Mekobalamin's (Vitamin B12) effect on long-term pain in women with fibromyalgi.

Phase 1

• Conditions: Fibromyalgia; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2015-005086-23-SE
• Lead Sponsor: innéuniversitetet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-20
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

*Swedish speaking women between 20-70 years
*Diagnosed with fibromyalgia
*Conscent to the trial
* Use a safe birth control method such as birth control pills, p-rod, p-syringe, p-patch, hormone coil, copper coil
*-Renal function value
GFR >60 mL/min/1,73 m2
*Liver function value:
P-ALP 0,6-2,85 µkat/L
P-ALAT 0,15-1,13 µkat/L
*Cardiac function value
Troponin-T < 15 ng/L
NT-pro-BNP >125 <450 <50 years
NT-pro-BNP >300 <900 50-75 years
*Kobalamin >250 pmol/L < 800 pmol/L

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

*use of neuroleptics (antipsychotic treatment)
*have Reynaud's phenomenon (white finger)
* neuropathi (numbness)
*vegan
*previous treatment with Vitamin B12
*cardiac, hepatic or renal impairment
*hypersensitivity to the active substance or any of the excipients
*pregnant or planning to become pregnant
*breast feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate if fibromyalgia patients who get Mekobalamin (Vitamin B12) injections once a week can reduce their pain sensitivity compared to placebo.;Secondary Objective: To evaluate if patients who get vitamin B12-injections can: <br>*reduce their pain intensity<br>*obtain a higher level of activity and a better quality of Life<br>* the study drug's effect<br>*safety of the study drug<br>*how patients describe their pain, health, sufferness and well-being<br>*Also to evaluate how patients with fibromyalgia experience to live with long-term pain<br>;Primary end point(s): Tolerance time(seconds) the subjects has his hand in the cold water bath using the Cold Pressure Test.;Timepoint(s) of evaluation of this end point: 12 weeks and 24 weeks after first injection compared to before treatment start.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pain measured by NRS 0-100.<br>Score at questionaire: RAND-36 and MPQ<br>Effect of treatment measured by PGIC;Timepoint(s) of evaluation of this end point: 12 weeks and 24 weeks after first injection compared to before treatment start.