Milnacipran for Treatment of Pain in Older Adults With Rheumatoid Arthritis

NCT01225991 | Completed Phase 4 Results DMC

• 1 other identifier: SAV-MD-10
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effects of milnacipran for the treatment of pain in rheumatoid arthritis in older adults.

Conditions

Rheumatoid Arthritis

Keywords

Pain, Fatigue, Geriatric, Rheumatoid Arthritis, Milnacipran

Outcome Measures

Primary Outcomes (1)

• Pain Rating Index

  The Pain Rating Index ranked values associated with adjectives depicting the severity of pain from the McGill Pain Questionnaire (MPQ). The assessment is comprised of 15 adjectives, each of which is scored on a scale ranging from 0 (none) to 3 (severe) and summed to arrive at a score ranging from 0 (no pain) to 45 (worst possible pain), to measure the extent of pain/tenderness and swelling. The Pain Rating Index final scores were averaged to indicate an overall report of joint pain and stiffness.

  Change score at baseline and 12 weeks

Secondary Outcomes (4)

• Visual Analogue Scale to Evaluate Fatigue (VAS-F)

  Change scores from Week 1 to Week 12 of energy and fatigue

• (UKU) Side Effects Rating Scale Profile

  Weeks 1-4, 6, 8, 10, 12

• Profile of Mood States (POMS)

  Week 1 and 12

• Connor-Davidson Resilience Scale (CD-RISC)

  Change Scores from Week 1 to Week 12

Study Arms (1)

Milnacipran, active drug, open-label

EXPERIMENTAL

All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Patients will be allowed to escalate up to 100 mg a day, or to their maximum tolerated dose in the course of the first week. The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.

Drug: Milnacipran

Interventions

Milnacipran DRUG

All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Patients will be allowed to escalate up to 100 mg a day: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day).

Also known as: Savella

Milnacipran, active drug, open-label

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Forest Laboratories: collaborator

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095, United States

Location

Related Links

• Milnacipran for Treatment of Pain in Older Adults With Rheumatoid Arthritis

MeSH Terms

Conditions

Arthritis, Rheumatoid; Pain; Fatigue

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune 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: Dr. Helen Lavretsky,
• Organization: University of California, Los Angeles

hlavretsky@mednet.ucla.edu

310-794-4619

Study Officials

• Helen Lavretsky, M.D.

  University of California, Los Angeles

  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: Professor

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 21, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 29, 2018
• Results First Posted: September 17, 2014

Record last verified: 2018-02

Locations

US (1)