FibromyalgiaNCT05384210
Effect of Milnacipran / Gabapentin in Fibromyalgia
A study testing Milnacipran, Gabapentin and Combined gabapentin/milnacipran in people with Fibromyalgia, run by Mansoura University at 1 site in Egypt.
Trial summary
Gabapentin and milnacipran (MLN) show strong evidence of reduced pain, increased sleep, and improvement in the quality of life in fibromyalgia (FM) patients. Most FM trials focus primarily on pain reduction with monotherapy. Polypharmacy is commonly used, but supportive evidence is limited. 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?
- Milnacipran, Gabapentin and Combined gabapentin/milnacipran
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2022to Nov 2023
- Phase
- Interventional
- 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
- There are no other criteria rather than age and sex
Who cannot join
- Patient refusal.
- Pregnancy or breastfeeding.
- Active liver disease
- Renal impairment (creatinine clearance < 60 mL/min).
- Documented autoimmune disease.
- Severe chronic obstructive pulmonary disease.
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- Recent arrhythmia
- Myocardial infarction
- Stroke.
- Uncontrolled hypertension.
- Glaucoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Milnacipran Versus Gabapentin or Combination of Both in Fibromyalgia Syndrome
Gabapentin and milnacipran (MLN) show strong evidence of reduced pain, increased sleep, and improvement in the quality of life in fibromyalgia (FM) patients.
Most FM trials focus primarily on pain reduction with monotherapy. Polypharmacy is commonly used, but supportive evidence is limited.
The gabapentin-MLN combined therapy may be more effective in female patients with FM than their monotherapy.
Read the detailed description
The aim of the study is to evaluate the analgesic efficacy of gabapentin-MLN as combined or monotherapy on patients with FM.
- Conditions
- Fibromyalgia
- Being tested
- Milnacipran, Gabapentin, Combined gabapentin/milnacipran
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilnacipranDrug
Milnacipran will be administered according to the treatment recommendations for fibromyalgia, starting with 50 mg once daily for 1 week then increasing to reach 100 mg daily (50 mg twice daily) based on efficacy and tolerability for 3 months.
GabapentinDrug
Patients will receive gabapentin (1200 mg twice daily) as a monotherapy. Gabapentin will be administered according to the treatment recommendations for FM patients starting with 400 mg 3 times per day, then increasing the dose to 800 mg 3 times per day with a maximum dose of 2400 mg per day according to efficacy and tolerability for 3 months
Combined gabapentin/milnacipranDrug
Patients will receive combined gabapentin as group B and MLN as group A
| Study group | Role | What they receive |
|---|---|---|
| Milnacipran | Active comparator | Patients will receive Milnacipran as a mono-therapy will be administered in increment doses for 3 months Receives: Drug: Milnacipran |
| Gabapentin | Active comparator | patients will receive Gabapentin as a mono-therapy will be administered in increment doses for 3 months Receives: Drug: Gabapentin |
| Combined gabapentin/milnacipran | Active comparator | Patients will receive combined gabapentin and milnacipran as a combination therapy will be administered in increment doses for 3 months Receives: Drug: Combined gabapentin/milnacipran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS) for pain
Assesses the overall pain of fibromyalgia on a 10 cm pain scale with 0 indicating no pain and 10 indicating the worst pain ever
Measured: 3 months
Secondary outcomes (2)
The Fibromyalgia Impact Questionnaire (FIQ).
Assesses the overall functional ability and the impact of fibromyalgia on the patient's life, with a range from 0-100, 0 indicating no functional impairment or effect of the disease on the patient's life and 100 indicating a very bad and tremendous effect of fibromyalgia on the patient's life.
Measured: 3 months
Leeds Sleep Evaluation Questionnaire
The four aspects of sleep around which the questionnaire is devised (Getting to sleep, GTS; Quality of sleep, QOS; Awakening from sleep, AFS; Behaviour following wakefulness, BFW), and assessing the effect of medication on the quality of sleep each question is a 100 mm line that the patient marks, 0 meaning very bad effect or worsening in sleep pattern, 50 meaning no improvement what so ever with no deterioration and 100 meaning excellent improvement in the sleep pattern
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study startJun 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amr M Yassin, MD, Study chair, Professor of Anesthesia and Surgical Intensive CareEiad A Ramzy, md, Study director, Assistant Professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384210
- Sponsor's protocol ID
- MFM-IRB، MD.21.12.577
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Milnacipran Versus Gabapentin or Combination of Both in Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT05384210
- Acronym / sponsor ID
- MFM-IRB، MD.21.12.577
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 20 May 2022 (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.
Gabapentin and milnacipran (MLN) show strong evidence of reduced pain, increased sleep, and improvement in the quality of life in fibromyalgia (FM) patients.
Most FM trials focus primarily on pain reduction with monotherapy. Polypharmacy is commonly used, but supportive evidence is limited.
The gabapentin-MLN combined therapy may be more effective in female patients with FM than their monotherapy.
Detailed description
The aim of the study is to evaluate the analgesic efficacy of gabapentin-MLN as combined or monotherapy on patients with FM.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Milnacipran | Active comparator | Drug: MilnacipranPatients will receive Milnacipran as a mono-therapy will be administered in increment doses for 3 months |
| Gabapentin | Active comparator | Drug: Gabapentinpatients will receive Gabapentin as a mono-therapy will be administered in increment doses for 3 months |
| Combined gabapentin/milnacipran | Active comparator | Drug: Combined gabapentin/milnacipranPatients will receive combined gabapentin and milnacipran as a combination therapy will be administered in increment doses for 3 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- There are no other criteria rather than age and sex
Key exclusion criteria (11 listed)
- Patient refusal.
- Pregnancy or breastfeeding.
- Active liver disease
- Renal impairment (creatinine clearance < 60 mL/min).
- Documented autoimmune 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 |
|---|---|---|
| MilnacipranMilnacipran will be administered according to the treatment recommendations for fibromyalgia, starting with 50 mg once daily for 1 week then increasing to reach 100 mg daily (50 mg twice daily) based on efficacy and tolerability for 3 months. | Drug | Milnacipran |
| GabapentinPatients will receive gabapentin (1200 mg twice daily) as a monotherapy. Gabapentin will be administered according to the treatment recommendations for FM patients starting with 400 mg 3 times per day, then increasing the dose to 800 mg 3 times per day with a maximum dose of 2400 mg per day according to efficacy and tolerability for 3 months | Drug | Gabapentin |
| Combined gabapentin/milnacipranPatients will receive combined gabapentin as group B and MLN as group A | Drug | Combined gabapentin/milnacipran |
Primary outcome
Visual analogue scale (VAS) for pain
Time frame: 3 months
Assesses the overall pain of fibromyalgia on a 10 cm pain scale with 0 indicating no pain and 10 indicating the worst pain ever
2 secondary outcomes
The Fibromyalgia Impact Questionnaire (FIQ).
Time frame: 3 months
Leeds Sleep Evaluation Questionnaire
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Individual participant dataSharing planned: Yes. Yes, Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
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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.
Amr M Yassin, MD study chair
Professor of Anesthesia and Surgical Intensive Care
Eiad A Ramzy, md study director
Assistant Professor of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milnacipran, Gabapentin and Combined gabapentin/milnacipran in people with Fibromyalgia, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 May 2022. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Visual analogue scale (VAS) for pain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2022.