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| Sponsored by: |
Knopp Neurosciences |
|---|---|
| Information provided by: | Knopp Neurosciences |
| ClinicalTrials.gov Identifier: | NCT00647296 |
Purpose
This is a 2-part study of KNS-760704 in patients with ALS.
| Condition | Intervention | Phase |
|---|---|---|
|
Amyotrophic Lateral Sclerosis |
Drug: KNS-760704 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
| Official Title: | A 2-Part, Randomized, Double-Blind, Safety and Tolerability Study Evaluating KNS-760704 in Patients With Amyotrophic Lateral Sclerosis (ALS) |
| Enrollment: | 102 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
placebo: Placebo Comparator
placebo treatment Q12H
|
Drug: KNS-760704
placebo, low-dose of KNS-760704, mid-dose of KNS-760704, high-dose of KNS-760704
|
|
low-dose KNS-760704: Experimental
low-dose KNS-760704
|
Drug: KNS-760704
placebo, low-dose of KNS-760704, mid-dose of KNS-760704, high-dose of KNS-760704
|
|
mid-dose KNS-760704: Experimental
mid-dose KNS-760704
|
Drug: KNS-760704
placebo, low-dose of KNS-760704, mid-dose of KNS-760704, high-dose of KNS-760704
|
|
high-dose KNS-760704: Experimental
high-dose KNS-760704
|
Drug: KNS-760704
placebo, low-dose of KNS-760704, mid-dose of KNS-760704, high-dose of KNS-760704
|
This is a double-blind, randomized, placebo-controlled study evaluating the safety and efficacy of KNS-760704 compared to placebo. The study will be conducted in 2 parts.
In Part 1, approximately 80 eligible patients will be randomized to 1 of 4 treatment groups for 12 weeks of treatment: placebo; low-dose; mid-dose; or high-dose KNS-760704. Participants meeting eligibility requirements will be enrolled at approximately 20 centers in the U.S. In addition to the visit to determine eligibility and the first visit to take study drug, participants will be required to make 5 additional research clinic visits in Part 1.
Participants who complete all 12 weeks of Part 1 will be eligible for randomization to Part 2. The duration of Part 2 of the study is 76 weeks. Subjects will receive 1 of 2 active treatment groups for 72 weeks (low-dose or high-dose KNS-760704) and placebo for the remaining 4-week period in Part 2.
Participants will not be told when the 4 weeks of placebo treatment will be given. During Part 2, participants will be required to make 12 research clinic visits, including the baseline visit.
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 21 Study Locations| Study Director: | Evan Ingersoll, Ph.D. | Knopp Neurosciences Inc. |
More Information
| Responsible Party: | Knopp Neurosciences Inc. ( Jim Mather / Sr. Director, Clinical Development ) |
| Study ID Numbers: | KNS-760704-CL201 |
| Study First Received: | March 26, 2008 |
| Last Updated: | November 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00647296 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
ALS Amyotrophic Lateral Sclerosis Lou Gehrig Lou Gehrig's |
Lou Gehrig's disease Motor Neuron Disease Nervous System Diseases KNS-760704 |
|
Neurotransmitter Agents Antioxidants Spinal Cord Diseases Central Nervous System Diseases Sclerosis Neurodegenerative Diseases Dopamine Agonists Pramipexol |
Dopamine Neuromuscular Diseases Lou Gehrig's Disease Amyotrophic Lateral Sclerosis Dopamine Agents Motor Neuron Disease Degenerative Motor System Disease |
|
Neurotransmitter Agents Antioxidants Spinal Cord Diseases Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Nervous System Diseases Antiparkinson Agents Central Nervous System Diseases Sclerosis Dopamine Agonists |
Neurodegenerative Diseases Protective Agents Pramipexol Pharmacologic Actions Pathologic Processes Neuromuscular Diseases Amyotrophic Lateral Sclerosis Therapeutic Uses Dopamine Agents Central Nervous System Agents Motor Neuron Disease |