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Sponsors and Collaborators: |
University of Rochester National Institute of Neurological Disorders and Stroke (NINDS) |
Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00494507 |
The purpose of this study is to determine which drug, acetazolamide or dichlorphenamide is better for treating periodic paralysis and for improving strength.
Condition | Intervention | Phase |
Paralysis, Periodic |
Drug: acetazolamide Drug: dichlorphenamide Drug: placebo |
Phase III |
Genetics Home Reference related topics: | hypokalemic periodic paralysis |
MedlinePlus related topics: | Paralysis |
Drug Information available for: | Dichlorphenamide Acetazolamide Acetazolamide sodium |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Dichlorphenamide vs. Acetazolamide for Periodic Paralysis |
Estimated Enrollment: | 252 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
acetazolamide
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Drug: acetazolamide
has been prescribed to treat periodic paralysis
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2: Active Comparator
dichlorphenamide
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Drug: dichlorphenamide
has been prescribed to treat periodic paralysis, but is no longer available
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3: Placebo Comparator |
Drug: placebo
an inactive substance
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Periodic paralysis is a relatively rare, life-long disorder characterized by intermittent bouts of paralysis, progressive weakness, and diminished quality of life. Two drugs—acetazolamide and dichlorphenamide—have been prescribed to treat the disorder, however, dichlorphenamide is no longer available. And, it is not known which drug better prevents episodes of paralysis or the chronic, progressive weakness that occurs between episodes. Also, unknown is which drug is preferable for preventing episodes and treating weakness.
In this multi-center, parallel, randomized trial researchers will compare acetazolamide and dichlorphenamide to determine which is better for preventing episodes of paralysis, treating weakness, and improving strength.
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 three treatment groups: acetazolamide, dichlorphenamide, or placebo (an inactive substance). During the studies, participants will be asked to keep a daily computer diary to record the time, length, and severity of each episode of weakness. The study coordinator will contact participants weekly to review the diary information.
The 9-week studies will be followed by 1-year extensions to compare the long-term effects of acetazolamide and dichlorphenamide on the course of periodic paralysis. Participants who initially received a placebo during the 9-week studies will be randomly assigned to receive either acetazolamide or dichlorphenamide during the extension studies.
Duration of the trial for participants is a maximum of 61 weeks, including the first 9-week treatment phase and the one-year extension phase.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Evidence for Andersen-Tawil syndrome (any one of the following 3 criteria)
Distinctive physical features (2 out of 5)
Contact: Patty Smith | 585-275-4339 |
United States, California | |||||
University of California-San Francisco | Recruiting | ||||
San Francisco, California, United States, 94143 | |||||
Contact: Kristin Wong 415-502-3976 | |||||
Principal Investigator: Jeffrey Ralph, MD | |||||
United States, Kansas | |||||
University of Kansas Medical Center | Recruiting | ||||
Kansas City, Kansas, United States, 66160 | |||||
Contact: Maureen Walsh 913-588-5095 | |||||
Principal Investigator: Richard Barohn, MD | |||||
United States, Massachusetts | |||||
Brigham & Women's Hospital | Recruiting | ||||
Boston, Massachusetts, United States, 02115 | |||||
Contact: Kristen Whiteside 617-525-6763 | |||||
Principal Investigator: Anthony Amato, MD | |||||
United States, Minnesota | |||||
Mayo Clinic | Recruiting | ||||
Rochester, Minnesota, United States, 55905 | |||||
Contact: Janet Fisher 507-538-2433 | |||||
Principal Investigator: Brian Crum, MD | |||||
United States, New York | |||||
University of Rochester | Recruiting | ||||
Rochester, New York, United States, 14642 | |||||
Contact: Patty Smith 585-275-4339 | |||||
Principal Investigator: Emma Ciafaloni, MD | |||||
Columbia University Medical Center | Recruiting | ||||
New York, New York, United States, 10032 | |||||
Contact: Kate Bednarz 212-305-2027 | |||||
Principal Investigator: Petra Kaufmann, MD | |||||
United States, Ohio | |||||
Ohio State University | Recruiting | ||||
Columbus, Ohio, United States, 43210 | |||||
Contact: Amy Bartlett 614-366-9050 | |||||
Principal Investigator: John Kissel, MD | |||||
United States, Texas | |||||
University of Texas Southwestern-Dallas | Recruiting | ||||
Dallas, Texas, United States, 75390 | |||||
Contact: Nina Gorham 214-648-0462 | |||||
Principal Investigator: Stephen C. Cannon, MD | |||||
Canada, Ontario | |||||
London Health Sciences Center | Not yet recruiting | ||||
London, Ontario, Canada, N6A 5A5 | |||||
Contact: Wilma Koopman 519 663-3041 | |||||
Principal Investigator: Angelika Hahn, MD | |||||
France | |||||
Hospital Pitie-Salpetriere, Salpetriere | Not yet recruiting | ||||
Paris, France | |||||
Contact: Savine Vicart 33 140 778119 | |||||
Principal Investigator: Bertrand Fontaine, MD | |||||
Italy, Milan | |||||
University of Milan | Not yet recruiting | ||||
San Donato, Milan, Italy | |||||
Contact: Valeria Sansone 39 02 5607450 | |||||
Principal Investigator: Giovanni Meola, MD | |||||
United Kingdom | |||||
Institute of Neurology-Queen's Square | Not yet recruiting | ||||
London, United Kingdom | |||||
Contact: Susan Tomlinson 011 44 207 837 3611 ext 4251 | |||||
Principal Investigator: Michael Hanna, MD |
University of Rochester |
National Institute of Neurological Disorders and Stroke (NINDS) |
Principal Investigator: | Robert C. Griggs, M.D. | |
Investigator: | Rabi Tawil, M.D. | Co-Principal Investigator |
Investigator: | Michael McDermott, Ph.D. | Biostatistician |
Responsible Party: | University of Rochester ( Robert C. Griggs, MD ) |
Study ID Numbers: | R01NS045686-02 |
First Received: | June 27, 2007 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00494507 |
Health Authority: | United States: Food and Drug Administration |
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