A Safety Study of sNN0029 Administration Via Intracerebroventricular Route to Patients With ALS
|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: NCT01999803|
Recruitment Status : Terminated (Issues with development and supply of infusion system for delivery of IMP. Lack of favorable benefit risk ratio in sNN0029-003 study (review of interim data).)
First Posted : December 3, 2013
Last Update Posted : January 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Drug: sNN0029 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase I, Randomised, Double-blind, Placebo-controlled Study in Patients With Amyotrophic Lateral Sclerosis to Further Assess the Safety and Tolerability of Intracerebroventricular Administration of sNN0029 Infusion Solution|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: sNN0029 (VEGF)
4 µg/d of sNN0029 administered by continuous intracerebral infusion during12 weeks
Other Name: telbermin, rhVEGF165
Placebo Comparator: Placebo
Placebo administered by continuous intracerebral infusion during12 weeks
Other Name: Artificial CSF
- Number of Adverse Events (AEs) [ Time Frame: 12 weeks ]The safety and tolerability of i.c.v. administration of sNN0029 infusion solution at a dose of 4 µg/day delivered via a Medtronic SynchroMed® II Infusion System will be evaluated by comparing tabulated number of events over 12 weeks by body system, preferred term and by severity and relationship to study medication/device. Serious Adverse Events/Serious Adverse Device Events will also be presented in separate tabulations.
- VEGF165 levels in Cerebrospinal Fluid (CSF) [ Time Frame: 12 weeks ]Levels of the active ingredient of sNN0029 infusion solution (VEGF165) in CSF will be summarised using descriptive statistics by time point and treatment.
- Medical Device performance [ Time Frame: 12 weeks ]Device performance (number of values +/-25% of expected) will be presented by time point and treatment.
- ALS Functional Raring Scale - Revised (ALSFRS-R) [ Time Frame: 12 weeks ]ALSFRS-R score (0=worst to 48=best) will be analysed as absolute value and as change from baseline using descriptive statistics by time point and treatment.
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): NCT01999803
|Philip Van Damme|
|Leuven, Belgium, B-3000|
|Leonard van den Berg|
|Utrecht, Netherlands, NL-3508|
|Principal Investigator:||Philip VanDamme, Prof, MD||University Hospital Leuven, Herestraat 49, B-3000 Leuven, Belgium|
|Principal Investigator:||Leonard van den Berg, MD, Prof||University Medical Center Utrecht, Department of Neurology G03.228, P.O. Box 85500, NL-3508 GA Utrecht, The Netherlands|