Fibromyalgia Clinical Trial
Official title:
Combining N-of-1 Trials to Assess Fibromyalgia Therapies
This study will compare the effectiveness of combination therapy with the drugs amitriptyline and fluoxetine (AM+FL) and amitriptyline (AM) alone in the treatment of people with fibromyalgia. Doctors will treat each study participant with both AM + FL and AM alone for 6 weeks at a time. The study uses a method that combines results from treatment of individual patients to assess overall treatment effectiveness and help individual patients and their physicians with their treatment decisions. This study will also help compare the results of community-based studies (studies involving private doctors) and studies based at clinical research centers.
This study will use the combined N-of-1 method to compare the effectiveness of the
combination therapy amitriptyline and fluoxetine (AM+FL) versus amitriptyline (AM) alone in
patients with fibromyalgia (FM). It will also compare community-based and center-based trial
results. We will ask community-based, board-certified rheumatologists to participate as
investigators and we will also carry out a center-based study (at Newton-Wellesley
Hospital). Physicians will ask patients meeting eligibility criteria to participate in this
study and undergo an N-of-1 trial.
Each N-of-1 trial will consist of three paired crossover periods (each 6-weeks long) during
which the patient will receive either AM + placebo (placebo every morning and AM 25 mg at
night) or combination treatment AM+FL (FL 20 mg in the morning and AM 25 mg at night). The
dispensing pharmacy will carry out paired randomization.
We will assess patient evaluations and outcome measures at baseline prior to trial, at the
end of each treatment period, and 3 months after completion of the N-of-1 trial. In
addition, at baseline, we will obtain demographic information, an electrocardiogram, and
baseline blood tests. We may ask patients to have additional blood tests at the period
evaluations. We will also do a pregnancy test for all women of child-bearing age enrolling
in the study. The main study outcome measure will be the Fibromyalgia Impact Questionnaire
(FIQ). Additional measures will include the Visual Analog Scales (VAS) for pain, sleep,
global well-being; Physician VAS for global well-being; and tender-point score.
We will analyze the results of the N-of-1 trials in two ways: (1) using only the individual
patient's results (classic one-sided t-test) and (2) using the patient's results in
combination with the results of other patients who underwent similar trials (the combined
N-of-1 approach). To obtain the latter information, we will include each patient's results
for the collective analysis. We will provide these results back to the physicians and will
record the final treatment decisions the physicians reach with their patients. In addition,
we will ask both physicians and patients to comment on their participation in an N-of-1
trial and this research process. Followup of patients 3 months after completion of their
N-of-1 trial will include determining current medication and a current outcome assessment.
Investigators will record all adverse drug reactions and patients withdrawn from studies.
They will also record the reason for withdrawal for all patients choosing to withdraw. We
will include results from patients who drop out due to reasons other than drug reactions in
the combined N-of-1 analyses if completed period pair results are available. An independent
safety officer will review all withdrawals.
Results of individual patient trials will be confidential; however, we will combine these
results (after removal of patient identifiers) with the results of other patients, and will
publish the overall results of this study. We will maintain the connection of results to
patient identifiers only to enable us to provide results to individual investigators and
their patients.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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