NCT01221740

Brief Summary

  1. 1.To show that patients with greater pain sensitivity will show greater improvement in their symptoms (self-reported pain intensity, mood, sleep, and quality of life) than those with lower pain sensitivity, based on QST, after taking milnacipran.
  2. 2.To compare outcome differences (pain intensity, mood, activity interference, sleep, and side effects) with those patients who are either taking or not taking opioids for their pain 10 weeks after being prescribed milnacipran.
  3. 3.To show that patients who are older, male, with more medical comorbidities, greater disability, and longer pain duration will report less improvement (pain, mood, sleep, health-related quality of life) and treatment satisfaction while taking milnacipran compared with others without such characteristics.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

October 14, 2010

Last Update Submit

January 11, 2017

Conditions

Back Pain

Keywords

To show that patients with greater pain sensitivitywill show greater improvement in their symptoms(self-reported pain intensity, mood, sleep, andquality of life) than those with lower painsensitivity, based on QST, after taking milnacipran.To compare outcome differences(pain intensity, mood, activity interference,sleep, and side effects) with those patientswho are either taking or not taking opioids fortheir pain 10 weeks after being prescribed milnacipran.To show that patients who are older, male,with more medical comorbidities, greater disability,and longer pain duration will report less improvement(pain, mood, sleep, health-related quality of life)and treatment satisfaction while taking milnaciprancompared with others without such characteristics.identify patients back or neck paingreater 6 monthsQST10 weeksmilnacipranpain intensitymoodactivityinterferencesleepside effectsagegendermedical comorbiditiespain diagnosispain durationdisability status

Outcome Measures

Primary Outcomes (1)

  • Decreased Back Pain

    Decreased Back Pain on the Brief Pain Inventory Scale.

    Over the course of 10 weeks

Study Arms (1)

Milnacipran

EXPERIMENTAL

The patients will be titrated to the maintenance dose of 50 mg BID over a 7-day period. 12.5 mg QD on day 1 12.5 mg BID on days 2 and 3 25 mg BID on days 4, 5, 6, and 7 50 mg BID beginning day 8

Drug: Savella

Interventions

SavellaDRUG

The patients will be titrated to the maintenance dose of 50 mg BID over a 7-day period, and will be on the medication for 10 weeks. 12.5 mg QD on day 1 12.5 mg BID on days 2 and 3 25 mg BID on days 4, 5, 6, and 7 50 mg BID beginning day 8

Also known as: HCL (Savella), Milnacipran
Milnacipran

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Primary diagnosis of spinal pain for at least 6 months' duration
  • Average pain intensity score of 4 or greater

You may not qualify if:

  • Current diagnosis of cancer or malignant disease
  • Acute bone disease
  • History of DSM-IV psychotic disorder
  • Pregnancy
  • Any illness judged by the PI to interfere with treatment
  • Any acute condition requiring surgery
  • Currently taking SNRI or MAOI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital Pain Trials Center

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Back PainHypersensitivityPainNeck PainMotor ActivityCoitus

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsImmune System DiseasesBehaviorSexual Behavior

Intervention Hierarchy (Ancestors)

CyclopropanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Robert Jamison, PhD

Study Record Dates

First Submitted

October 14, 2010

First Posted

October 15, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

US(1)