NCT01108731

Brief Summary

Use of the drug Milnacipran will reduce ventricular lactate levels and processing time for completing complex tasks relative to placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2010

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 22, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
10 months until next milestone

Results Posted

Study results publicly available

October 15, 2014

Completed
Last Updated

June 30, 2016

Status Verified

October 1, 2014

Enrollment Period

3.8 years

First QC Date

March 30, 2010

Results QC Date

July 7, 2014

Last Update Submit

May 31, 2016

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Change in Ventricular Lactate Levels in the Brain

    Ventricular lactate levels will be assessed before and at the end of the trial using a scanning method known as magnetic resonance spectroscopy (MRS), which is used to determine the presence and quantity of a number of chemicals in the brain.

    Baseline and 2 months

Secondary Outcomes (2)

  • Change in Cognitive Function Assessed by the no Cue Condition of the Attention Network Test (ANT).

    Baseline and 2 months

  • Change in Widespread Pain

    2 months

Study Arms (2)

Patients taking the drug Milnacipran

ACTIVE COMPARATOR

Randomize patients signing informed consent and give 50% of them Milnacipran -- blinded to the investigators.

Drug: Milnacipran

Patients taking the placebo

PLACEBO COMPARATOR

Randomize patients signing informed consent and give 50% of them the placebo -- blinded to the investigators.

Drug: Placebo

Interventions

MilnacipranDRUG

Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.

Also known as: Savella
Patients taking the drug Milnacipran
PlaceboDRUG

Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.

Patients taking the placebo

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female or male subjects who fulfill the American College of Rheumatology's case definition for Fibromyalgia.
  • through 68 years of age

You may not qualify if:

  • Pregnant or trying to become pregnant
  • Taking any other Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or already taking milnacipran
  • Patients who do not indicate their pain levels as less than substantial despite their best care
  • History of any psychotic disorder or history of alcoholism or drug abuse within 10 years of intake as determined by psychiatric diagnostic interview
  • Presence of current depression as determined by psychiatric diagnostic interview
  • Presence of brain lesion on MRI anatomical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain and Fatigue Study Center - Beth Israel Medical Center

New York, New York, 10003, United States

Location

Related Publications (1)

  • Natelson BH, Vu D, Mao X, Weiduschat N, Togo F, Lange G, Blate M, Kang G, Coplan JD, Shungu DC. Effect of Milnacipran Treatment on Ventricular Lactate in Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pain. 2015 Nov;16(11):1211-9. doi: 10.1016/j.jpain.2015.08.004. Epub 2015 Aug 31.

    PMID: 26335989DERIVED

Related Links

MeSH Terms

Conditions

Fibromyalgia

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

CyclopropanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr Benjamin Natelson
Organization
Beth_IsraelMC
bnatelson@chpnet.org
212-844-6747

Study Officials

  • Benjamin H Natelson, MD

    Beth Israel Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2010

First Posted

April 22, 2010

Study Start

March 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

June 30, 2016

Results First Posted

October 15, 2014

Record last verified: 2014-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)