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An Open Label, Safety and Tolerability Continuation Study of Intracerebroventricular Administration of sNN0029 to Patients With Amyotrophic Lateral Sclerosis

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: NCT01384162
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 : June 28, 2011
Last Update Posted : January 27, 2016
Sponsor:
Collaborators:
Medtronic
ICON Clinical Research
Information provided by (Responsible Party):
Newron Sweden AB

Study Description
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Brief Summary:
This is an open label safety and tolerability continuation study of intracerebroventricular administration of sNN0029, containing the growth factor VEGF165, in patients with amyotrophic lateral sclerosis that have previously participated in study sNN0029-001. The intention of the study is to investigate safety and tolerability of intracerebroventricular administration of sNN0029 and whether it can improve motor function and prolong survival in patients with ALS.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: sNN0029 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Safety and Tolerability Continuation Study of Intracerebroventricular Administration of sNN0029 to Patients With Amyotrophic Lateral Sclerosis, Using an Implanted Catheter and SynchroMed® II Pump
Study Start Date : June 2009
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: sNN0029, ICV infusion Drug: sNN0029
ICV infusion


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability through assessments of adverse events, vital signs, clinical laboratory tests, MRI of brain, fundus photography and device performance as characterized by catheter tip placement and infusion accuracy [ Time Frame: multiple assessments over 120 weeks ]

Secondary Outcome Measures :
  1. Disease activity as measured by ALS functional rating scale (FRS) - VEGF concentrations in CSF - Possible VEGF antibodies in plasma [ Time Frame: Multiple assessments over 120 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of ALS classified as definite, or probable with or without additional laboratory evidence, according to the revised WFN El Escorial criteria (Appendix B).
  2. Previous participation in study sNN0029-001 with completion of 12 weeks study drug administration.
  3. To have completed the investigations associated with safety in study sNN0029-001 without development of clinically significant safety concerns.
  4. Patient has been given written and verbal information about the continuation study, has had the opportunity to ask questions about the study, and understands the time and procedural commitments.
  5. Patient has given oral and / or signed consent (written) to participate in the study. In the event that a patient who gives oral informed consent is not physically able to sign the informed consent form (ICF) due to disease progression, a witness may sign the ICF on the patient's behalf.

Exclusion Criteria:

  1. Hypertension defined as blood pressure >160 mmHg systolic or >90 mmHg diastolic.
  2. Proliferative retinopathy.
  3. Non-proliferative retinopathy of moderate severity or higher.
  4. Concurrent clinically significant dementia as determined by the investigator.
  5. Concurrent clinically significant depression as determined by the investigator.
  6. Need for administration of any antiplatelet or anticoagulant medication (e.g. aspirin, Plavix, non-steroidal anti-inflammatory drugs [NSAIDs]). Low dose aspirin or occasional use of NSAIDs is allowed (See Appendix E).
  7. Clinically significant abnormalities in haematology or clinical chemistry parameters as assessed by the investigator.
  8. For female patients, ongoing pregnancy or planned pregnancy
  9. Breast feeding
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01384162


Locations
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Belgium
University Hospital Leuven, Department of Neurology
Leuven, Belgium, 3000
Sponsors and Collaborators
Newron Sweden AB
Medtronic
ICON Clinical Research
Investigators
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Principal Investigator: Wim Robberecht, MD, PhD University Hospital Leuven, Department of Neurology
More Information
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Responsible Party: Newron Sweden AB
ClinicalTrials.gov Identifier: NCT01384162    
Other Study ID Numbers: sNN0029-002
First Posted: June 28, 2011    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Keywords provided by Newron Sweden AB:
ALS
VEGF165
Safety
 Intracerebroventricular
Infusion
Implantable
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases