Effect of Milnacipran on Pain in Fibromyalgia

NCT01288807 | Completed Phase 4 Results DMC

• 1 other identifier: 100686
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators want to study the effects of milnacipran treatment on neurotransmitter release in fibromyalgia.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; pain

Outcome Measures

Primary Outcomes (1)

• Concentration of Substance P in Cerebrospinal Fluid in Response to Experiemental Pain Before and After Milnacipran Treatment.

  Measure levels of Substance P present in serial samples of CSF and plasma collected over the course of 4 hours in response to application of a painful thermal stimulus at baseline ("before") and the end of 12 weeks of treatment with milnacipran 200mg daily ("after"). Substance P levels are presented. Presented data show the 10 minute and 40 minute timepoint for Substance P after pain challenge. Additional time points were not analyzed.

  12 weeks

Secondary Outcomes (4)

• Measure Sensory Threshold for Temperature Pain

  12 weeks

• Measure Sensory Thresholds for Pressure Pain

  12 weeks

• Measure Pain Ratings and Fibromyalgia Symptoms

  12 weeks

• Measure Concentrations of Serotonin and Norepinephrine Cerebrospinal Fluid and Plasma

  12 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Titrated Milnacipram doses

Drug: Milnacipram

Interventions

Milnacipram DRUG

Titration to 200mg PO daily

Also known as: Savella

Treatment

Eligibility Criteria

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

You may qualify if:

• Female age 18 or older
• Written informed consent and written release of health and research study information
• Diagnosis of Fibromyalgia
• Participant has pain greater than 4 on the NRS of 0 to 10 on average over the last week prior to initial evaluation that interferes with function most days per week
• Pain duration greater than 6 months
• Negative urine pregnancy test on experimental day 1 and 2 and on first day of treatment prior to administration of study medication and fluoroscopy
• Ability to speak and understand English, to follow instructions, and fill out study questionnaires
• Likely to complete all required visits
• Must be ambulatory and able to lay prone for 30 minutes

You may not qualify if:

• Any condition or situation that in the investigator's opinion may put the participant at significant risk, confound the study results, or interfere significantly with the participant's participation in the study
• Serious, unstable medical illness that could lead to hospitalization over the next three months; and/or a DSM-IV diagnosis(es) with active problems within the last six months, such as: schizophrenia, bipolar disorder, antisocial personality disorder, or substance use disorder
• Known, uncontrolled, serious systemic disease, including: hypertension and/or tachyarrythmia
• Females who are pregnant, breast feeding, or who plan to become pregnant, or who may potentially become pregnant
• Allergy or sensitivity to any component of the study medication or to contrast dye
• Patients on coumadin, heparin, or any other known increase risk of bleeding
• Signs of increased intracranial pressure
• Patients who are unable to continue current pain medication
• Allergy or contraindication to acetaminophen
• Use of monoamine oxidase inhibitors
• Uncontrolled narrow-angle glaucoma

Sponsors & Collaborators

• University of California, San Diego: lead
• Forest Laboratories: collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (1)

UCSD Medical Center, La Jolla

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Tobias Moeller-Bertram (PI)
• Organization: UCSD

moellerbertram@yahoo.com

7603211315

Study Officials

• Tobias Moeller-Bertram, MD, PhD, MAS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, MAS Associate Clinical Professor

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 2, 2011
• Study Start: February 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 24, 2019
• Results First Posted: September 24, 2019

Record last verified: 2019-09

Locations

US (1)