motor signs (UHDRS >= 5), and functional capacity (TFC >= 3), aged 30-70.

Endpoints

Primary

Safety and tolerability12 weeks

Secondary

Short-term clinical effects12 weeks
Modulation of candidate pharmacodynamic markers12 weeks
Pharmacokinetic profile12 weeks

Beyond the preview

Go deeper on NCT01521585.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01521585.