Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BP3/2005
Study information
Scientific title
Acronym
Study hypothesis
Fibromyalgia (FM) is a common illness that affects ~ 2.5% of the general population, of which the majority (9/1) are female. FM is characterized by chronic widespread pain and by sleeping problems. Patients with FM frequently have other symptoms such as headaches, nocturnal jaw tightness, morning stiffness, tingling and numbness of arms and legs, irritable bowel, urinary urgency, dryness in the mouth and eyes, cold swollen hands, anxiety and/or depression. Another characteristic of FM is tenderness at palpation in defined points at the neck and lower back areas.
Hypothesis:
Sympathetic nervous system function in fibromyalgia seems overactivated. I1-Imidazoline agonist Moxonidine decreases sympathetic nerve activity. This study assess the efficacy and safety of Moxonidine in patients with fibromyalgia.
Ethics approval
Not provided at time of registration
Study design
A prospective double-blind, randomised, single-centre, placebo-controlled, parallel group study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Fibromyalgia
Intervention
1. Moxonidine 0.2 mg/12 hours
2. Placebo/12 hours
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary outcome was improvement in the pain score (10-cm visual analog scale [VAS]) at 24 weeks.
Secondary outcome measures
1. Fibromyalgia Impact Questionnaire (FIQ)
2. The tender point score
3. The Hamilton Anxiety and Depression Scale (HADS)
Overall trial start date
01/12/2005
Overall trial end date
30/08/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Ages eligible for study: 30 - 60 years
2. Genders eligible for study: both
3. Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) criteria
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Psychiatric illness
2. Depression
3. Suicidal risk
4. Substance abuse
5. Pulmonary dysfunction
6. Renal impairment
7. Active cardiac disease
8. Liver disease
9. Autoimmune disease
10. Cancer
11. Sleep apnea
12. Chronic Fatigue Syndrome
13. Inflammatory bowel disease
14. Contraindication of Moxonidine
Recruitment start date
01/12/2005
Recruitment end date
30/08/2006
Locations
Countries of recruitment
Spain
Trial participating centre
Paseo Manuel Girona, 33
Barcelona
08034
Spain
Sponsor information
Organisation
Foundation for Fibromyalgia and Chronic Fatigue Syndrome (Spain)
Sponsor details
Joan Guell
184 Dp. 27
Barcelona
08028
Spain
info@fundacionfatiga.org
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Foundation for Fibromyalgia and Chronic Fatigue Syndrome (Fundacion para la Fibromialgia y el Síndrome de Fatiga Crónica) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary