- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02269436
A follow-on Study to Assess Long-term Safety and Tolerability of i.c.v Administration of sNN0029 in Patients With ALS
A Multi-centre, Open-label, follow-on Study to Assess Long-term Safety and Tolerability of Intracerebroventricular Administration of sNN0029 in Patients With Amyotrophic Lateral Sclerosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is an open-label, follow-on phase 1 study to assess the long-term safety and tolerability of continuous i.c.v administration of sNN0029 infusion solution in patients with ALS.
Eighteen patients who previously participated in study sNN0029-003 will receive continuous administration of 4 μg sNN0029/day via i.c.v. infusion with the Medtronic SynchroMed® II Infusion System. The sNN0029 infusion solution is intended to be an add-on treatment to other treatments for ALS.
The assessments performed at the last visit in study sNN0029-003 will serve as the baseline values for patients included in study sNN0029-004 and be the start of sNN0029 treatment for all patients (Study Day 1; Visit 1). In order to not reveal the blind in study sNN0029-003, the patients will return to hospital on Day 3 and stay to Day 6 (Visit 2). During these days, the sNN0029 begins to exit the i.c.v. catheter tip in the ventricle of the brain.
Patients will return to the hospital on Day 11 (Visit 3) for a refill of sNN0029 and adjustment of the infusion pump flow rate. After this, the patient will return to the clinic on Day 39 (Visit 4) for a sNN0029-refill of infusion pump and assessments. Thereafter the patients will visit the hospital on a monthly basis (every 28 days ± 2) to perform refills and make assessments every 3 months.
Treatment in study sNN0029-004 may continue unless safety concerns warrant discontinuation of therapy, until patients choose to withdraw from the study, experience treatment related toxicity or intolerance, are deemed to be unsuitable to continue treatment by the investigator, or die
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Leuven, Belgium, B-3000
- Philip Van Damme
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Utrecht, Netherlands, NL-3508
- Leonard van den Berg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Previous participation in sNN0029-003 with completion of 12 weeks study without clinically significant safety concerns
- Intact continuity of the Medtronic SynchroMed® II Infusion System as judged by X-ray of head and abdominal area
- Clinical diagnosis of ALS classified as definite, or probable with or without additional laboratory evidence, according to the revised WFN El Escorial criteria
- 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
- 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 informed consent form on the patient's behalf
Exclusion Criteria:
- Hypertension defined as blood pressure >160 mmHg systolic or >90 mmHg diastolic
- Ophthalmological examination (fundus photography, visual acuity and perimetry) with any clinically significant findings that imply safety concerns for this study.
- Diagnosis of diabetes mellitus
Presence of risk for increased or uncontrolled bleeding and/or risk of bleeding that cannot be not managed optimally due to:
- Anatomical factors at or near the implant site (e.g., vascular abnormalities, neoplasms, or other abnormalities)
- Underlying disorders of the coagulation cascade, platelet function, or platelet count (e.g., haemophilia, Von Willebrand's disease, liver disease, or other medical conditions)
- Presence of additional risk factors for thromboembolism such as obesity (Body mass index [BMI] > 35) or use of oestrogens including combined contraceptive pills
- Clinically significant abnormalities in haematology or clinical chemistry parameters as assessed by the investigator
- Ongoing medical condition that according to the investigator would interfere with the conduct and assessments in the study. Examples are medical disability (e.g., severe degenerative arthritis, compromised nutritional state, peripheral neuropathy) that would interfere with the assessment of safety and efficacy of investigational product or device performance, or would compromise the ability of the patient to undergo study procedures (e.g., MRI), or to give informed consent
For women only: pregnant, breast feeding and/or for fecund women unwillingness to use adequate contraception during the trial such as:
- Established use of oral, injected or implanted hormonal methods of contraception that do NOT contain oestrogens
- Placement of an intrauterine device
- Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: sNN0029 infusion solution
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4 µg/day, continuous i.c.v administration
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number Patients with Adverse Events as a measure of Safety and Tolerability
Time Frame: At 24 Months
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Number of patients with events will be analysed primarily at 24 months of study duration.
The study may be extended on a 6-monthly basis for as long as there are patients that tolerate, and are still eligible to receive, the study treatment.
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At 24 Months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sNN0029-004
- 2012-005034-11 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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