Efficacy of Dolasetron in Patients With Fibromyalgia

Study Overview
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Brief Summary
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This study offers a new treatment, dolasetron or ANZEMET ®, which will be administered by intravenous way once a day during a 4 days Hospitalization. This study is double blind (neither you nor the physician will know if you are receiving active study drug or placebo). Randomisation at the beginning of the study will decide whether you receive active treatment or its placebo. This treatment will be renewed after one month, after 2 months and after 3 months. If the study staff determines that you are eligible and you decide to participate, there will be approximately 6 study visits in about 9 months. During these visits, you will undergo routine health exams and complete different kinds of questionnaires. Following this first period of 3 months, you agree to come back for consultation at month 4, month 6 and month 12 for monitoring and evaluating the effects of treatment.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy of DOLASETRON in Patients With Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Dolasetron
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 75 Primitive Fibromyalgia according to ACR criteria Patient no responding to conventional treatment Women of childbearing age using an efficace contraception Signed consent Exclusion Criteria: Inflammatory rheumatic diseases Diseases of the system: Gougerot Sjögren, polymyositis, vasculitis, Infectious diseases: hepatitis B and C, lyme disease, HIV, Hypothyroidism, Bone and mineral metabolism disorders Disorders of cardiac conduction Failure of Heart, of kidney or liver, Patient allergic to dolasetron Pregnant or nursing women Women without means of contraception, Age <18 or > 75 years.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dolasetron<br>Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3 | Drug: Dolasetron<br>* Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3<br>|
| Placebo Comparator: Placebo<br>Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3 | Drug: Placebo<br>* Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Improving visual analogue scale (VAS) between Inclusion visit and month 3 |  | Inclusion visit and month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improving visual analogue scale (VAS) |  | Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12. | 
| Fibromyalgia impact questionnaire SF-36 scale and Beck depression scale |  | Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12. | 
| Anxiety index |  | Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12. | 
| Number of painful trigger points |  | Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12. |