Neurotropin Treatment of Fibromyalgia

Summary

This study will examine the safety and effectiveness of the experimental drug, neurotropin, for preventing or easing pain associated with fibromyalgia. A disorder that primarily affects women, fibromyalgia causes widespread aching and stiffness in muscles. Neurotropin has been used in Japan for many years to treat various chronic painful conditions, including fibromyalgia.

Women with fibromyalgia who have been treated unsuccessfully with standard therapy may be eligible for this study. Patients must have a history of widespread pain for more than half of the days in each of the three months before they enter the study. Candidates are screened with a medical history, physical examination, blood and urine tests, questionnaires and an electrocardiogram (EKG).

Participants take their usual medications for fibromyalgia in addition to either neurotropin or a placebo (look-alike medicine with no active ingredient). At 6 weeks and 12 weeks into the study, they return to the NIH Clinical Center for evaluation of their sensitivity to pain and level of physical capability. After 12 weeks, study subjects "cross-over" their medication; that is, patients who took neurotropin for the first 12 weeks of the study take placebo for the next 12 weeks, and vice-versa. Again, after 6 and 12 weeks, patients return for evaluation.

Participants have blood and urine tests six times during the study and complete questionnaires each week about their pain, symptoms, and activities.

Conditions

• Fibromyalgia

Interventions

DRUG

Placebo

4 tabs b.i.d.

DRUG

Neurotropin

4 tabs b.i.d.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• National Institutes of Health Clinical Center (CC)

  collaborator NIH

• University of Michigan

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• National Institute of Nursing Research (NINR)

  lead NIH

Principal Investigators

• Leorey N Saligan, C.R.N.P. · National Institute of Nursing Research (NINR)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-08-31

Primary Completion

2015-12-31

Completion

2015-12-31

FDA Drug

Yes

Countries

• United States

Study Locations