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Trial record 5 of 89 for:    "Neuromuscular Disease" | "Norepinephrine"

Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia (MyFi)

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ClinicalTrials.gov Identifier: NCT01331109
Recruitment Status : Terminated
First Posted : April 7, 2011
Results First Posted : September 30, 2013
Last Update Posted : September 30, 2013
Sponsor:
Collaborator:
Cypress Bioscience, Inc.
Information provided by (Responsible Party):
Forest Laboratories

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Fibromyalgia
Intervention Drug: Milnacipran
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Milnacipran
Hide Arm/Group Description

oral administration, twice daily dosing

Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.

Period Title: Overall Study
Started 57
Completed 0
Not Completed 57
Reason Not Completed
Adverse Event             6
Lack of Efficacy             2
Protocol Violation             3
Withdrawal by Subject             7
Lost to Follow-up             1
Study Terminated by Sponsor             38
Arm/Group Title Milnacipran
Hide Arm/Group Description

oral administration, twice daily dosing

Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.

Overall Number of Baseline Participants 57
Hide Baseline Analysis Population Description
All demographic data was based on the safety population, which consists of 57 patients who took at least 1 dose of open-label milnacipran.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants
15.4  (1.35)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 57 participants
13 years old 5
14 years old 12
15 years old 11
16 years old 12
17 years old 17
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants
Female
50
  87.7%
Male
7
  12.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 57 participants
57
Maximum Tolerated Dose of Milnacipran   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 57 participants
Less than 50mg 0
50 mg 3
75 mg 8
100mg 46
[1]
Measure Description: Maximum tolerated daily dose of milnacipran.
1.Primary Outcome
Title Adverse Events
Hide Description Number of Patients who experience one or more treatment emergent adverse event (TEAE)
Time Frame Baseline (Visit 1) to Week 53 (Visit 9)
Hide Outcome Measure Data
Hide Analysis Population Description
57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.
Arm/Group Title Milnacipran
Hide Arm/Group Description:

oral administration, twice daily dosing

Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.

Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
42
2.Other Pre-specified Outcome
Title Number of Patients Who Experienced Level 5 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
Hide Description

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
Time Frame Baseline (Visit 1) to Week 53 (Visit 9)
Hide Outcome Measure Data
Hide Analysis Population Description
57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.
Arm/Group Title Milnacipran
Hide Arm/Group Description:

oral administration, twice daily dosing

Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.

Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
0
3.Other Pre-specified Outcome
Title Number of Patients Who Experienced Level 4 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
Hide Description

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
Time Frame Baseline (Visit 1) to Week 53 (Visit 9)
Hide Outcome Measure Data
Hide Analysis Population Description
57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.
Arm/Group Title Milnacipran
Hide Arm/Group Description:

oral administration, twice daily dosing

Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.

Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
1
4.Other Pre-specified Outcome
Title Number of Patients Who Experienced Level 3 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
Hide Description

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
Time Frame Baseline (Visit 1) to Week 53 (Visit 9)
Hide Outcome Measure Data
Hide Analysis Population Description
57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.
Arm/Group Title Milnacipran
Hide Arm/Group Description:

oral administration, twice daily dosing

Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.

Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
1
5.Other Pre-specified Outcome
Title Number of Patients Who Experienced Level 2 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
Hide Description

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
Time Frame Baseline (Visit 1) to Week 53 (Visit 9)
Hide Outcome Measure Data
Hide Analysis Population Description
57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.
Arm/Group Title Milnacipran
Hide Arm/Group Description:

oral administration, twice daily dosing

Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.

Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
0
6.Other Pre-specified Outcome
Title Number of Patients Who Experienced Level 1 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
Hide Description

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
Time Frame Baseline (Visit 1) to Week 53 (Visit 9)
Hide Outcome Measure Data
Hide Analysis Population Description
57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.
Arm/Group Title Milnacipran
Hide Arm/Group Description:

oral administration, twice daily dosing

Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.

Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
3
7.Other Pre-specified Outcome
Title Number of Patients Who Experienced Any Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)
Hide Description

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
Time Frame Baseline (Visit 1) to Week 53 (Visit 9)
Hide Outcome Measure Data
Hide Analysis Population Description
57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.
Arm/Group Title Milnacipran
Hide Arm/Group Description:

oral administration, twice daily dosing

Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.

Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
0
Time Frame Adverse Event data was collected during a 14-month period from July, 2011 to August, 2012.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Milnacipran
Hide Arm/Group Description

oral administration, twice daily dosing

Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.

All-Cause Mortality
Milnacipran
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Milnacipran
Affected / at Risk (%)
Total   2/57 (3.51%) 
Hepatobiliary disorders   
Cholecystitis  1  1/57 (1.75%) 
Psychiatric disorders   
Suicidal Ideation  1  1/57 (1.75%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedRDA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Milnacipran
Affected / at Risk (%)
Total   28/57 (49.12%) 
Cardiac disorders   
Tachycardia  1  6/57 (10.53%) 
Gastrointestinal disorders   
Nausea  1  10/57 (17.54%) 
Vomiting  1  5/57 (8.77%) 
Abdominal pain  1  4/57 (7.02%) 
Infections and infestations   
Urinary tract infection  1  5/57 (8.77%) 
Investigations   
Heart rate increased  1  4/57 (7.02%) 
Hepatic enzyme increased  1  3/57 (5.26%) 
Weight decreased  1  3/57 (5.26%) 
Weight increased  1  3/57 (5.26%) 
Metabolism and nutrition disorders   
Decreased appetite  1  6/57 (10.53%) 
Nervous system disorders   
Headache  1  4/57 (7.02%) 
Dizziness  1  3/57 (5.26%) 
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain  1  3/57 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedRDA 15.0
This study was terminated early, resulting in a small number of patients analyzed. Only descriptive statistics were presented.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Palmer, MD
Organization: Forest Research Institute
Phone: 1-201-427-8200 ext 8218
EMail: robert.palmer@frx.com
Layout table for additonal information
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01331109     History of Changes
Other Study ID Numbers: MLN-MD-29
First Submitted: March 31, 2011
First Posted: April 7, 2011
Results First Submitted: July 31, 2013
Results First Posted: September 30, 2013
Last Update Posted: September 30, 2013