Trial Outcomes & Findings for A Placebo Controlled, Randomized, Double Blind Trial of Milnacipran for the Treatment of Idiopathic Neuropathy Pain (NCT NCT01288937)

Last Updated: 2020-09-03

Results Overview

The Likert Pain Scale Score is a psychometric scale commonly involved in research that employs questionnaires to measure the intensity of pain. It is used to determine the level of pain for research participants. The minimum score of 0 indicates "no pain" which is the better score and the maximum and total score of 10 indicates the "the worst possible pain" which is the worse outcome . Scores 1-3= Mild, scores 4-6= Moderate, scores 7-10= Severe. It is the most widely used approach to scaling responses in survey research. Patients will fill out a pain diary from baseline to end of treatment. This will be used to assess if there was a reduction in pain of the daily averaged weekly 0-10 pain scale at week 9 compared to the baseline. The Unit of Measure is the scores on the scale.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

6 participants

Primary outcome timeframe

Baseline, 9 weeks

Results posted on

2020-09-03

Participant Flow

Patients will be recruited from the practices of the investigators of the peripheral neuropathy center. These subjects will already be receiving treatment in the clinics and private practices of neurologists at the Neurological Institute. Patients will also be recruited from physician referrals and advertising.

Prior to randomization, subjects are assessed at baseline with neurological examinations, physical examination and pain questionnaire/diary.

Participant milestones

Participant milestones
Measure	Milnacipran Patients will be randomly assigned to receive milnacipran 100 mg/day (including a 1 week dose titration period): Day 1: 12.5 mg once Day 2, 3: 25 mg/day (12.5 mg twice daily) Day 4, 7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily)	Placebo Patients will be randomly assigned to placebo for 9 weeks (including a 1 week dose titration period).
Overall Study STARTED	4	2
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Milnacipran Patients will be randomly assigned to receive milnacipran 100 mg/day (including a 1 week dose titration period): Day 1: 12.5 mg once Day 2, 3: 25 mg/day (12.5 mg twice daily) Day 4, 7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily)	Placebo Patients will be randomly assigned to placebo for 9 weeks (including a 1 week dose titration period).
Overall Study Adverse Event	1	0

Baseline Characteristics

A Placebo Controlled, Randomized, Double Blind Trial of Milnacipran for the Treatment of Idiopathic Neuropathy Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Milnacipran n=4 Participants Patients will be randomly assigned to receive milnacipran 100 mg/day (including a 1 week dose titration period): Day 1: 12.5 mg once Day 2, 3: 25 mg/day (12.5 mg twice daily) Day 4, 7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily)	Placebo n=2 Participants Patients will be randomly assigned to placebo for 9 weeks (including a 1 week dose titration period).	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 9 weeks

Population: For the milnacipran arm, 4 subjects were enrolled; however, 1 subject did not complete the study (due to AE: stomach pain) and was not included in the outcome measure data collection/analysis.

Outcome measures

Outcome measures
Measure	Milnacipran n=3 Participants Patients will be randomly assigned to receive milnacipran 100 mg/day (including a 1 week dose titration period): Day 1: 12.5 mg once Day 2, 3: 25 mg/day (12.5 mg twice daily) Day 4, 7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily)	Placebo n=2 Participants Patients will be randomly assigned to placebo for 9 weeks (including a 1 week dose titration period).
Likert Pain Scale Score Baseline	5.6 Scores on a scale Interval 3.1 to 8.0	7.15 Scores on a scale Interval 5.7 to 8.6
Likert Pain Scale Score 9 Weeks	3.2 Scores on a scale Interval 1.4 to 6.6	5.15 Scores on a scale Interval 4.3 to 6.0

Adverse Events

Milnacipran

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Milnacipran n=4 participants at risk Patients will be randomly assigned to receive milnacipran 100 mg/day (including a 1 week dose titration period): Day 1: 12.5 mg once Day 2, 3: 25 mg/day (12.5 mg twice daily) Day 4, 7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily)	Placebo n=2 participants at risk Patients will be randomly assigned to placebo for 9 weeks (including a 1 week dose titration period).
Reproductive system and breast disorders Erectile Dysfunction	25.0% 1/4 • Number of events 1 • Baseline to 9 weeks. The definition of adverse event (AE) and/or serious adverse event used to collect AE information is the same as the ClinicalTrials.gov definitions.	0.00% 0/2 • Baseline to 9 weeks. The definition of adverse event (AE) and/or serious adverse event used to collect AE information is the same as the ClinicalTrials.gov definitions.
Gastrointestinal disorders Stomach Pain	25.0% 1/4 • Baseline to 9 weeks. The definition of adverse event (AE) and/or serious adverse event used to collect AE information is the same as the ClinicalTrials.gov definitions.	0.00% 0/2 • Baseline to 9 weeks. The definition of adverse event (AE) and/or serious adverse event used to collect AE information is the same as the ClinicalTrials.gov definitions.

Additional Information

Thomas H. Brannagan, MD

Columbia University

Phone: (212) 305-0405

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place