Moxonidine for the treatment of fibromyalgia: a prospective double-blind, randomised, single-centre, placebo-controlled, parallel group study

ISRCTN	ISRCTN70535562
DOI	https://doi.org/10.1186/ISRCTN70535562
Secondary identifying numbers	BP3/2005

Submission date: 16/10/2005
Registration date: 07/11/2005
Last edited: 21/09/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ferran J Garcia-Fructuoso
Scientific

Paseo Manuel Girona, 33
Clinica CIMA
Barcelona
08034
Spain

Study information

Study design	A prospective double-blind, randomised, single-centre, placebo-controlled, parallel group study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Fibromyalgia
Intervention	1. Moxonidine 0.2 mg/12 hours 2. Placebo/12 hours
Intervention type	Other
Primary outcome measure	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 study start date	01/12/2005
Completion date	30/08/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60
Key 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
Key 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
Date of first enrolment	01/12/2005
Date of final enrolment	30/08/2006

Locations

Countries of recruitment

Spain

Study participating centre

Paseo Manuel Girona, 33

Barcelona
08034
Spain

Sponsor information

Foundation for Fibromyalgia and Chronic Fatigue Syndrome (Spain)
Charity

Joan Guell
184 Dp. 27
Barcelona
08028
Spain

Email	info@fundacionfatiga.org
Website	http://www.fundacionfatiga.org
"ROR"	https://ror.org/03p4nrj93

Funders

Funder type

Charity

Foundation for Fibromyalgia and Chronic Fatigue Syndrome (Fundacion para la Fibromialgia y el Síndrome de Fatiga Crónica) (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan