Evaluation of the Efficiacy of Mecobalamine in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia

Linnaeus University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Fibromyalgia

Treatments: Other: Placebo Comparator : NaCl 9 mg/ml; Drug: Mecobalamin 5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05008042

EUDRACT 2015-005086-23

Details and patient eligibility

About

Fibromyalgia causes long term pain where mostly women are affected. It is not entirely clear how vitamin B12 affects the human pain system, there are however many primary studies that indicate different interesting approaches. Considering that the receptor of NMDA is involved in both long-term pain and vitamin B12 deficiency its of most importance to evaluate whether vitamin B12 decreases the pain sensitivity and the experience of pain i.e hyperalgesia and allodynia, at persons with fibromyalgia.The aim of this study is therefore to evaluate the effect of Mecobalamin (vitamin B12), and describe lived experiences of pain, health, suffering and well-being in women with diagnosed fibromyalgia.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 20-70 years
• Swedish-speaking
• Diagnosis of fibromyalgia
• Safe method of contraception
• Cobalamin / p (vitamin B12) should be >250 pmol/L < 800 pmol/L
• Given consent to participate.

Exclusion criteria

• Previous treatment with B12
• Known hypersensitivity to the active substance Mecobalamin or an additive
• Vegan as veganism can lead to B12 deficiency
• Neuroleptics
• Known heart, kidney or liver disease
• Reynaud's phenomenon (white fingers)
• Known neuropathy (impaired sensation)
• Breastfeeding
• Pregnancy or plan pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Mecobalamine 5 mg/ml

Active Comparator group

Description:

The active substance of vitamin B12 given in the study is Mecobalamin 5mg / ml 2 ml ie 10 mg and is given intramuscularly.

Treatment:

Drug: Mecobalamin 5 MG

NaCl 9mg/ml

Placebo Comparator group

Description:

Placebo substance given in the study is Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) given intramuscularly.

Treatment:

Other: Placebo Comparator : NaCl 9 mg/ml