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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005086-23-SE

Enrollment

Registered

2018-04-20

Start date

2018-06-13

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Interventions

Trade Name: Mekobalamin Product Name: Mekobalamin Pharmaceutical Form: Concentrate for solution for injection Pharmaceutical form of the placebo: Concentrate for solution for injection Route of admini

Eligibility

Sex/Gender

All

Inclusion criteria

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 125 300 250 pmol/L =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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: reduce their pain intensity obtain a higher level of activity and a better quality of Life * the study drug's effect safety of the study drug how patients describe their pain, health, sufferness and well-being *Also to evaluate how patients with fibromyalgia experience to live with long-term pain ;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.	—

Measure

Time frame

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: *reduce their pain intensity *obtain a higher level of activity and a better quality of Life * the study drug's effect *safety of the study drug *how patients describe their pain, health, sufferness and well-being *Also to evaluate how patients with fibromyalgia experience to live with long-term pain ;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.

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Secondary

Measure	Time frame
Secondary end point(s): Pain measured by NRS 0-100. Score at questionaire: RAND-36 and MPQ 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.	—

Countries

Sweden

Contacts

Public ContactInstitutionen för hälso-och vårdvet

Linnéuniversitetet

carina.elmqvist@lnu.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026