Trial Outcomes & Findings for Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia (NCT NCT01331109)
NCT ID: NCT01331109
Last Updated: 2013-09-30
Results Overview
Number of Patients who experience one or more treatment emergent adverse event (TEAE)
TERMINATED
PHASE2
57 participants
Baseline (Visit 1) to Week 53 (Visit 9)
2013-09-30
Participant Flow
Participant milestones
| Measure |
Milnacipran
oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
57
|
Reasons for withdrawal
| Measure |
Milnacipran
oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
38
|
Baseline Characteristics
Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Baseline characteristics by cohort
| Measure |
Milnacipran
n=57 Participants
oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
|
|---|---|
|
Age Continuous
|
15.4 years
STANDARD_DEVIATION 1.35 • n=5 Participants
|
|
Age, Customized
13 years old
|
5 participants
n=5 Participants
|
|
Age, Customized
14 years old
|
12 participants
n=5 Participants
|
|
Age, Customized
15 years old
|
11 participants
n=5 Participants
|
|
Age, Customized
16 years old
|
12 participants
n=5 Participants
|
|
Age, Customized
17 years old
|
17 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=5 Participants
|
|
Maximum Tolerated Dose of Milnacipran
Less than 50mg
|
0 participants
n=5 Participants
|
|
Maximum Tolerated Dose of Milnacipran
50 mg
|
3 participants
n=5 Participants
|
|
Maximum Tolerated Dose of Milnacipran
75 mg
|
8 participants
n=5 Participants
|
|
Maximum Tolerated Dose of Milnacipran
100mg
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Visit 1) to Week 53 (Visit 9)Population: 57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.
Number of Patients who experience one or more treatment emergent adverse event (TEAE)
Outcome measures
| Measure |
Milnacipran
n=57 Participants
oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
|
|---|---|
|
Adverse Events
|
42 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Visit 1) to Week 53 (Visit 9)Population: 57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.
The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity: * Level 1: Wish to be Dead * Level 2: Non-Specific Active Suicidal Thoughts * Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act * Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan * Level 5: Active Suicidal Ideation with Specific Plan and Intent
Outcome measures
| Measure |
Milnacipran
n=57 Participants
oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
|
|---|---|
|
Number of Patients Who Experienced Level 5 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Visit 1) to Week 53 (Visit 9)Population: 57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.
The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity: * Level 1: Wish to be Dead * Level 2: Non-Specific Active Suicidal Thoughts * Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act * Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan * Level 5: Active Suicidal Ideation with Specific Plan and Intent
Outcome measures
| Measure |
Milnacipran
n=57 Participants
oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
|
|---|---|
|
Number of Patients Who Experienced Level 4 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Visit 1) to Week 53 (Visit 9)Population: 57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.
The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity: * Level 1: Wish to be Dead * Level 2: Non-Specific Active Suicidal Thoughts * Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act * Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan * Level 5: Active Suicidal Ideation with Specific Plan and Intent
Outcome measures
| Measure |
Milnacipran
n=57 Participants
oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
|
|---|---|
|
Number of Patients Who Experienced Level 3 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Visit 1) to Week 53 (Visit 9)Population: 57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.
The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity: * Level 1: Wish to be Dead * Level 2: Non-Specific Active Suicidal Thoughts * Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act * Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan * Level 5: Active Suicidal Ideation with Specific Plan and Intent
Outcome measures
| Measure |
Milnacipran
n=57 Participants
oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
|
|---|---|
|
Number of Patients Who Experienced Level 2 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Visit 1) to Week 53 (Visit 9)Population: 57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.
The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity: * Level 1: Wish to be Dead * Level 2: Non-Specific Active Suicidal Thoughts * Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act * Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan * Level 5: Active Suicidal Ideation with Specific Plan and Intent
Outcome measures
| Measure |
Milnacipran
n=57 Participants
oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
|
|---|---|
|
Number of Patients Who Experienced Level 1 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Visit 1) to Week 53 (Visit 9)Population: 57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.
The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal behaviors as defined by the eC-SSRS are: * Preparatory acts or behavior * Aborted attempt * Interrupted attempt * Actual attempt * Completed suicide attempt
Outcome measures
| Measure |
Milnacipran
n=57 Participants
oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
|
|---|---|
|
Number of Patients Who Experienced Any Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)
|
0 participants
|
Adverse Events
Milnacipran
Serious adverse events
| Measure |
Milnacipran
n=57 participants at risk
oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
|
|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
1.8%
1/57 • Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
|
|
Psychiatric disorders
Suicidal Ideation
|
1.8%
1/57 • Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
|
Other adverse events
| Measure |
Milnacipran
n=57 participants at risk
oral administration, twice daily dosing
Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
17.5%
10/57 • Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.5%
6/57 • Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
|
|
Cardiac disorders
Tachycardia
|
10.5%
6/57 • Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
|
|
Infections and infestations
Urinary tract infection
|
8.8%
5/57 • Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
|
|
Gastrointestinal disorders
Vomiting
|
8.8%
5/57 • Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
4/57 • Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
|
|
Nervous system disorders
Headache
|
7.0%
4/57 • Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
|
|
Investigations
Heart rate increased
|
7.0%
4/57 • Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
|
|
Nervous system disorders
Dizziness
|
5.3%
3/57 • Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
|
|
Investigations
Hepatic enzyme increased
|
5.3%
3/57 • Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
3/57 • Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
|
|
Investigations
Weight decreased
|
5.3%
3/57 • Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
|
|
Investigations
Weight increased
|
5.3%
3/57 • Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
- Publication restrictions are in place
Restriction type: OTHER