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

NCT05008042 | Completed Phase 1 DMC

• 1 other identifier: EUDRACT 2015-005086-23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia,; Chronic pain,; Mekobalamin,; Randomized Controlled Trial; VitaminB12

Outcome Measures

Primary Outcomes (1)

• Tolerance time

  Primary outcome is tolerance time, maximized to Three minutes, tested using the Cold Pressure test

  24 weeks

Secondary Outcomes (11)

• Pain experience measured by a pressure algometry test

  24 weeks

• Possible pain change measured by a pressure algometry test

  24 weeks

• Subjective experience of pain measured using Numeric Rating Scale (NRS)

  24 weeks

• Possible pain change measured using Numeric Rating Scale (NRS) 0-10

  24 weeks

• Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS)

  24 weeks

Study Arms (2)

Mecobalamine 5 mg/ml

ACTIVE COMPARATOR

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

Drug: Mecobalamin 5 MG

NaCl 9mg/ml

PLACEBO COMPARATOR

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

Other: Placebo Comparator : NaCl 9 mg/ml

Interventions

Mecobalamin 5 MG DRUG

The Active substance of vitamin B12 is Mecobalamin 5 mg/ml is given intramuscularly

Mecobalamine 5 mg/ml

Placebo Comparator : NaCl 9 mg/ml OTHER

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

NaCl 9mg/ml

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Linnaeus University: lead
• Landstinget i Kalmar Län: collaborator
• Region Östergötland: collaborator
• Karolinska Institutet: collaborator
• Kronoberg County Council: collaborator

Study Sites (1)

Linnaeus University

Vaxjo, Kronoberg County, 352 91, Sweden

Location

Related Publications (1)

• Sall Hansson K, Lindqvist G, Stening K, Fohlman J, Wojanowski A, Ponten M, Jensen K, Gerdle B, Elmqvist C. Efficacy of mecobalamin (vitamin B12) in the treatment of long-term pain in women diagnosed with fibromyalgia: protocol for a randomised, placebo-controlled trial. BMJ Open. 2023 Mar 30;13(3):e066987. doi: 10.1136/bmjopen-2022-066987.

  PMID: 36997252 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

mecobalamin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carina Elmqvist, Ass prof

  Linnaeus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Randomized controlled trial with Three-month follow up

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: August 17, 2021
• Study Start: February 6, 2019
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: from 2025 - 2035
• Access Criteria: anyone requesting the metadata can access the data

Locations

SE (1)