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

NCT ID: NCT01384162

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2015-10-31

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sNN0029, ICV infusion

Group Type: EXPERIMENTAL

sNN0029

Intervention Type: DRUG

ICV infusion

Interventions

sNN0029

ICV infusion

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

ICON Clinical Research

INDUSTRY

Sponsor Role: collaborator

Newron Sweden AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wim Robberecht, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Leuven, Department of Neurology

Locations

University Hospital Leuven, Department of Neurology

Leuven, , Belgium

Countries

Belgium

Other Identifiers

sNN0029-002

Identifier Type: -

Identifier Source: org_study_id