Hyper- and Hypokalemic Periodic Paralysis Study
Completed · Phase 3 · Has a placebo group
Conditions studied: Hyperkalemic Periodic Paralysis, Hypokalemic Periodic Paralysis
In brief
The purpose of this study is to compare Dichlorphenamide with placebo (an inactive substance) for prevention of episodes and for improvement of strength in hyperkalemic (HYP) and hypokalemic (HOP) periodic paralysis. This study will also look at the long-term effects of Dichlorphenamide in periodic paralysis.
Key facts
- Study ID
- NCT00494507
- Run by
- University of Rochester
- People needed
- 71
- Starts
- 2007-06-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2017-06-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Genetically definite, clinically definite or clinically probable Hyperkalemic or Hypokalemic Periodic Paralysis as outlined in the protocol
- Male and female participants, age 18 and older who are able to comply with the study conditions.
- Participants who have distinct regular episodes of weakness with an average frequency of > or = to 1 a week and < or = to 3 a day either on or off treatment, whichever is higher
- Normal thyroid-stimulating hormone (TSH) level
You may not qualify if…
- Evidence for Andersen-Tawil syndrome (any one of the following 3 criteria)
- Prolonged QT interval or complex ventricular ectopy between attacks
- Distinctive physical features (2 of the following 5)
- Low set ears
- Short stature
- Hypo-/micrognathia
- Clinodactyly
- Hypo-/hypertelorism
- KIR 2.1 gene mutation
- Coincidental renal, hepatic, active thyroid disease, restrictive or obstructive lung disease, other neuromuscular disease, or heart disease
- Chronic, non-congestive, angle-closure glaucoma
- Use of any of the following medications for reasons other than treatment of periodic paralysis: diuretics, antiarrhythmics, corticosteroids, beta-blockers, calcium channel blockers, antiepileptics, magnesium
- History of life-threatening episodes of respiratory muscle weakness or cardiac arrhythmias during attacks
- Pregnancy
- Known mutation in the alpha subunit of the sodium channel gene in hypokalemic periodic paralysis patients
Where it is running
- UCLA Neurology — Los Angeles, California, United States
- University of California-San Francisco — San Francisco, California, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Brigham & Women's Hospital — Boston, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Columbia University Medical Center — New York, New York, United States
- University of Rochester — Rochester, New York, United States
- Ohio State University — Columbus, Ohio, United States
- University of Texas Southwestern-Dallas — Dallas, Texas, United States
- University of Milan — San Donato, Milan, Italy
- Institute of Neurology-Queen's Square — London, United Kingdom
Full record on ClinicalTrials.gov
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