Trial Outcomes & Findings for Pregabalin In Adolescent Patients With Fibromyalgia (NCT NCT01020526)
NCT ID: NCT01020526
Last Updated: 2021-01-28
Results Overview
The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
63 participants
Primary outcome timeframe
Baseline, Weeks 3, 8, 16, 24 and Last Visit.
Results posted on
2021-01-28
Participant Flow
A total of 63 participants were screened and enrolled at 19 study centers in this open-label extension study to the parent double-blind randomized fibromyalgia study A0081180.
Participant milestones
| Measure |
Pregabalin
Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
|
|---|---|
|
Overall Study
STARTED
|
63
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Pregabalin
Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Other reasons
|
3
|
|
Overall Study
Insufficient clinical response
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Pregabalin In Adolescent Patients With Fibromyalgia
Baseline characteristics by cohort
| Measure |
Pregabalin
n=63 Participants
Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
|
|---|---|
|
Age, Continuous
|
14.8 Years
STANDARD_DEVIATION 1.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 3, 8, 16, 24 and Last Visit.Population: This population will include all participants who have received at least one dose of study medication.
The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement.
Outcome measures
| Measure |
Pregabalin
n=63 Participants
Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
|
|---|---|
|
Change From Baseline in Pain Numeric Rating Scale by Week
Baseline (N=63)
|
6.7 Number
Standard Deviation 1.68
|
|
Change From Baseline in Pain Numeric Rating Scale by Week
Week 3 (N=61)
|
-2.1 Number
Standard Deviation 2.51
|
|
Change From Baseline in Pain Numeric Rating Scale by Week
Week 8 (N=55)
|
-1.8 Number
Standard Deviation 2.95
|
|
Change From Baseline in Pain Numeric Rating Scale by Week
Week 16 (N=51)
|
-2.1 Number
Standard Deviation 2.6
|
|
Change From Baseline in Pain Numeric Rating Scale by Week
Week 24 (N=55)
|
-2.1 Number
Standard Deviation 2.56
|
|
Change From Baseline in Pain Numeric Rating Scale by Week
Last Visit (N=63)
|
-2.1 Number
Standard Deviation 2.47
|
Adverse Events
Pregabalin
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
n=63 participants at risk
Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
|
|---|---|
|
Infections and infestations
Appendicitis
|
1.6%
1/63 • Adverse Events were recorded from the time the participants had taken at least one dose of study drug through the last subject visit.
For summary purposes, adverse event investigator terms were converted to preferred terms using a standard system of classification (COSTART or MedDRA). Adverse events tabulations included summaries by body system or system organ class, by overall decreasing frequency and by maximum intensity.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
1.6%
1/63 • Adverse Events were recorded from the time the participants had taken at least one dose of study drug through the last subject visit.
For summary purposes, adverse event investigator terms were converted to preferred terms using a standard system of classification (COSTART or MedDRA). Adverse events tabulations included summaries by body system or system organ class, by overall decreasing frequency and by maximum intensity.
|
|
Nervous system disorders
Migraine
|
1.6%
1/63 • Adverse Events were recorded from the time the participants had taken at least one dose of study drug through the last subject visit.
For summary purposes, adverse event investigator terms were converted to preferred terms using a standard system of classification (COSTART or MedDRA). Adverse events tabulations included summaries by body system or system organ class, by overall decreasing frequency and by maximum intensity.
|
Other adverse events
| Measure |
Pregabalin
n=63 participants at risk
Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.9%
5/63 • Adverse Events were recorded from the time the participants had taken at least one dose of study drug through the last subject visit.
For summary purposes, adverse event investigator terms were converted to preferred terms using a standard system of classification (COSTART or MedDRA). Adverse events tabulations included summaries by body system or system organ class, by overall decreasing frequency and by maximum intensity.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.9%
5/63 • Adverse Events were recorded from the time the participants had taken at least one dose of study drug through the last subject visit.
For summary purposes, adverse event investigator terms were converted to preferred terms using a standard system of classification (COSTART or MedDRA). Adverse events tabulations included summaries by body system or system organ class, by overall decreasing frequency and by maximum intensity.
|
|
Gastrointestinal disorders
Nausea
|
7.9%
5/63 • Adverse Events were recorded from the time the participants had taken at least one dose of study drug through the last subject visit.
For summary purposes, adverse event investigator terms were converted to preferred terms using a standard system of classification (COSTART or MedDRA). Adverse events tabulations included summaries by body system or system organ class, by overall decreasing frequency and by maximum intensity.
|
|
Infections and infestations
Ear infection
|
6.3%
4/63 • Adverse Events were recorded from the time the participants had taken at least one dose of study drug through the last subject visit.
For summary purposes, adverse event investigator terms were converted to preferred terms using a standard system of classification (COSTART or MedDRA). Adverse events tabulations included summaries by body system or system organ class, by overall decreasing frequency and by maximum intensity.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.3%
4/63 • Adverse Events were recorded from the time the participants had taken at least one dose of study drug through the last subject visit.
For summary purposes, adverse event investigator terms were converted to preferred terms using a standard system of classification (COSTART or MedDRA). Adverse events tabulations included summaries by body system or system organ class, by overall decreasing frequency and by maximum intensity.
|
|
Nervous system disorders
Dizziness
|
22.2%
14/63 • Adverse Events were recorded from the time the participants had taken at least one dose of study drug through the last subject visit.
For summary purposes, adverse event investigator terms were converted to preferred terms using a standard system of classification (COSTART or MedDRA). Adverse events tabulations included summaries by body system or system organ class, by overall decreasing frequency and by maximum intensity.
|
|
Nervous system disorders
Headache
|
9.5%
6/63 • Adverse Events were recorded from the time the participants had taken at least one dose of study drug through the last subject visit.
For summary purposes, adverse event investigator terms were converted to preferred terms using a standard system of classification (COSTART or MedDRA). Adverse events tabulations included summaries by body system or system organ class, by overall decreasing frequency and by maximum intensity.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.7%
3/53 • Adverse Events were recorded from the time the participants had taken at least one dose of study drug through the last subject visit.
For summary purposes, adverse event investigator terms were converted to preferred terms using a standard system of classification (COSTART or MedDRA). Adverse events tabulations included summaries by body system or system organ class, by overall decreasing frequency and by maximum intensity.
|
|
General disorders
Fatigue
|
12.7%
8/63 • Adverse Events were recorded from the time the participants had taken at least one dose of study drug through the last subject visit.
For summary purposes, adverse event investigator terms were converted to preferred terms using a standard system of classification (COSTART or MedDRA). Adverse events tabulations included summaries by body system or system organ class, by overall decreasing frequency and by maximum intensity.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.3%
4/63 • Adverse Events were recorded from the time the participants had taken at least one dose of study drug through the last subject visit.
For summary purposes, adverse event investigator terms were converted to preferred terms using a standard system of classification (COSTART or MedDRA). Adverse events tabulations included summaries by body system or system organ class, by overall decreasing frequency and by maximum intensity.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study participating sites. Investigator may not disclose previously undisclosed confidential other than study results.
- Publication restrictions are in place
Restriction type: OTHER