Study Evaluated the Effectiveness of Milnacipran to Reduce Pain Levels in Individuals With Chronic Migraine

NCT01393522 | Completed Results

• 1 other identifier: SAV-MD-25
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if milnacipran taken twice daily is effective in reduction of headache pain.

Conditions

Chronic Migraine

Keywords

headache; migraine

Outcome Measures

Primary Outcomes (4)

• Change in VAS Pain Severity

  On headache days, patients were instructed to complete a Visual Analog Scale (VAS) to rate their pain intensity. Their response (the scale was 100 cm long) was measured and assigned a score (0-100) with higher numbers indicating more severity. Scores were averaged over a 30 day period to create the score for a time period (baseline and 90 days). Change in Pain score = Score\[Baseline\] - Score\[90 days\]. Higher scores indicate greater pain reduction.

  Baseline and 90 days

• Change in Migraine Specific Quality of Life - Restrictive

  The Migraine Specific Quality of Life measures the impact Migraine has on the patient's Quality of Life. The Restrictive subscale assesses the extent to which migraine restricts the patient's function. The subscale is measured on a standard scale from 0-100, where higher scores indicate better quality of life. For the outcome assessing change, higher positive scores indicate better outcomes.

  Baseline and 90 days

• Change in Migraine Specific Quality of Life - Preventive

  The Migraine Specific Quality of Life measures the impact Migraine has on the patient's Quality of Life. The Preventive subscale assesses the extent to which migraine prevents the patient's function. The subscale is measured on a standard scale from 0-100, where higher scores indicate better quality of life. For the outcome assessing change, higher positive scores indicate better outcomes.

  Baseline and 90 days

• Change in Migraine Specific Quality of Life - Emotional

  The Migraine Specific Quality of Life measures the impact Migraine has on the patient's Quality of Life. The Emotional subscale assesses the extent to which migraine influences the patient's emotional function. The subscale is measured on a standard scale from 0-100, where higher scores indicate better quality of life. For the outcome assessing change, higher positive scores indicate better outcomes.

  Baseline and 90 days

Secondary Outcomes (3)

• Change in Days With Migraine Per Month From Baseline to 90 Days

  Baseline and 90 days

• Change in Days With Non-Migraine Headache Per Month From Baseline to 90 Days

  Baseline and 90 days

• Change in Days Using Headache Medication Per Month From Baseline to 90 Days

  Baseline and 90 days

Study Arms (2)

Milnacipran

ACTIVE COMPARATOR

Oral Milnacipran titration was Day 1-2 - 12.5mg/d; Day 3-6 - 12.5mg bid; Day 7-14 - 25mg bid; Day 15 and on - 50mg bid. After the first 30 days, patients did not continue to increase the dose beyond the dose they have achieved at 30 days. At study completion medication taper as follows: patients who at their completion visit were taking 50mg bid decreased to 25mg bid for 4 days, then decreased to 12.5mg bid for 2 days, then 12.5mg once a day for one day and then stopped. Patients on 25mg bid, decreased to 12.5mg bid for 2 days, 12.5mg once a day for one day and then stopped.

Drug: Milnacipran

Placebo

PLACEBO COMPARATOR

Sugar Pill No active ingredients

Drug: Placebo

Interventions

Milnacipran DRUG

titration schedule starting with 12.5mg per day increasing to 50mg twice a day, starting with day 1 to day 90 and then taper down as appropriate for dose.

Also known as: Savella

Milnacipran

Placebo DRUG

Placebo dosing schedule was Day 1-2, 1 tablet daily, Day 3-6 BID, Day 7-14 BID, Day 15 an on through day 90 BID and taper down

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals between the age of 18 and 65
• Headache fulfills ICHD-2 criteria for: chronic migraine, or probable medication overuse headache where individual headaches meet criteria for migraine
• At least 15 headache days/month and at least 8 migraine or probable migraine days/month for the past 3 months, by patient report (including days of headache relieved with a triptan or related compound).
• Age at onset of chronic migraine \< 60 years old

You may not qualify if:

• Pregnancy or attempting conception
• Unable to read or write English
• Use of Opiates \>/= 10 days per month
• Subject has failed \>/= 4 adequate preventive trials of antidepressant medications due to lack of efficacy; at least one trial included another SNRI.(An adequate preventive trial defined as at least 6 weeks on therapeutic dose \[150mg of amitriptyline or nortriptyline or other tricyclic, 150mg of venlafaxine, 60mg of duloxetine\])
• Subjects on antidepressant medications, including SNRIs who cannot safely withdraw from those medications, in the assessment of the PI. Subjects on other headache preventives (beta blockers, antiepileptic drugs), at stable dose for at least three months, will be allowed to participate.
• A. Subjects on other headache preventives may be included in the study if the medication has been at a stable dose for 3 months.
• Presence of fibromyalgia or another pain or medical disorder that would make it difficult for patient to distinguish headache-related quality of life from overall health related quality of life.
• Uncontrolled or unstable psychiatric disorder (PHQ-9 score or GAD-7 score \>15 with sentinel questions \>/=4, or in opinion of examiner), or anticipated need for change in psychotropic medications during duration of study period; or suicidality.
• Chronic kidney disease, liver disease, or any poorly controlled medical condition

Sponsors & Collaborators

• Timothy Smith: lead

Study Sites (2)

Mercy Health Research

St Louis, Missouri, 63141, United States

Location

Headache Wellness Center

Greensboro, North Carolina, 27405, United States

Location

MeSH Terms

Conditions

Headache; Migraine Disorders

Interventions

Milnacipran; Sugars

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbohydrates

Limitations and Caveats

Given that the number needed to have adequate power to demonstrate differences was 38.3% higher than the number enrolled, it is difficult to make any specific conclusions about the efficacy of Milnacipran.

Results Point of Contact

• Title: Timothy R. Smith, MD
• Organization: Mercy Health Research

Timothy.Smith@mercy.net

314-251-8895

Study Officials

• Timothy Smith, MD

  Mercy Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President of Clinical Research

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 13, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 12, 2022
• Results First Posted: August 12, 2022

Record last verified: 2022-08

Locations

US (2)