World Health Organization site
Skip Navigation Links

Main
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.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02251457
Date of registration: 25/09/2014
Prospective Registration: Yes
Primary sponsor: Ohio State University
Public title: Study of Ranolazine in Myotonia Congenita, Paramyotonia Congenita and Myotonic Dystrophy Type 1
Scientific title: Open Label Trial of Ranolazine in Myotonia Congenita, Paramyotonia Congenita, & Myotonic Dystrophy Type 1
Date of first enrolment: August 2014
Target sample size: 35
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02251457
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     William D Arnold, MD
Address: 
Telephone:
Email:
Affiliation:  Ohio State University
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All
Health Condition(s) or Problem(s) studied
Myotonia Congenita
Myotonic Dystrophy 1
Paramyotonia Congenita
Intervention(s)
Drug: Ranolazine
Primary Outcome(s)
Electromyography (EMG) Myotonia [Time Frame: 1 month]
Muscle tasks [Time Frame: 1 month]
Questionnaires: Short Form Health Survey (SF-36) and Individualized Neuromuscular Quality of Life Questionnaire (INQoL) [Time Frame: 1 month]
Secondary Outcome(s)
Electrocardiogram (ECG) [Time Frame: 1 month]
Secondary ID(s)
IN-US-259-1605
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Gilead Sciences
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history