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| Sponsor: | University of Rochester |
|---|---|
| Collaborator: |
National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by: | University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00494507 |
Purpose
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 |
|---|---|---|
|
Periodic Paralysis |
Drug: acetazolamide Drug: dichlorphenamide Drug: placebo |
Phase III |
| 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
|
Drug: acetazolamide
has been prescribed to treat periodic paralysis
|
|
2: Active Comparator
dichlorphenamide
|
Drug: dichlorphenamide
has been prescribed to treat periodic paralysis, but is no longer available
|
| 3: Placebo Comparator |
Drug: placebo
an inactive substance
|
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.
Eligibility| 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)
Contacts and Locations| Contact: Patty Smith | 585-275-4339 |
| United States, California | |
| University of California-San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Claudia Villierme 415-476-2662 | |
| Principal Investigator: Jeffrey Ralph, MD | |
| United States, Kansas | |
| University of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Victoria Watts 913-588-5479 | |
| 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 Dalton 212-305-2027 | |
| Principal Investigator: Jinsy Andrews, 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: Jennifer Verheyden 519-685-8500 ext 34858 | |
| 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: Gisela Barreto 011 44 207 837 3611 ext 3888 | |
| Principal Investigator: Michael Hanna, MD | |
| Principal Investigator: | Robert C. Griggs, M.D. | University of Rochester |
| Investigator: | Rabi Tawil, M.D. | Co-Principal Investigator |
| Investigator: | Michael McDermott, Ph.D. | Biostatistician |
More Information
| Responsible Party: | University of Rochester ( Robert C. Griggs, MD ) |
| Study ID Numbers: | R01NS045686-02 |
| Study First Received: | June 27, 2007 |
| Last Updated: | October 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00494507 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
periodic paralysis acetazolamide dichlorphenamide |
|
Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Hypokalemic Periodic Paralysis Acetazolamide Signs and Symptoms Metabolism, Inborn Errors Neuromuscular Diseases Musculoskeletal Diseases Therapeutic Uses Metabolic Diseases Dichlorphenamide Nervous System Diseases |
Enzyme Inhibitors Cardiovascular Agents Metal Metabolism, Inborn Errors Pharmacologic Actions Paralysis Carbonic Anhydrase Inhibitors Muscular Diseases Paralyses, Familial Periodic Genetic Diseases, Inborn Natriuretic Agents Neurologic Manifestations Central Nervous System Agents Anticonvulsants |
