Dextromethorphan in Fibromyalgia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03538054|
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: Dextromethorphan Drug: Placebo||Phase 2|
Fibromyalgia (FM) is a chronic, widespread pain syndrome. Individuals with FM frequently report body pain, fatigue, sleep issues, cognitive impairment, headaches, and other symptoms. The disease affects approximately 5% of women in the United States. Many of those patients suffer with decreased quality of life and loss of employment.
The precise pathological mechanism of FM is not yet understood, and there is no targeted treatment for the condition. One hypothesis of FM with prior scientific support is that pain is caused by abnormal inflammation of the brain. When microglia cells in the brain adopt an inflammatory state, they release chemicals that can cause neurons to increase the transmission of pain signals.
DXM has been used in previous research and demonstrated to suppress pain symptoms. When given at higher dosages (above 200mg), the medication acts as a dissociative agent. This dosage can reduce pain, but produces side-effects that can limit daily functioning. At lower dosages, however, DXM may reduce inflammatory aspects of chronic pain while not causing dissociative side effects.
In animal models, central inflammation can be reduced with intraperitoneal dosages of DXM of 0.1mg/kg. In an average U.S. woman, this dosage would translate to approximately 8mg. Because an oral versus intraperitoneal dosing route will be used, the dose will be raised to 10mg, administered twice a day (once in the morning and once at night). The investigator will examine the impact of 20mg total daily DXM on self-reported FM pain.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking Description:||The participant will not know when they are taking placebo or the study medication.|
|Official Title:||Dextromethorphan in Fibromyalgia|
|Estimated Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||June 1, 2020|
Participant will take one dextromethorphan 10mg capsule in the morning and at night.
(1)10 mg, by mouth, twice daily every 12 hours.
Placebo Comparator: Placebo
Participants will take one placebo capsule in the morning and at night.
1 capsule, by mouth, twice daily every 12 hours.
- Daily self-reported pain severity [ Time Frame: For the primary test of efficacy, average pain over the final 4 weeks of DXM condition contrasted with final 4 weeks of placebo condition. ]The primary outcome will be daily self-reported widespread pain severity, rated on a 0 - 100 scale (100 = worst pain possible).
- Daily self-reported physical activity [ Time Frame: Test of efficacy will use average activity over the final 4 weeks of the DXM condition contrasted with final 4 weeks of placebo condition. ]Secondary outcome #1 is self-reported daily activity, rated from 0 - 100.
- Patient global impression of change [ Time Frame: Over the 20-week placebo and DXM periods, we will contrast PGIC rating provided at the end of the placebo condition with PGIC rating provided at the end of the DXM condition. ]Secondary outcome #2 is the patient global impression of change (PGIC) measured in a seven point likert scale (from no change to a great deal better).
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): NCT03538054
|Contact: Kate M Wesson Sides, BSemail@example.com|
|Contact: Tammie Quinn, BSfirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama of Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Kate M Wesson Sides, BS 205-975-5850 cfs@Uab.edu|
|Principal Investigator:||Jarred W Younger, PhD||University of Alabama at Birmingham|