Trial Outcomes & Findings for A Study Of Milnacipran In Patients With Fibromyalgia: Effects On 24 Hour Ambulatory Blood Pressure Monitoring (NCT NCT00618956)
NCT ID: NCT00618956
Last Updated: 2009-11-20
Results Overview
Change from baseline to Visit 4 in mean systolic blood pressure (SBP) based on ambulatory blood pressure monitor (ABPM) is defined as the mean SBP value at Visit 4 minus the corresponding mean SBP value at baseline in the same 12-hour period post-AM dose.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
321 participants
Primary outcome timeframe
4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)
Results posted on
2009-11-20
Participant Flow
Recruitment period was from October 15, 2007 to April 16, 2008 at 38 centers in the US.
Following 1-to-4 week washout/single-blind placebo lead-in period, patients were randomized (2:1) to one of the treatment groups, milnacipran or placebo, respectively; and orally treated with study medication for 7-week, double-blind treatment period (Visit 2 to 6), followed by a 2-week single-blind placebo discontinuation period (Visit 6 to 8).
Participant milestones
| Measure |
Placebo
ITT N= 93, OC analyzed n=89
|
Milnacipran
Milnacipran 100 to 200 mg/day tablet, oral administration, BID.
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
210
|
|
Overall Study
COMPLETED
|
86
|
160
|
|
Overall Study
NOT COMPLETED
|
25
|
50
|
Reasons for withdrawal
| Measure |
Placebo
ITT N= 93, OC analyzed n=89
|
Milnacipran
Milnacipran 100 to 200 mg/day tablet, oral administration, BID.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
34
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
did not meet criteria, non-compliance
|
2
|
1
|
Baseline Characteristics
A Study Of Milnacipran In Patients With Fibromyalgia: Effects On 24 Hour Ambulatory Blood Pressure Monitoring
Baseline characteristics by cohort
| Measure |
Placebo
n=111 Participants
|
Milnacipran
n=210 Participants
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
48.9 years
STANDARD_DEVIATION 11.1 • n=93 Participants
|
48.3 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
48.5 years
STANDARD_DEVIATION 11.0 • n=27 Participants
|
|
Age, Customized
< 20 years
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Age, Customized
20-59 years
|
91 participants
n=93 Participants
|
174 participants
n=4 Participants
|
265 participants
n=27 Participants
|
|
Age, Customized
>= 60 years
|
19 participants
n=93 Participants
|
34 participants
n=4 Participants
|
53 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=93 Participants
|
198 Participants
n=4 Participants
|
307 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=93 Participants
|
210 participants
n=4 Participants
|
321 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)Population: The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.
Change from baseline to Visit 4 in mean systolic blood pressure (SBP) based on ambulatory blood pressure monitor (ABPM) is defined as the mean SBP value at Visit 4 minus the corresponding mean SBP value at baseline in the same 12-hour period post-AM dose.
Outcome measures
| Measure |
Placebo
n=89 Participants
Normotensive: ITT N=42, OC analyzed n=39; hypertensive: ITT N=51, OC analyzed n=50
|
Milnacipran
n=176 Participants
Normotensive: ITT N=93, OC analyzed n=92; hypertensive: ITT N=88, OC analyzed n=84
|
|---|---|---|
|
Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4
Change in SBP in Normotensive Patients
|
-0.9 mm Hg
Standard Error 1.0
|
4.0 mm Hg
Standard Error 0.8
|
|
Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4
Change in SBP in Hypertensive Patients
|
0.2 mm Hg
Standard Error 1.1
|
3.7 mm Hg
Standard Error 1.0
|
PRIMARY outcome
Timeframe: 7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)Population: The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach
Change from baseline to Visit 6 in mean systolic blood pressure based on ABPM is defined as the mean SBP value at Visit 6 minus the corresponding mean SBP value at baseline in the same 12-hour period post-AM dose.
Outcome measures
| Measure |
Placebo
n=84 Participants
Normotensive: ITT N=42, OC analyzed n=39; hypertensive: ITT N=51, OC analyzed n=50
|
Milnacipran
n=162 Participants
Normotensive: ITT N=93, OC analyzed n=92; hypertensive: ITT N=88, OC analyzed n=84
|
|---|---|---|
|
Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6
Change in SBP in Normotensive Patients
|
0.1 mm Hg
Standard Error 1.3
|
5.5 mm Hg
Standard Error 0.9
|
|
Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6
Change in SBP in Hypertensive Patients
|
-0.9 mm Hg
Standard Error 1.4
|
4.4 mm Hg
Standard Error 1.0
|
SECONDARY outcome
Timeframe: 4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)Population: The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.
Change from baseline to Visit 4 in mean SBP/DBP based on ABPM is defined as the mean SBP/DBP values at Visit 4 minus the corresponding mean SBP/DBP values at baseline in the same 12-hour period post-AM dose.
Outcome measures
| Measure |
Placebo
n=89 Participants
Normotensive: ITT N=42, OC analyzed n=39; hypertensive: ITT N=51, OC analyzed n=50
|
Milnacipran
n=176 Participants
Normotensive: ITT N=93, OC analyzed n=92; hypertensive: ITT N=88, OC analyzed n=84
|
|---|---|---|
|
Change From Baseline in Mean Systolic Blood Pressure /Diastolic Blood Pressure for 12-hour Period Post-AM Dose at Visit 4
Change in Systolic Blood Pressure
|
-0.3 mm Hg
Standard Error 0.8
|
3.8 mm Hg
Standard Error 0.6
|
|
Change From Baseline in Mean Systolic Blood Pressure /Diastolic Blood Pressure for 12-hour Period Post-AM Dose at Visit 4
Change in Diastolic Blood Pressure
|
-0.3 mm Hg
Standard Error 0.6
|
4.2 mm Hg
Standard Error 0.5
|
SECONDARY outcome
Timeframe: 7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)Population: The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.
Change from baseline to Visit 6 in mean SBP/DBP based on ABPM is defined as the mean SBP/DBP value at Visit 6 minus the corresponding mean SBP/DBP value at baseline in the same 12-hour period post-AM dose.
Outcome measures
| Measure |
Placebo
n=84 Participants
Normotensive: ITT N=42, OC analyzed n=39; hypertensive: ITT N=51, OC analyzed n=50
|
Milnacipran
n=162 Participants
Normotensive: ITT N=93, OC analyzed n=92; hypertensive: ITT N=88, OC analyzed n=84
|
|---|---|---|
|
Change From Baseline in Mean SBP/DBP Following 12-hour Period Post-AM Dose at Visit 6
Change in Diastolic Blood Pressure
|
-0.5 mm Hg
Standard Error 0.7
|
5.0 mm Hg
Standard Error 0.5
|
|
Change From Baseline in Mean SBP/DBP Following 12-hour Period Post-AM Dose at Visit 6
Change in Systolic Blood Pressure
|
-0.4 mm Hg
Standard Error 1.0
|
5.0 mm Hg
Standard Error 0.7
|
SECONDARY outcome
Timeframe: 4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)Population: The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.
Change from baseline to Visit 4 in HR based on ABPM is defined as the mean HR value at Visit 4 minus the corresponding mean HR value at baseline in the same 24-hour period.
Outcome measures
| Measure |
Placebo
n=89 Participants
Normotensive: ITT N=42, OC analyzed n=39; hypertensive: ITT N=51, OC analyzed n=50
|
Milnacipran
n=176 Participants
Normotensive: ITT N=93, OC analyzed n=92; hypertensive: ITT N=88, OC analyzed n=84
|
|---|---|---|
|
Change From Baseline in Mean Heart Rate (HR) Following 24-hour Treatment at Visit 4
Change in Heart Rate
|
-1.0 bpm
Standard Error 0.6
|
11.7 bpm
Standard Error 0.5
|
SECONDARY outcome
Timeframe: 7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)Population: The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.
Change from baseline to Visit 6 in HR based on ABPM is defined as the mean HR value at Visit 6 minus the corresponding mean HR value at baseline in the same 24-hour period.
Outcome measures
| Measure |
Placebo
n=84 Participants
Normotensive: ITT N=42, OC analyzed n=39; hypertensive: ITT N=51, OC analyzed n=50
|
Milnacipran
n=162 Participants
Normotensive: ITT N=93, OC analyzed n=92; hypertensive: ITT N=88, OC analyzed n=84
|
|---|---|---|
|
Change From Baseline in Mean HR Following 24-hour Treatment at Visit 6
Change in Heart Rate
|
-1.6 bpm
Standard Error 0.7
|
12.9 bpm
Standard Error 0.6
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Milnacipran
Serious events: 6 serious events
Other events: 117 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=111 participants at risk
ITT N= 93, OC analyzed n=89
|
Milnacipran
n=210 participants at risk
Milnacipran 100 to 200 mg/day tablet, oral administration, BID.
|
|---|---|---|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/111 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.48%
1/210 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/111 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.48%
1/210 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
0.00%
0/111 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.48%
1/210 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Nervous system disorders
Complicated Migraine
|
0.90%
1/111 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.00%
0/210 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
General disorders
Chest Pain
|
0.00%
0/88 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.61%
1/164 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.00%
0/88 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.61%
1/164 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/88 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.61%
1/164 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/88 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.61%
1/164 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Injury, poisoning and procedural complications
Multiple Injuries
|
0.00%
0/88 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.61%
1/164 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/88 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.61%
1/164 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/88 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.61%
1/164 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Infections and infestations
Periorbital Cellulitis
|
0.00%
0/88 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.61%
1/164 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Gastrointestinal disorders
Peritoneal Haemorrhage
|
0.00%
0/88 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.61%
1/164 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/88 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.61%
1/164 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/88 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.61%
1/164 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/88 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.61%
1/164 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Injury, poisoning and procedural complications
Spelnic Rupture
|
0.00%
0/88 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.61%
1/164 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/88 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.61%
1/164 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/88 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
0.61%
1/164 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
Other adverse events
| Measure |
Placebo
n=111 participants at risk
ITT N= 93, OC analyzed n=89
|
Milnacipran
n=210 participants at risk
Milnacipran 100 to 200 mg/day tablet, oral administration, BID.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
9.9%
11/111 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
22.9%
48/210 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Nervous system disorders
Headache
|
4.5%
5/111 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
13.3%
28/210 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Gastrointestinal disorders
Constipation
|
0.90%
1/111 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
11.0%
23/210 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Cardiac disorders
Tachycardia
|
0.90%
1/111 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
9.5%
20/210 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Nervous system disorders
Dizziness
|
1.8%
2/111 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
7.6%
16/210 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
2/111 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
7.6%
16/210 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Cardiac disorders
Palpitations
|
2.7%
3/111 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
6.7%
14/210 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Vascular disorders
Hot Flush
|
1.8%
2/111 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
6.2%
13/210 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Psychiatric disorders
Insomnia
|
8.1%
9/111 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
5.7%
12/210 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.1%
9/111 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
3.8%
8/210 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Infections and infestations
Urinary Tract Infection
|
6.3%
7/111 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
3.3%
7/210 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
5.4%
6/111 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
3.3%
7/210 • 7 weeks double-blind treatment period followed by 2 weeks single-blind placebo discontinuation period.
For SAEs, 3 of 210 affected in double-blind treatment period \& 3 of 164 affected in single-blind placebo discontinuation period in milnacipran arm; 1 of 111 affected in double-blind treatment period \& 0 of 88 affected in single-blind placebo discontinuation period in placebo arm.
|
Additional Information
Robert Palmer, MD
Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Phone: 201-427-8218
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor can review results communications prior to public release \& can embargo communications re: results for 90 days from time submitted to sponsor for review. PI shall not disclose sponsor's confidential info. Upon sponsor's request, PI shall delete any proprietary info \& shall not include raw data in pub. On sponsor's request, PI shall delay submission for any pub while sponsor files patent apps. If trial is multi-center, PI agrees that first publication shall be a multi-center pub.
- Publication restrictions are in place
Restriction type: OTHER