A Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia.

Pfizer89 enrolled

Overview

The study is designed to assess if esreboxetine can improve the cognitive function of patients with fibromyalgia. Cognitive function is defined as the ability to concentrate, remember things and make decisions or problem solve. The study is also designed to assess if there is a difference in cognitive function between fibromyalgia patients and matched control subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fibromyalgia

Interventions

EsreboxetineDRUG

Tablet once daily either placebo, 4mg or 8mg per day. Subjects will be on active treatment for 4 weeks out of a total of 11 weeks in a crossover dosing

EsreboxetineDRUG

Tablet once daily either placebo, 4mg or 8mg per day. Subjects will be on active treatment for 4 weeks out of a total of 11 weeks in a crossover dosing

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who have a recognised diagnosis of fibromyalgia, with defined minimum pain criteria. Control subjects must not have a fibromyalgia diagnosis or symptoms and must match fibromyalgia subjects for age, length of education and gender Exclusion Criteria: * Other confounding pain, cognitive disease or impairment, disease that could put the subject at risk or subjects who are on prohibited medications that cannot be washed out. * Any subjects with a diagnosis of certain psychiatric disorders in particular major depression or suicidal risk. Matched control subjects have similar exclusions.

Locations (7)

Pfizer Investigational Site

Destin, Florida, United States

Pfizer Investigational Site

Fort Walton Beach, Florida, United States

Pfizer Investigational Site

Ann Arbor, Michigan, United States

Pfizer Investigational Site

Bingham Farms, Michigan, United States

Outcomes

Primary Outcomes

Computer based psychometric tests

Time frame: 11 week

Secondary Outcomes

A questionnaire to evaluate the subjects cognitive status

Time frame: Once at randomisatoin

A questionnaire to assess the subjects mood

Time frame: 11 weeks

A question to assess the subjects pain at visits

Time frame: 11 weeks

A daily diary to assess the subjects pain

Time frame: 11 weeks

A questionnaire to evaluate the impact the subject perceives fibromyalgia has on their cognitive ability

Time frame: Once at randomisation

Two questionnaires to assess change in the subjects cognitive ability

Time frame: 11 weeks

Safety evaluations: medical history, physical and neurological exam, heart rate and blood pressure lying and standing, laboratory tests, electrical heart trace (ECG), adverse event collection, assessment of suicidal risk

Time frame: 12 weeks

Data from ClinicalTrials.gov

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