A Study of Ranolazine in ALS

Part of paid clinical trials in San Francisco, California.

Sponsor
Swathy Chandrashekhar, MBBS
Study ID
NCT06527222
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranolazine — DRUG
    500mg twice daily
  • Ranolazine — DRUG
    1000 mg twice daily
  • Placebo — DRUG
    Ranolazine placebo twice daily

Study Details

The purpose of this study is to evaluate safety, effect on cramps, function and quality of life of ranolazine versus placebo for the treatment of ALS.

Key Dates

Start date
Apr 29, 2025
Status verified
Jun 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranolazine low dose
    Participants receive Ranolazine 500mg orally twice daily for 24 weeks.
  • Experimental: Ranolazine high dose
    Participants receive Ranolazine 1000mg orally twice daily for 24 weeks.
  • Placebo Comparator: Placebo
    Participants receive Ranolazine placebo orally twice daily for 24 weeks.

Primary Outcome Measure

Frequency of Treatment-Emergent Adverse Events [ Time Frame: Up to 28 weeks ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Michael Han
415-353-7381
Swathy Chandrashekhar, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic FloridaJacksonvilleFlorida32224
Huy B. Tran
904-953-4503
Bjorn E Oskarsson, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterFairwayKansas66205
Nick Staudenmier, BS
913-945-9922
Katie Lillig, BS
913-945-9932
Jeffrey Statland, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical Center: WichitaWichitaKansas67214
KUMC CTSU Wichita
316-293-1833
Hannah Hancock
Matthew Byerly, MD (PRINCIPAL_INVESTIGATOR)
University of Missouri Health CareColumbiaMissouri65212
Amanda Heider
573-884-6852
William D Arnold, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Atchayah Balakrishna
Kaneshia Hives
Sarah Heintzman, CNP (PRINCIPAL_INVESTIGATOR)

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