Dextromethorphan in Fibromyalgia

NCT03538054 | Completed Phase 2 Results FDA Drug

• 1 other identifier: F161018005
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this protocol is to evaluate if Dextromethorphan (DXM) reduces Fibromyalgia (FM) pain. DXM is a drug found in several over-the-counter products, including cough suppressants. The drug may reduce FM pain by suppressing inflammation in the central nervous system. The investigators will be observing the effects of DXM on daily self-reported pain measures in people with FM. If DXM reduces FM pain, it will provide important information about the nature of FM pathophysiology.

Conditions

Fibromyalgia

Keywords

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Daily Self-reported Pain Severity

  Daily self-reported widespread pain severity, rated on a 0 - 100 scale (0 = no pain and 100 = worst pain possible). Participants' daily scores from the last 4 weeks of each condition (placebo and dextromethorphan) were summed and then averaged across the 4-week time period.

  Daily over 4 weeks

Secondary Outcomes (2)

• Daily Self-reported Physical Activity

  Daily over 4 weeks

• Patient Global Impression of Change

  20 weeks

Study Arms (2)

Dextromethorphan

EXPERIMENTAL

Participant will take one dextromethorphan 10mg capsule in the morning and at night.

Drug: Dextromethorphan

Placebo

PLACEBO COMPARATOR

Participants will take one placebo capsule in the morning and at night.

Drug: Placebo

Interventions

Dextromethorphan DRUG

(1)10 mg, by mouth, twice daily every 12 hours.

Dextromethorphan

Placebo DRUG

1 capsule, by mouth, twice daily every 12 hours.

Placebo

Eligibility Criteria

• Age: 23 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe chronic fatigue ≥6 consecutive months not due to ongoing exertion or other medical condition associated with fatigue;
• Daily self-reported pain of at least 4 out of 10;
• \. Meets American College of Rheumatology 2016 case definition criteria for FM;
• \. Able to attend UAB for all scheduled appointments;
• \. Can complete daily self-reports of pain and other symptoms for duration of project.

You may not qualify if:

• Blood draw contraindicated or otherwise not able to be performed;
• High-sensitivity C-reactive protein (HS-CRP) ≥ 10 mg/L;
• Erythrocyte sedimentation rate (ESR) \>60 mm/hr;
• Positive rheumatoid factor;
• Positive anti-nuclear antibody (ANA);
• Abnormal thyroid stimulating hormone or free thyroxine;
• Diagnosed rheumatologic or auto-immune condition;
• Blood or clotting disorder;
• Use of blood thinning medication;
• Current use of MAOI
• Daily consumption of grapefruit juice
• Oral temperature \>100˚F at baseline;
• Febrile illness or use of antibiotics in the 4 weeks before study commencement;
• Planned surgery or procedures during the study period, or operated on in the 4 weeks before study commencement;
• Pregnant or planning on becoming pregnant within 6 months, or currently breastfeeding

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama of Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Medication was tested in a small number of fibromyalgia (FM) patients, limiting generalizability. Length of DXM treatment was only 10 weeks, so it is unclear if the results are durable. We used a single-blind design that could have led to experimenter bias. We relied only on self-reported pain rather than using objective pain assessments.

Results Point of Contact

• Title: Dr. Jarred Younger
• Organization: The University of Alabama at Birmingham

younger@uab.edu

2059755821

Study Officials

• Jarred W Younger, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will not know when they are taking placebo or the study medication.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor; Director of the Neuroinflammation, Pain and Fatigue Laboratory

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: May 25, 2018
• Study Start: June 26, 2018
• Primary Completion: March 18, 2020
• Study Completion: March 18, 2020
• Last Updated: August 26, 2022
• Results First Posted: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)