Fibromyalgia
Conditions
Brief summary
The main purpose of this study is to evaluate the long-term safety of pregabalin in adolescent patients who participated in the previous fibromyalgia study (A0081180) and who wish to recieve open-label pregabalin
Interventions
DRUGpregabalin
Oral capsule 75-450 mg/day
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions.
Exclusion criteria
* Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia study A0081180 which was determined to be related to the study medication by the investigator or sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Numeric Rating Scale by Week | Baseline, Weeks 3, 8, 16, 24 and Last Visit. | 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. |
Countries
Czechia, India, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Insufficient clinical response | 3 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other reasons | 3 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Pregabalin |
|---|---|
| Age, Continuous | 14.8 Years STANDARD_DEVIATION 1.4 |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 32 / 63 |
| serious Total, serious adverse events | 3 / 63 |
Outcome results
Primary
Change From Baseline in Pain Numeric Rating Scale by Week
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Pain Numeric Rating Scale by Week | Baseline (N=63) | 6.7 Number | Standard Deviation 1.68 |
| Pregabalin | Change From Baseline in Pain Numeric Rating Scale by Week | Week 3 (N=61) | -2.1 Number | Standard Deviation 2.51 |
| Pregabalin | Change From Baseline in Pain Numeric Rating Scale by Week | Week 8 (N=55) | -1.8 Number | Standard Deviation 2.95 |
| Pregabalin | Change From Baseline in Pain Numeric Rating Scale by Week | Week 16 (N=51) | -2.1 Number | Standard Deviation 2.6 |
| Pregabalin | Change From Baseline in Pain Numeric Rating Scale by Week | Week 24 (N=55) | -2.1 Number | Standard Deviation 2.56 |
| Pregabalin | Change From Baseline in Pain Numeric Rating Scale by Week | Last Visit (N=63) | -2.1 Number | Standard Deviation 2.47 |