Lithium in Inclusion Body Myositis (IBM) (Li-IBM)
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Purpose
| Condition |
|---|
| Inclusion Body Myositis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Pilot Trial of Lithium in Inclusion Body Myositis (IBM) |
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Trial Status Open for Enrollment
What is the Purpose of this Study? There is currently no effective treatment for IBM and its pathogenesis remains uncertain. This study is designed to test the hypothesis that treatment of patients with IBM with Lithium can improve muscle strength and reduce the markers of disease activity believed to be important in the disease pathogenesis.
Who is Eligible to Participate? Patients diagnosed with Inclusion Body Myositis above the age of 30 who have adequate muscle function for quantitative muscle testing and who have a FVC >50%. Patients who have uncontrolled diabetes, renal insufficiency, congestive heart failure, cancer, hypothyroidism, current use of immunosuppressive medication, currently on warfarin or any known bleeding disorder are excluded.
What is involved in this Study? This is an open label trial looking at the effects of Li on muscle strength. Procedures consist of a baseline muscle biopsy, blood work, and other screening procedures. After the muscle biopsy patients are started on Li at 300mg/d. Lithium doses are dependent on tolerability and target lithium levels. Monthly visits consist of EKGs, Li level labs, questionnaires, and muscle strength testing. At month 6, patients will receive another muscle biopsy. The muscle biopsies are performed to analyze p-tau levels in the muscle.
How long is the Study? It is approximately 6 months long; however patients have the option to stay on the study for an additional 6 months.
Eligibility
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 30 Years to 88 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Age >30
- Meet diagnostic criteria for definite IBM
- Muscle function adequate for quantitative muscle testing
- Able to give informed consent
- Women of child bearing potential must have a negative pregnancy test
Exclusion Criteria:
- Presence of uncontrolled diabetes, hypothyroidism, chronic infection, chronic renal insufficiency, congestive heart failure, cancer, or other chronic serious medical conditions
- Significant arrhythmias or conduction defect abnormalities on ECG
- Pregnant or lactating
- Coexistence of other neuromuscular or neurological diseases that would interfere with assessment
- Known bleeding disorder
- On Warfarin
- Contraindications to muscle biopsy: allergy to local anesthetic, skin infection, known bleeding disorder
Contacts and Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917956
| United States, Arizona | |
| Phoenix Neurological Associates, LTD | |
| Phoenix, Arizona, United States, 85018 | |
| Principal Investigator: | David D Saperstein, MD | Phoenix Neurological Associates, LTD |
More Information
| Responsible Party: | David Saperstein, MD, Phoenix Neurological Associates, LTD |
| ClinicalTrials.gov Identifier: | NCT00917956 History of Changes |
| Other Study ID Numbers: |
WIRB #: 20071696 Study Number 1093885 |
| First Submitted: | June 8, 2009 |
| First Posted: | June 11, 2009 |
| Last Update Posted: | February 26, 2010 |
| Last Verified: | February 2010 |
Keywords provided by Phoenix Neurological Associates, LTD:
|
Lithium IBM InclusionIBM Myositis |
Additional relevant MeSH terms:
|
Myositis Myositis, Inclusion Body Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Lithium Carbonate Antidepressive Agents |
Psychotropic Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |