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| Sponsor: | Michael Benatar |
|---|---|
| Collaborator: |
Food and Drug Administration (FDA) |
| Information provided by (Responsible Party): | Michael Benatar, University of Miami |
| ClinicalTrials.gov Identifier: | NCT00995722 |
Purpose
The purpose of this study is to evaluate the efficacy and tolerability of prednisone in patients diagnosed with ocular myasthenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Ocular Myasthenia Gravis |
Drug: Prednisone Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy of Prednisone In the Treatment of Ocular Myasthenia: The EPITOME' Study |
| Estimated Enrollment: | 88 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Prednisone
Corticosteroid
|
Drug: Prednisone
Prednisone and placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone or matching placebo.
Other Name: Steroid
|
|
Placebo Comparator: Placebo
Matched, inactive substance
|
Drug: Placebo
Prednisone and placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone or matching placebo.
Other Name: Sugar pill
|
The purpose of this study is to learn two things about prednisone in patients with ocular myasthenia. The first thing we aim to learn is whether or not prednisone is effective in improving the symptoms of double vision and drooping eyes that are experienced by patients with ocular myasthenia. The second thing we aim to learn is whether we can find a dose of prednisone that is well tolerated and safe. The overall goal is to find out whether a dose of prednisone that is safe and well tolerated is also effective in improving the symptoms of ocular myasthenia.
After completing screening assessments to confirm eligibility, all participants will receive treatment with pyridostigmine. If a participant's symptoms do not resolve within the first month while being treated with pyridostigmine, they will be randomized to receive prednisone or placebo. The amount of study medication a participant receives will depend on how their symptoms respond to the medication and if they experience any side effects.
After four months, participants that continue to have symptoms of ocular myasthenia and do not have side effects will receive open label high dose prednisone. Participants that no longer have symptoms will taper their dose of study drug in a double-blind fashion.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michael Benatar, MBChB, DPhil | mbenatar@med.miami.edu | |
| Contact: Farheen Hussain, MS | Farheen_Hussain@URMC.Rochester.edu |
| United States, Florida | |
| Michael Benatar | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Michael Benatar, MBChB, DPhil 305-243-6480 mbenatar@med.miami.edu | |
| Contact: Alexandra Waltz, MA 305-243-3799 awaltz@med.miami.edu | |
| Principal Investigator: Michael Benatar, MBChB, DPhil | |
| United States, Kansas | |
| University of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Richard Barohn, MD 913-588-6094 rbarohn@kumc.edu | |
| Contact: Laura Herbelin 913-588-5095 lherbelin@kumc.edu | |
| Principal Investigator: Richard Barohn, MD | |
| United States, North Carolina | |
| Duke University Medical Center | Not yet recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Vern Juel, MD | |
| Principal Investigator: Vern Juel, MD | |
| United States, Texas | |
| University of Texas Southwestern Medical Center | Not yet recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Srikanth Muppidi, MD | |
| Principal Investigator: Srikanth Muppidi, MD | |
| United States, Virginia | |
| University of Virginia | Not yet recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Ted Burns, MD | |
| Principal Investigator: Ted Burns, MD | |
| Principal Investigator: | Michael Benatar, MBChB, DPhil | University of Miami |
| Study Director: | Gil Wolfe, MD | University of Texas Southwestern Medical Center |
| Study Director: | Donald Sanders, MD | Duke University |
More Information
| Responsible Party: | Michael Benatar, MBChB, DPhil, University of Miami |
| ClinicalTrials.gov Identifier: | NCT00995722 History of Changes |
| Other Study ID Numbers: | FD-R-03710-01 |
| Study First Received: | October 14, 2009 |
| Last Updated: | February 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Ocular myasthenia gravis Prednisone Steroids |
|
Myasthenia Gravis Muscle Weakness Autoimmune Diseases of the Nervous System Nervous System Diseases Neuromuscular Junction Diseases Neuromuscular Diseases Autoimmune Diseases Immune System Diseases Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations |
Pathologic Processes Signs and Symptoms Prednisone Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |