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Sodium Channel Blocker
Ranolazine 500mg for Lou Gehrig's Disease
Phase 2
Recruiting
Led By Jeffrey Statland, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 2, 6, and 8
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This trial will study whether Ranolazine is safe and effective for treating ALS patients.
Eligible Conditions
- Lou Gehrig's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 2, 6, and 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 2, 6, and 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose limiting toxicities (DLT)
Secondary study objectives
Cramp Questionnaire
Cramp potential duration
Fasciculation frequency on muscle ultrasound
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Ranolazine 500mgExperimental Treatment1 Intervention
Participants will take Ranolazine 500mg twice daily for up to 4 weeks.
Group II: Ranolazine 1000mgExperimental Treatment1 Intervention
Participants will take Ranolazine 1000mg twice daily for up to 4 weeks.
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
510 Previous Clinical Trials
176,875 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,134 Previous Clinical Trials
867,939 Total Patients Enrolled
Jeffrey Statland, MDPrincipal InvestigatorUniversity of Kansas Medical Center
5 Previous Clinical Trials
1,296 Total Patients Enrolled
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