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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2018 |
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Main ID: |
NCT00931944 |
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Date of registration:
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30/06/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)
CL211 |
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Scientific title:
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An Open-Label, Safety and Tolerability, Study Evaluating KNS-760704 in Patients With Amyotrophic Lateral Sclerosis (ALS) |
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Date of first enrolment:
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July 2009 |
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Target sample size:
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74 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00931944 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Merit Cudkowicz, M.D., MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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NeuroClinical Trials Unit (Massachusetts General Hospital) |
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Key inclusion & exclusion criteria
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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)
Age minimum:
21 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: KNS-760704
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Primary Outcome(s)
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The primary objective of the study is to extend the evaluation of long-term safety and tolerability of KNS-760704 300 mg daily.
[Time Frame: 180 weeks]
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Secondary Outcome(s)
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The secondary objective of the study is to evaluate the long-term effects of KNS-760704 300 mg daily on measures of clinical function.
[Time Frame: 180 weeks]
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Secondary ID(s)
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KNS-760704-CL211
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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