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NCT05384210
Effect of Milnacipran Versus Gabapentin or Combination of Both in Fibromyalgia Syndrome
NA trial testing Milnacipran in Fibromyalgia in 75 participants. Status unknown.
1 October 2023
Quick facts
| Lead sponsor | Mansoura University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 75 |
| Start date | 1 June 2022 |
| Primary completion | 1 October 2023 |
| Estimated completion | 1 November 2023 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Milnacipran — full drug profile →
- Gabapentin (Gabapentin) — full drug profile →
- Combined gabapentin/milnacipran — full drug profile →
Conditions studied
- Fibromyalgia — all drugs for Fibromyalgia →
Sponsor
Mansoura University
Who can join
Adults 18 to 70, female only, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Neuro-Immune Crosstalk: Molecular Mechanisms, Biological Functions, Diseases, and Therapeutic Targets.
Guo X, Liu H, Song YJ, Wang JH, et al · · 2026 · cited 2× · PMID 41583906 · DOI 10.1002/mco2.70497
Verify or expand the search:
- PubMed search for NCT05384210
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Milnacipran
Trials testing the same drug.
- NCT02783430 — Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease · Phase 2, PHASE3 · completed
- NCT01328002 — Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia · Phase 2 · terminated
- NCT01288937 — A Placebo Controlled, Randomized, Double Blind Trial of Milnacipran for the Treatment of Idiopathic Neuropathy Pain · Phase 3 · terminated
Other recruiting trials for Fibromyalgia
Currently open trials in the same condition.
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- NCT07358754 — The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor · recruiting
- NCT07465991 — The Effect of Digital Cognitive Behavioural Therapy for Insomnia on Physical Activity in Fibromyalgia · NA · recruiting
Other Mansoura University trials
Trials by the same sponsor.
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- NCT07509567 — Conventional Palatal Crib Versus Bonded Spurs for Anterior Open Bite Treatment · NA · not yet recruiting
- NCT07393178 — Efficacy & Safety of High Power vs. Low Power Holmium Laser in Mini-PCNL for Large Renal Stones · NA · not yet recruiting
- NCT07436182 — Mitochondrial Redox Modulation in Newly Diagnosed Type 2 Diabetes: A Randomized Controlled Trial Comparing Imeglimin vs. · Phase 4 · not yet recruiting
- NCT07534943 — Effectiveness of Oleanolic Acid as Intracanal Medicament on Infectious/Inflammatory Contents in Teeth With Apical Period · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05384210 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mansoura University
- Last refreshed: 17 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05384210.
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