A follow-on Study to Assess Long-term Safety and Tolerability of i.c.v Administration of sNN0029 in Patients With ALS
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|ClinicalTrials.gov Identifier: NCT02269436|
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 : October 21, 2014
Last Update Posted : January 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Drug: sNN0029 infusion solution||Phase 1|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 Start Date :||January 2015|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
|Experimental: sNN0029 infusion solution||
Drug: sNN0029 infusion solution
4 µg/day, continuous i.c.v administration
- Number Patients with Adverse Events as a measure of Safety and Tolerability [ Time Frame: At 24 Months ]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.
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): NCT02269436
|Philip Van Damme|
|Leuven, Belgium, B-3000|
|Leonard van den Berg|
|Utrecht, Netherlands, NL-3508|