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| Sponsor: | University of Rochester |
|---|---|
| Collaborator: |
National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by (Responsible Party): | Robert Griggs, MD, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00494507 |
Purpose
The purpose of this study is to compare Dichlorphenamide with placebo (an inactive substance) for prevention of episodes and for improvement of strength in periodic paralysis. This study will also look at the long-term effects of Dichlorphenamide in periodic paralysis.
| Condition | Intervention | Phase |
|---|---|---|
|
Periodic Paralysis |
Drug: Dichlorphenamide Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Dichlorphenamide vs. Placebo for Periodic Paralysis |
| Estimated Enrollment: | 140 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Dichlorphenamide |
Drug: Dichlorphenamide
has been prescribed to treat periodic paralysis, but is no longer available
|
|
Placebo Comparator: Placebo
inactive substance
|
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.
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. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Distinctive physical features (2 out of 5)
Contacts and Locations| Contact: Patty Smith | 585-275-4339 |
| United States, California | |
| UCLA Neurology | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Russell Byrns 310-825-3264 | |
| Principal Investigator: Perry Shieh, MD | |
| University of California-San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Dennis Robins 415-353-3667 | |
| 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 Roe 617-525-6763 | |
| Principal Investigator: Anthony Amato, MD | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Delana Weis 507-266-7196 | |
| Principal Investigator: Brian Crum, MD | |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St Louis, Missouri, United States, 63110 | |
| Contact: Pamela Townsend 314-747-8288 | |
| Principal Investigator: Alan Pestronk, MD | |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Nicole Armstrong 212-305-8148 | |
| Principal Investigator: Hiroshi Mitsumoto, MD | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Laura Zak 585-276-5432 | |
| Principal Investigator: Emma Ciafaloni, 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 | |
| Sub-Investigator: Jaya Trivedi, MD | |
| France | |
| Hospital Pitie-Salpetriere | Not yet recruiting |
| Paris, France | |
| Contact: Savine Vicart, MD 33 1 42161691 | |
| Principal Investigator: Bertrand Fontaine, MD | |
| Sub-Investigator: Savine Vicart, MD | |
| Italy | |
| University of Milan | Recruiting |
| San Donato, Milan, Italy | |
| Contact: Valeria Sansone 39 02 5607450 | |
| Principal Investigator: Giovanni Meola, MD | |
| Sub-Investigator: Valeria Sansone, MD | |
| United Kingdom | |
| Institute of Neurology-Queen's Square | Recruiting |
| London, United Kingdom | |
| Contact: James Burge, MD +44 (0) 207 837 3611 ext 4320 | |
| Principal Investigator: Michael Hanna, MD | |
| Principal Investigator: | Robert C. Griggs, M.D. | University of Rochester |
| Principal Investigator: | Rabi Tawil, M.D. | Co-Principal Investigator, University of Rochester |
| Investigator: | Michael McDermott, Ph.D. | Biostatistician, University of Rochester |
More Information
| Responsible Party: | Robert Griggs, MD, Principal Investigator, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00494507 History of Changes |
| Other Study ID Numbers: | R01NS045686-02, CRC |
| Study First Received: | June 27, 2007 |
| Last Updated: | January 24, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
periodic paralysis dichlorphenamide |
|
Paralyses, Familial Periodic Hypokalemic Periodic Paralysis Paralysis Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Metal Metabolism, Inborn Errors Metabolism, Inborn Errors |
Genetic Diseases, Inborn Metabolic Diseases Neurologic Manifestations Signs and Symptoms Dichlorphenamide Carbonic Anhydrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
