Trial Outcomes & Findings for Effect of Milnacipran on Pain in Fibromyalgia (NCT NCT01288807)
NCT ID: NCT01288807
Last Updated: 2019-09-24
Results Overview
Measure levels of Substance P present in serial samples of CSF and plasma collected over the course of 4 hours in response to application of a painful thermal stimulus at baseline ("before") and the end of 12 weeks of treatment with milnacipran 200mg daily ("after"). Substance P levels are presented. Presented data show the 10 minute and 40 minute timepoint for Substance P after pain challenge. Additional time points were not analyzed.
COMPLETED
PHASE4
8 participants
12 weeks
2019-09-24
Participant Flow
Participant milestones
| Measure |
Treatment
Titrated Milnacipram doses
Milnacipram: Titration to 200mg PO daily
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Milnacipran on Pain in Fibromyalgia
Baseline characteristics by cohort
| Measure |
Treatment
n=8 Participants
Titrated Milnacipram doses
Milnacipram: Titration to 200mg PO daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 8 patients with fibromyalgia were recruited for the study.
Measure levels of Substance P present in serial samples of CSF and plasma collected over the course of 4 hours in response to application of a painful thermal stimulus at baseline ("before") and the end of 12 weeks of treatment with milnacipran 200mg daily ("after"). Substance P levels are presented. Presented data show the 10 minute and 40 minute timepoint for Substance P after pain challenge. Additional time points were not analyzed.
Outcome measures
| Measure |
Treatment
n=8 Participants
Titrated Milnacipram doses
Milnacipram: Titration to 200mg PO daily
|
|---|---|
|
Concentration of Substance P in Cerebrospinal Fluid in Response to Experiemental Pain Before and After Milnacipran Treatment.
Baseline
|
77.2 pg/mL
Standard Deviation 26.2
|
|
Concentration of Substance P in Cerebrospinal Fluid in Response to Experiemental Pain Before and After Milnacipran Treatment.
10 min after pain challenge
|
126.7 pg/mL
Standard Deviation 18.1
|
|
Concentration of Substance P in Cerebrospinal Fluid in Response to Experiemental Pain Before and After Milnacipran Treatment.
40 min after pain challenge
|
81.0 pg/mL
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 8 patients with fibromyalgia syndrom were recruited.
Investigators will utilize quantitative sensory testing to assess changes in sensory thresholds among patients with fibromyalgia before and after a twelve (12) week course of milnacipran.
Outcome measures
| Measure |
Treatment
n=8 Participants
Titrated Milnacipram doses
Milnacipram: Titration to 200mg PO daily
|
|---|---|
|
Measure Sensory Threshold for Temperature Pain
Cold threshold before treatment
|
20.6 Degree Celcius
Standard Deviation 5.8
|
|
Measure Sensory Threshold for Temperature Pain
Cold threshold after treatment
|
8.8 Degree Celcius
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 8 patients with fibromyalgia syndrom were recruited
Investigator will utilize sensory testing to assess changes in sensory thresholds among patients with fibromyalgia before and after a twelve (12) week course of milnacipran.
Outcome measures
| Measure |
Treatment
n=8 Participants
Titrated Milnacipram doses
Milnacipram: Titration to 200mg PO daily
|
|---|---|
|
Measure Sensory Thresholds for Pressure Pain
Pressure threshold before treatment
|
15.9 lb/in(2)
Standard Deviation 5.0
|
|
Measure Sensory Thresholds for Pressure Pain
Pressure threshold after treatment
|
14.1 lb/in(2)
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 8 patients with fibromyalgia syndrom were recruited.
Fibromyalgia patients will be asked to keep a pain diary which assess spontaneous pain ratings daily, a subjective weekly assessment, as well as degree of improvement weekly during treatment period on a numeric rating scale. The Numeric Pain Rating Scale (NPRS) is assessing the patients pain on a 11-point rating scale from 0 - 10 with 0 corresponding to 'No Pain' and 10 corresponding to 'Worst Pain imaginable'.
Outcome measures
| Measure |
Treatment
n=8 Participants
Titrated Milnacipram doses
Milnacipram: Titration to 200mg PO daily
|
|---|---|
|
Measure Pain Ratings and Fibromyalgia Symptoms
Pain rating before treatment
|
4.5 score on a scale
Standard Deviation 1.7
|
|
Measure Pain Ratings and Fibromyalgia Symptoms
Pain rating after treatment
|
3.2 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Assays for Norepinephrine and Serotonin were not performed.
The investigators will measure cerebrospinal fluid and plasma concentrations of serotonin and norepinephrine in CSF and plasma before and after twelve (12) weeks of treatment with milnacipran. Assays for these outcomes were not performed.
Outcome measures
Outcome data not reported
Adverse Events
Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=8 participants at risk
Titrated Milnacipram doses
Milnacipram: Titration to 200mg PO daily
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • Adverse events were collected over the duration of the study (12 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place