Fibromyalgia
Conditions
Keywords
Fibromyalgia
Brief summary
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.
Interventions
DRUGEsreboxetine
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
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Computer based psychometric tests | 11 week |
Secondary
| Measure | Time frame |
|---|---|
| A questionnaire to assess the subjects mood | 11 weeks |
| A question to assess the subjects pain at visits | 11 weeks |
| A daily diary to assess the subjects pain | 11 weeks |
| A questionnaire to evaluate the subjects cognitive status | Once at randomisatoin |
| Two questionnaires to assess change in the subjects cognitive ability | 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 | 12 weeks |
| A questionnaire to evaluate the impact the subject perceives fibromyalgia has on their cognitive ability | Once at randomisation |
Countries
United States
Outcome results
None listed