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 of sNN0029 in ALS patients.

ewron Sweden AB0 sites9 target enrollmentTBD

ConditionsALS Lou Gehrig's disease 10029305 10009720

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ALS
Sponsor: ewron Sweden AB
Enrollment: 9
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Trial ended prematurely

Registry

who.int

Start Date

TBD

End Date

October 30, 2015

Last Updated

last year

Study Type

Interventional

Investigators

Sponsor

ewron Sweden AB

Eligibility Criteria

Inclusion Criteria

•1\. Ability to understand and provide written informed consent to participate in the trial before any trial\-related procedures are conducted.
•2\. Clinical diagnosis of ALS classified as definite, or probable with or without additional laboratory evidence, according to the revised World Federation of Neurology (WFN) El Escorial criteria.
•3\. Male or female aged 18 to 75 years inclusive.
•4\. If patients are being treated with riluzole, they must have been on a stable dose for at least the past 30 days prior to screening.
•5\. The patient is, in the opinion of the investigator, medically fit to undergo the surgery required for stereotactic implantation of the catheter and infusion pump.

Exclusion Criteria

•1\. Impaired respiratory function judged to pose a risk to the patient during anaesthesia for the device implantation.
•2\. Hypertension defined as blood pressure \>160 mmHg systolic or \>90 mmHg diastolic.
•3\. Values for coagulation parameters including platelet count, normalised prothrombin complex (PK\-INR), activated partial thromboplastin time (APTT) outside normal ranges.
•4\. Ophthalmological examination including fundus photography, visual acuity by Early Treatment in Diabetic Retinopathy Study (ETDRS) and perimetry, with any clinically significant findings that imply safety concerns for this study.
•5\. Diagnosis of diabetes mellitus.
•6\. History of structural brain disease other than ALS, including tumours and hyperplasia.
•7\. An MRI of the brain and cervical spine, and an MRA of the brain with findings of tumours or potential sources of pathological bleedings, or abnormality that may interfere with the assessments of safety or efficacy or that would, in the judgment of the investigator, represent a surgical risk to the patient. If an MRI and/or MRA has been performed within 1 month prior to screening, the results from that examination can be used.
•8\. Any disorder that precludes a surgical procedure (e.g., signs of sepsis or inadequately treated infection), alters wound healing (e.g., including bleeding disorders), or renders chronic i.c.v. delivery or device implants medically unsuitable.
•9\. Presence of risk for increased or uncontrolled bleeding and/or risk of bleeding that cannot be not managed optimally due to:
•i. anatomical factors at or near the implant site (e.g., vascular abnormalities, neoplasms, or other abnormalities),