Trial Outcomes & Findings for The Effect of Milnacipran in Patients With Fibromyalgia (NCT NCT01108731)

Results Overview

Ventricular lactate levels will be assessed before and at the end of the trial using a scanning method known as magnetic resonance spectroscopy (MRS), which is used to determine the presence and quantity of a number of chemicals in the brain.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

37 participants

Primary outcome timeframe

Baseline and 2 months

Results posted on

2016-06-30

Participant Flow

We got informed consent from 37 patients but excluded 3 -- 2 for saving psychiatric diagnoses that were exclusionary and one for having a metal implant which was an exclusion for neuroimaging. Thus 34 patients were randomized for the trial.

Participant milestones

Participant milestones
Measure	Patients Taking the Drug Minalcipran Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.	Patients Taking the Placebo Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.
Overall Study STARTED	17	17
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients Taking the Drug Minalcipran Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.	Patients Taking the Placebo Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	3	3

Baseline Characteristics

The Effect of Milnacipran in Patients With Fibromyalgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Taking the Drug Minalcipran n=13 Participants Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.	Patients Taking the Placebo n=13 Participants Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.	Total n=26 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 4 • n=5 Participants	47 years STANDARD_DEVIATION 5 • n=7 Participants	47 years STANDARD_DEVIATION 4 • n=5 Participants
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	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 2 months

Population: One drug treated and two placebo treated could not be analyzed due to excessive head motion

Ventricular lactate levels will be assessed before and at the end of the trial using a scanning method known as magnetic resonance spectroscopy (MRS), which is used to determine the presence and quantity of a number of chemicals in the brain.

Outcome measures

Outcome measures
Measure	Patients Taking the Drug Minalcipran n=12 Participants Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.	Patients Taking the Placebo n=11 Participants Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.
Change in Ventricular Lactate Levels in the Brain	-0.87 international units (iu) Standard Deviation 0.91	0.32 international units (iu) Standard Deviation 1.58

SECONDARY outcome

Timeframe: Baseline and 2 months

Population: Data from 4 were excluded due to 2 having error rates greater than 50%, indicating that they did not understand the task and 2 having simple reaction times longer than those for the complex reaction times on the ANT, suggesting their need for additional practice trials on the simple motor reaction time task.

The Attention Network Test (ANT) is a computerized test designed to evaluate the efficiency of the attention network. The ANT consists of a set of cued reaction time tasks to assess vigilance and efficiency to detect novel visual stimuli. The ANT also includes a set of flanker tasks during which a decision needs to be made about whether the orientation of a central stimulus is congruent or incongruent with a set of flanking arrows. Scores on the cued reaction time tasks (no cue, centre cue, double cue) reflect latency to respond measured in milliseconds (slower performance equals greater values). The score on the flanker task reflecting executive attention is derived by subtracting obtained latencies on the congruent flanker from the incongruent condition. Based on our prior work, we are hypothesizing that drug treated Ss will show improved performance on the no cue reaction time condition and on the derived executive attention variable compared to placebo treated.

Outcome measures

Outcome measures
Measure	Patients Taking the Drug Minalcipran n=11 Participants Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.	Patients Taking the Placebo n=11 Participants Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.
Change in Cognitive Function Assessed by the no Cue Condition of the Attention Network Test (ANT). Executive attention	-68.73 latency to respond (msecs.) Standard Deviation 52.77	-34.77 latency to respond (msecs.) Standard Deviation 52.77
Change in Cognitive Function Assessed by the no Cue Condition of the Attention Network Test (ANT). No cue condition	-79.56 latency to respond (msecs.) Standard Deviation 80.45	-35.00 latency to respond (msecs.) Standard Deviation 90.09

SECONDARY outcome

Timeframe: 2 months

Population: Data from all 26 participants were used for analysis.

Pain was assessed using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst pain ever). The baseline value recorded was widespread pain at the time of assessment and the 2 months follow value recorded was widespread pain over the week prior to assessment.

Outcome measures

Outcome measures
Measure	Patients Taking the Drug Minalcipran n=13 Participants Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.	Patients Taking the Placebo n=13 Participants Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.
Change in Widespread Pain	-1.24 units on a scale Standard Deviation 1.57	0.66 units on a scale Standard Deviation 1.75

Adverse Events

Patients Taking the Drug Minalcipran

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Patients Taking the Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patients Taking the Drug Minalcipran n=17 participants at risk Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.	Patients Taking the Placebo n=17 participants at risk Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.
Gastrointestinal disorders Gastric distress, nausea or vomiting	11.8% 2/17 • During the 2 month trial	5.9% 1/17 • During the 2 month trial

Additional Information

Dr Benjamin Natelson

Beth_IsraelMC

Phone: 212-844-6747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place