Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
71 participants
INTERVENTIONAL
2007-06-30
2013-05-31
Brief Summary
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Detailed Description
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In this multi-center, parallel, randomized trial researchers will compare the effects of dichlorphenamide vs. placebo in patients with hyperkalemic (HYP) and hypokalemic (HOP) periodic paralysis.
The trial consists of two 9-week studies-one study will enroll persons with hyperkalemic periodic paralysis and the other study will enroll persons with hypokalemic periodic paralysis. Participants will be randomly assigned to one of two treatment groups: dichlorphenamide or placebo (an inactive substance). During the studies, participants will be asked to keep a daily diary to record the time, length, and severity of each episode of weakness (attack). The study coordinator will contact participants weekly to review the diary information.
The 9-week phase will be followed by a 1-year open-label dichlorphenamide extension without placebo to determine the long-term effects of dichlorphenamide on the course of the disease and on inter-attack weakness.
Duration of the trial for participants is approximately 65 weeks, including a screening phase to determine eligibility, the first 9-week treatment phase, and the one-year open-label extension phase.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HYP Dichlorphenamide
Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.
Dichlorphenamide (double-blind)
50mg tablet; maximum dosage 400mg/day
Dichlorphenamide (open-label)
50mg tablet; maximum dosage 400mg/day
HYP Placebo
Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.
Placebo (double-blind)
Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
Dichlorphenamide (open-label)
50mg tablet; maximum dosage 400mg/day
HOP Dichlorphenamide
Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.
Dichlorphenamide (double-blind)
50mg tablet; maximum dosage 400mg/day
Dichlorphenamide (open-label)
50mg tablet; maximum dosage 400mg/day
HOP Placebo
Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.
Placebo (double-blind)
Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
Dichlorphenamide (open-label)
50mg tablet; maximum dosage 400mg/day
Interventions
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Dichlorphenamide (double-blind)
50mg tablet; maximum dosage 400mg/day
Placebo (double-blind)
Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
Dichlorphenamide (open-label)
50mg tablet; maximum dosage 400mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
1. Prolonged QT interval or complex ventricular ectopy between attacks
2. Distinctive physical features (2 of the following 5)
1. Low set ears
2. Short stature
3. Hypo-/micrognathia
4. Clinodactyly
5. Hypo-/hypertelorism
3. 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
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Rochester
OTHER
Responsible Party
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Robert Griggs, MD
Principal Investigator
Principal Investigators
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Robert C. Griggs, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Rabi Tawil, M.D.
Role: PRINCIPAL_INVESTIGATOR
Co-Principal Investigator, University of Rochester
Michael McDermott, Ph.D.
Role:
Biostatistician, University of Rochester
Locations
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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
Countries
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Other Identifiers
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CRC
Identifier Type: OTHER
Identifier Source: secondary_id
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