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Effect of Milnacipran / Gabapentin in Fibromyalgia

Primary Purpose

Fibromyalgia

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Milnacipran

Gabapentin

Combined gabapentin/milnacipran

About this trial

This is an interventional supportive care trial for Fibromyalgia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

There are no other criteria rather than age and sex

Exclusion Criteria:

Patient refusal.
Pregnancy or breastfeeding.
Active liver disease
Renal impairment (creatinine clearance < 60 mL/min).
Documented autoimmune disease.
Severe chronic obstructive pulmonary disease.
Recent arrhythmia
Myocardial infarction
Stroke.
Uncontrolled hypertension.
Glaucoma.

Sites / Locations

Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Milnacipran

Gabapentin

Combined gabapentin/milnacipran

Arm Description

Patients will receive Milnacipran as a mono-therapy will be administered in increment doses for 3 months

patients will receive Gabapentin as a mono-therapy will be administered in increment doses for 3 months

Patients will receive combined gabapentin and milnacipran as a combination therapy will be administered in increment doses for 3 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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

Full Information

NCT ID

NCT05384210

First Posted

May 17, 2022

Last Updated

May 17, 2022

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT05384210

Brief Title

Effect of Milnacipran / Gabapentin in Fibromyalgia

Official Title

Effect of Milnacipran Versus Gabapentin or Combination of Both in Fibromyalgia Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

June 2022 (Anticipated)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Milnacipran

Arm Type

Active Comparator

Arm Description

Patients will receive Milnacipran as a mono-therapy will be administered in increment doses for 3 months

Arm Title

Gabapentin

Arm Type

Active Comparator

Arm Description

patients will receive Gabapentin as a mono-therapy will be administered in increment doses for 3 months

Arm Title

Combined gabapentin/milnacipran

Arm Type

Active Comparator

Arm Description

Patients will receive combined gabapentin and milnacipran as a combination therapy will be administered in increment doses for 3 months

Intervention Type

Drug

Intervention Name(s)

Milnacipran

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Gabapentin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Combined gabapentin/milnacipran

Intervention Description

Patients will receive combined gabapentin as group B and MLN as group A

Primary Outcome Measure Information:

Title

Visual analogue scale (VAS) for pain

Description

Assesses the overall pain of fibromyalgia on a 10 cm pain scale with 0 indicating no pain and 10 indicating the worst pain ever

Time Frame

3 months

Secondary Outcome Measure Information:

Title

The Fibromyalgia Impact Questionnaire (FIQ).

Description

Time Frame

3 months

Title

Leeds Sleep Evaluation Questionnaire

Description

Time Frame

3 months

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: There are no other criteria rather than age and sex Exclusion Criteria: Patient refusal. Pregnancy or breastfeeding. Active liver disease Renal impairment (creatinine clearance < 60 mL/min). Documented autoimmune disease. Severe chronic obstructive pulmonary disease. Recent arrhythmia Myocardial infarction Stroke. Uncontrolled hypertension. Glaucoma.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amr M Yassin, MD

Organizational Affiliation

Professor of Anesthesia and Surgical Intensive Care

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Eiad A Ramzy, md

Organizational Affiliation

Assistant Professor of Anesthesia and Surgical Intensive Care

Official's Role

Study Director

Facility Information:

Facility Name

Mansoura University

City

Mansoura

State/Province

ZIP/Postal Code

050

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Yes, Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)

IPD Sharing Time Frame

After completing the study and being accepted for publication.

IPD Sharing Access Criteria

The data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients.

Learn more about this trial

Effect of Milnacipran / Gabapentin in Fibromyalgia

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