Status:
COMPLETED
Study of Ranolazine in Myotonia Congenita, Paramyotonia Congenita and Myotonic Dystrophy Type 1
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Gilead Sciences
Conditions:
Myotonia Congenita
Paramyotonia Congenita
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to gather preliminary data to determine if ranolazine is a safe and effective treatment for the symptoms of myotonia congenital, paramyotonia congenita, and myotonic dystr...
Detailed Description
Recent advances in the understanding of myotonia congenita have identified potential areas that could possibly respond to treatment in a drug study. The drug ranolazine (trade name Ranexa) is a FDA-ap...
Eligibility Criteria
Inclusion
- Diagnosis of myotonia congenital, paramyotonia congenital or Myotonic Dystrophy Type 1 established by genetic testing in the subject or in a first-degree relative.
- Clinically evident myotonia
Exclusion
- Contraindications to ranolazine use:
- for fungus infection: ketoconazole (Nizoral), itraconazole (Sporanox, Onmel)
- for infection: clarithromycin (Biaxin)
- for depression: nefazodone
- for HIV: nelfinavir (Viracept), ritonavir (Norvir), lopinavir and ritonavir (Kaletra), indinavir (Crixivan), saquinavir (Invirase).
- for tuberculosis (TB): rifampin (Rifadin), rifabutin (Mycobutin), rifapentine (Priftin)
- for seizures: phenobarbital, phenytoin (Phenytek, Dilantin, Dilantin-125), carbamazepine (Tegretol)
- the herbal supplement St. John's wort
- you have scarring (cirrhosis) of your liver
- Concurrent use of mexiletine, lacosamide, acetazolamide, phenytoin, quinine, procainamide, Saint John wort or tocainide. Patients who were previously treated with these medications may participate. They need to be off of the medication for at least a week prior to enrollment.
- QTc \>470 ms for men and \>480 ms for women.
- Women who are pregnant or breastfeeding
- Direct family history of sudden cardiac death
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2017
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02251457
Start Date
August 1 2014
End Date
December 18 2017
Last Update
March 5 2019
Active Locations (1)
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1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43221