A Phase II Safety and Tolerability Study With SEN0014196
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01521585|
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : November 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Huntington's Disease||Drug: SEN0014196 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Placebo-controlled Study in Huntington's Disease Patients to Determine the Safety and Tolerability of SEN0014196|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
|Experimental: SEN0014196 50 mg oral tablet||
50 mg oral once daily tablet
|Experimental: SEN0014196 200 mg oral tablet||
200 mg oral once daily tablet
|Placebo Comparator: Placebo tablet||
oral once daily tablet
- Safety and tolerability [ Time Frame: 12 weeks ]Adverse event (AE) reporting, 12-lead electrocardiogram (ECG), vital signs, physical examination findings, and laboratory safety tests. Suicide risk (Columbia Suicide Severity Rating Scale,C-SSRS).
- Short-term clinical effects [ Time Frame: 12 weeks ]Global Clinical Impression (GCI, patient and clinician-based), UHDRS, Total Motor Scale (UHDRS-TMS), Functional Assessment, Independence Scale Assessment, Problem Behaviours Assessment, Cognitive Battery (Symbol Digit Modalities Test, Stroop Word Test, Verbal fluency, Mini-Mental State Examination [MMSE]).
- Modulation of candidate pharmacodynamic markers [ Time Frame: 12 weeks ]Acetylation status of mutant huntingtin, levels of soluble huntingtin.
- Pharmacokinetic profile [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521585
|Dept. of Neurology, University of Münster|
|Münster, Germany, 48149|
|Principal Investigator:||Ralf Reilmann, MD||Dept. of Neurology, University of Münster - Germany|