FibromyalgiaPhase 1/2NCT05008042
Evaluation of the Efficiacy of Mecobalamine in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia
A Phase 1/2 study testing Mecobalamin 5 MG in people with Fibromyalgia, run by Linnaeus University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Mecobalamin 5 MG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 6 Feb 2019to 26 Mar 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- Known neuropathy (impaired sensation)
- Breastfeeding
- Pregnancy or plan pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficiacy of Mecobalamine (Vit B12) in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia: Single-blind Randomized Controlled Trial With Three-month Follow up
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
- Being tested
- Mecobalamin 5 MG, Placebo Comparator : NaCl 9 mg/ml
- Keywords
- Fibromyalgia,, Chronic pain,, Mekobalamin,, Randomized Controlled Trial, VitaminB12
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mecobalamin 5 MGDrug
The Active substance of vitamin B12 is Mecobalamin 5 mg/ml is given intramuscularly
Placebo Comparator : NaCl 9 mg/mlOther
Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) is given intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo Comparator : NaCl 9 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance time
Primary outcome is tolerance time, maximized to Three minutes, tested using the Cold Pressure test
Measured: 24 weeks
Secondary outcomes (11)
Pain experience measured by a pressure algometry test
Pain experience measured by a pressure algometry test performed on the shoulder, hip, knee and elbow.
Measured: 24 weeks
Possible pain change measured by a pressure algometry test
Possible pain change measured by a pressure algometry test performed on the shoulder, hip, knee and elbow.
Measured: 24 weeks
Subjective experience of pain measured using Numeric Rating Scale (NRS)
Subjective experience of pain measured using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome .
Measured: 24 weeks
Possible pain change measured using Numeric Rating Scale (NRS) 0-10
Possible pain change measured using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome .
Measured: 24 weeks
Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS)
Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome.
Measured: 24 weeks
Ratings of expectation, pain variability, using Numeric Rating Scale (NRS) 0-10
Ratings of expectation, pain variability, using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome.
Measured: 24 weeks
Activity level, assessed using questionnaire McGills Pain Questionnaire (MPQ).
Activity level are assessed using questionnaire McGills Pain Questionnarie (MPQ). Short version score 0-45.
Measured: 24 weeks
Quality of Life are assessed using questionnaires RAND-36.
Quality of life are assessed using questionnaires RAND-36 score 0-100
Measured: 24 weeks
Experience of the effect of the drug, assessed using questionnaire Patients´ Global Impression of Change (PGIC).
Experience of the effect of the drug, score 1-7
Measured: 24 weeks
Cobalamin in plasma
Control of vitamin B12 is done by measuring cobalamin in plasma.
Measured: 24 weeks
Lived experiences of pain, health, suffering and well-being.
Qualitative in-depth interviews will be conducted to capture women's lived experiences of pain, health, suffering and well-being.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start6 Feb 2019
- Primary completion26 Mar 2024
- Study completion26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with Three-month follow up
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linnaeus University
- Sponsor type
- University, hospital or other
- Collaborators
- Landstinget i Kalmar Län, Region Östergötland, Karolinska Institutet, Kronoberg County Council
- Responsible party
- Principal investigator, Carina Elmqvist, Linnaeus University
- Investigators
- Carina Elmqvist, Ass prof, Principal investigator, Linnaeus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008042
- Sponsor's protocol ID
- EUDRACT 2015-005086-23
- Status last verified
- Dec 2024
- First submitted
- 30 Jun 2021
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Metadata and analysis scripts
Publications
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.
PubMed 36997252
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiacy of Mecobalamine (Vit B12) in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia: Single-blind Randomized Controlled Trial With Three-month Follow up
- ClinicalTrials.gov ID
- NCT05008042
- Acronym / sponsor ID
- EUDRACT 2015-005086-23
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia,, Chronic pain,, Mekobalamin,, Randomized Controlled Trial, VitaminB12
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Linnaeus UniversityUniversity, hospital or other
- Collaborators
- Landstinget i Kalmar Län, Region Östergötland, Karolinska Institutet, Kronoberg County Council
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized controlled trial with Three-month follow up
| Arm | Type | Receives |
|---|---|---|
| Mecobalamine 5 mg/ml | Active comparator | Drug: Mecobalamin 5 MGThe active substance of vitamin B12 given in the study is Mecobalamin 5mg / ml 2 ml ie 10 mg and is given intramuscularly. |
| NaCl 9mg/ml | Placebo comparator | Other: Placebo Comparator : NaCl 9 mg/mlPlacebo substance given in the study is Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) given intramuscularly. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mecobalamin 5 MGThe Active substance of vitamin B12 is Mecobalamin 5 mg/ml is given intramuscularly | Drug | Mecobalamine 5 mg/ml |
| Placebo Comparator : NaCl 9 mg/mlSodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) is given intramuscularly. | Other | NaCl 9mg/ml |
Primary outcome
Tolerance time
Time frame: 24 weeks
Primary outcome is tolerance time, maximized to Three minutes, tested using the Cold Pressure test
11 secondary outcomes
Pain experience measured by a pressure algometry test
Time frame: 24 weeks
Possible pain change measured by a pressure algometry test
Time frame: 24 weeks
Subjective experience of pain measured using Numeric Rating Scale (NRS)
Time frame: 24 weeks
Possible pain change measured using Numeric Rating Scale (NRS) 0-10
Time frame: 24 weeks
Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS)
Time frame: 24 weeks
Ratings of expectation, pain variability, using Numeric Rating Scale (NRS) 0-10
Time frame: 24 weeks
Activity level, assessed using questionnaire McGills Pain Questionnaire (MPQ).
Time frame: 24 weeks
Quality of Life are assessed using questionnaires RAND-36.
Time frame: 24 weeks
Experience of the effect of the drug, assessed using questionnaire Patients´ Global Impression of Change (PGIC).
Time frame: 24 weeks
Cobalamin in plasma
Time frame: 24 weeks
Lived experiences of pain, health, suffering and well-being.
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Derived from this study: PubMed 36997252Sall 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.
- Individual participant dataSharing planned: Yes. Metadata and analysis scripts
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carina Elmqvist, Ass prof principal investigator
Linnaeus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mecobalamin 5 MG in people with Fibromyalgia, run by Linnaeus University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance time (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05008042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.