Interventional {{label}}

Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)

Please note: All trial information reflects the latest data available from the sponsor on ClinicalTrials.gov and other public databases. However, these sources may occasionally be outdated or inaccurate. For the most current information, we recommend contacting the trial sponsor or sites directly.

Overview

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Approved by FDA
Approved outside USA
Is a supplement

Details

Enrollment Criteria

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This is an open-label, multi-center study designed to extend the evaluation of the safety, tolerability, and clinical effects of oral administration of KNS-760704 in patients with ALS.

Patients who complete the Part 2 Week 28 visit in study KNS-760704-CL201 and patients with ALS who were actively receiving RTPB [(6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine dihydro-chloride monohydrate] under Research IND #60,948 were eligible to participate in this study. Eligible patients received 1 tablet of KNS-760704 (150 mg) every 12 hours (Q12H) (300 mg total daily dose) for up to 180 weeks.

Inclusion Criteria:
1. Patient has provided signed informed consent for this trial before the commencement of
any study-related procedure
2. Patient is actively participating in Knopp Protocol KNS-760704-CL201 and has completed
the Part 2 Week 28 visit in that study or patient is actively receiving RTPB under
Research IND #60,948
Exclusion Criteria:
1. Patient did not participate in Knopp Protocol KNS-760704-CL201 or patient did not
receive RTPB under Research IND #60,948.
2. Patient discontinued from KNS-760704-CL201 for any reason other than enrollment into
this study (applies to patients enrolled in KNS-760704-CL201 only)
3. Patient was not taking RTPB under Research IND #60,948 prior to April 30, 2009
(applies to patients enrolled under Research IND #60,948 only)

Locations
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