Trial Outcomes & Findings for Study of Gralise to Treat Fibromyalgia Patients (NCT NCT02052414)
NCT ID: NCT02052414
Last Updated: 2016-10-19
Results Overview
Fibromyalgia pain experienced by study subjects will be captured using NPRS at baseline visit, at each follow visits that are scheduled to occur every 4 weeks over 12 weeks of treatment period, and at the end of treatment visit that will occur 3 weeks after treatment period (12 weeks treatment period + 3 weeks = 15 weeks). Any difference in NPRS scores between baseline and any subsequent visits will indicate the magnitude of pain relief as reflected in digital scale of 0-10 (0=no pain, 10=worst pain imaginable).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
15 weeks
Results posted on
2016-10-19
Participant Flow
Participant milestones
| Measure |
Gralise (Gabapentin ER)
An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.
All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.
Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.
Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Gralise (Gabapentin ER)
An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.
All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.
Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.
Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any.
|
|---|---|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Study of Gralise to Treat Fibromyalgia Patients
Baseline characteristics by cohort
| Measure |
Gralise (Gabapentin ER)
n=34 Participants
This is an open label trial to evaluate the efficacy of Gralise against fibromyalgia pain. If subject is taking gabapentinoids at the time of enrollment, subjects will be required to wash off the medication; otherwise they can start the starter pack for Gralise, and will eventually up titrated to treatment dose of 1800mg with evening meals per day.
Subjects will be followed every 4 weeks for total of 12 weeks. At the end of 12 weeks, subjects will be wash off the Gralise over 2 weeks, and will have a final end of treatment visit at week 15.
Subjects will be asked to rate their pain on numeric pain rating system (NPRS) as primary outcome measure. Subjects will be asked to assess Fibromyalgia Impact Questionnaire (FIQ), Medical Outcome Study (MOS) Sleep questionnaire, and Patient Global Impression of Change (PGIC) as secondary outcome measures.
At each follow up visits, occurrence of adverse events, and changes to concomitant medications were evaluated and recorded.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
55.25 years
STANDARD_DEVIATION 10.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
|
Age of Fibromyalgia Diagnosis
|
6.96 years
n=5 Participants
|
|
Number of active medications
|
1.3 medications
n=5 Participants
|
|
Number of past medications
|
1.6 medications
n=5 Participants
|
|
Number of co-morbid conditions
|
5.3 co-morbid conditions present
n=5 Participants
|
|
Gabapentinoid (Gabapentin/ pregabalin) Naive
Gabapentinoid Naive
|
8 participants
n=5 Participants
|
|
Gabapentinoid (Gabapentin/ pregabalin) Naive
Non-Gabapentinoid naive
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 weeksPopulation: All subjects had diagnosis of fibromyalgia and met the inclusion and exclusion criteria.
Fibromyalgia pain experienced by study subjects will be captured using NPRS at baseline visit, at each follow visits that are scheduled to occur every 4 weeks over 12 weeks of treatment period, and at the end of treatment visit that will occur 3 weeks after treatment period (12 weeks treatment period + 3 weeks = 15 weeks). Any difference in NPRS scores between baseline and any subsequent visits will indicate the magnitude of pain relief as reflected in digital scale of 0-10 (0=no pain, 10=worst pain imaginable).
Outcome measures
| Measure |
Gralise (Gabapentin ER)
n=31 Participants
An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.
All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.
Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.
Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any.
|
|---|---|
|
Numeric Pain Rating System (NPRS)
NPRS Baseline (Visit 1)
|
7.29 units on a scale
Standard Deviation 1.51
|
|
Numeric Pain Rating System (NPRS)
NPRS on Week 4 (Visit 2)
|
4.72 units on a scale
Standard Deviation 2.44
|
|
Numeric Pain Rating System (NPRS)
NPRS on week 8 (Visit 3)
|
3.95 units on a scale
Standard Deviation 2.18
|
|
Numeric Pain Rating System (NPRS)
NPRS on Week 12 (Visit 4)
|
3.83 units on a scale
Standard Deviation 2.05
|
|
Numeric Pain Rating System (NPRS)
NPRS on week 15 (Visit 5)
|
6.94 units on a scale
Standard Deviation 2.08
|
SECONDARY outcome
Timeframe: 15 weeksMedical Outcomes Study (MOS) sleep questionnaires to assess how Fibromyalgia impacts patients' sleep in various areas. Specifically, Data reported below measured number of hours subjects spent per night sleeping. MOS sleep questionnaires were assessed at each follow up visits. (visits 1, 2, 3, 4, and 5).
Outcome measures
| Measure |
Gralise (Gabapentin ER)
n=31 Participants
An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.
All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.
Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.
Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any.
|
|---|---|
|
Medical Outcome Study (MOS) Sleep Questionnaires
Sleep quantity week 15
|
6.23 Hours
Standard Error 1.71
|
|
Medical Outcome Study (MOS) Sleep Questionnaires
Sleep Quantity Baseline
|
5.86 Hours
Standard Error 1.65
|
|
Medical Outcome Study (MOS) Sleep Questionnaires
Sleep Quantity week 4
|
7.17 Hours
Standard Error 1.62
|
|
Medical Outcome Study (MOS) Sleep Questionnaires
Sleep quantity week 8
|
6.81 Hours
Standard Error 1.81
|
|
Medical Outcome Study (MOS) Sleep Questionnaires
Sleep quantity week 12
|
7.04 Hours
Standard Error 0.72
|
SECONDARY outcome
Timeframe: 15 WeeksPopulation: Subject who experienced pain, acute delirium, symptoms related to adhesions due to prior surgical procedures, extremity swelling, and possible drug interactions discontinued medications. Other reported side effects dissipated after subjects reached therapeutic dose of 1800mg of study medication taken at bedtime.
Side / adverse effects were assessed at each follow up visits and resulted are as follows.
Outcome measures
| Measure |
Gralise (Gabapentin ER)
n=31 Participants
An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.
All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.
Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.
Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any.
|
|---|---|
|
Self Reported Side Effects.
Extremity Swelling
|
2 participants
|
|
Self Reported Side Effects.
Weight Gain
|
2 participants
|
|
Self Reported Side Effects.
Drowsy
|
8 participants
|
|
Self Reported Side Effects.
Dizzy
|
3 participants
|
|
Self Reported Side Effects.
Irritability
|
3 participants
|
|
Self Reported Side Effects.
Dry Eyes
|
2 participants
|
|
Self Reported Side Effects.
Pain
|
1 participants
|
|
Self Reported Side Effects.
Mood Changes
|
2 participants
|
|
Self Reported Side Effects.
Difficulty Concentrating
|
2 participants
|
|
Self Reported Side Effects.
Dry Mouth
|
1 participants
|
|
Self Reported Side Effects.
Suspected Drug interaction
|
1 participants
|
|
Self Reported Side Effects.
Acute Delerium
|
1 participants
|
|
Self Reported Side Effects.
Adhesion
|
1 participants
|
|
Self Reported Side Effects.
None
|
12 participants
|
SECONDARY outcome
Timeframe: 15 weeks.Population: FM patients who took study medication.
The Fibromyalgia Impact Questionnaire (FIQ) is an instrument designed to quantitate the overall impact of fibromyalgia over many dimensions (e.g. function, pain level, fatigue, sleep disturbance, psychological distress etc.). It is scored from 0 to 100 with the latter number being the worst case. The average score for patients seen in tertiary care settings is about 50. The FIQ is widely used to assess change in fibromyalgia status.
Outcome measures
| Measure |
Gralise (Gabapentin ER)
n=31 Participants
An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.
All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.
Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.
Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any.
|
|---|---|
|
Fibromyalgia Impact Questionnaire (FIQ)
FIQ Week 4
|
41.82 units on a scale
Standard Deviation 19.57
|
|
Fibromyalgia Impact Questionnaire (FIQ)
FIQ Baseline
|
71.04 units on a scale
Standard Deviation 12.84
|
|
Fibromyalgia Impact Questionnaire (FIQ)
FIQ Week 8
|
40.79 units on a scale
Standard Deviation 20.41
|
|
Fibromyalgia Impact Questionnaire (FIQ)
FIQ Week 12
|
39.27 units on a scale
Standard Deviation 21.37
|
|
Fibromyalgia Impact Questionnaire (FIQ)
FIQ Week 15
|
61.86 units on a scale
Standard Deviation 18.67
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 Weeks.Patient Global impression of Change (PGIC) is an outcome commonly used measure of the efficacy of treatments. PGIC is a 7 point scale that requires the subjects to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Outcome measures
| Measure |
Gralise (Gabapentin ER)
n=31 Participants
An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.
All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.
Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.
Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any.
|
|---|---|
|
Patient Global Impression of Change (PGIC)
PGIC After 4 weeks
|
4.96 units on a scale
Standard Deviation 1.61
|
|
Patient Global Impression of Change (PGIC)
PGIC After 8 weeks
|
5.40 units on a scale
Standard Deviation 1.31
|
|
Patient Global Impression of Change (PGIC)
PGIC After 12 weeks
|
5.37 units on a scale
Standard Deviation 1.54
|
|
Patient Global Impression of Change (PGIC)
PGIC After 15 weeks
|
4.44 units on a scale
Standard Deviation 1.97
|
Adverse Events
Gralise (Gabapentin ER)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gralise (Gabapentin ER)
n=31 participants at risk
An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.
All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.
Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.
Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any.
|
|---|---|
|
Gastrointestinal disorders
Small bowel adhesion
|
3.2%
1/31 • Number of events 1 • Adverse events data were collected at baseline (visit 1), week 4 (visit 2), week 8 (visit 3), week 12 (visit 4), and week 15 (visit 5). If subject required unscheduled visit, AE were collected as part of the visit procedure.
|
|
Nervous system disorders
Acute Delirium
|
3.2%
1/31 • Number of events 1 • Adverse events data were collected at baseline (visit 1), week 4 (visit 2), week 8 (visit 3), week 12 (visit 4), and week 15 (visit 5). If subject required unscheduled visit, AE were collected as part of the visit procedure.
|
Other adverse events
| Measure |
Gralise (Gabapentin ER)
n=31 participants at risk
An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.
All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.
Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.
Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any.
|
|---|---|
|
Metabolism and nutrition disorders
Extremity swelling
|
6.5%
2/31 • Number of events 2 • Adverse events data were collected at baseline (visit 1), week 4 (visit 2), week 8 (visit 3), week 12 (visit 4), and week 15 (visit 5). If subject required unscheduled visit, AE were collected as part of the visit procedure.
|
|
Metabolism and nutrition disorders
Weight Gain
|
6.5%
2/31 • Number of events 2 • Adverse events data were collected at baseline (visit 1), week 4 (visit 2), week 8 (visit 3), week 12 (visit 4), and week 15 (visit 5). If subject required unscheduled visit, AE were collected as part of the visit procedure.
|
|
Nervous system disorders
Drowsiness
|
25.8%
8/31 • Number of events 8 • Adverse events data were collected at baseline (visit 1), week 4 (visit 2), week 8 (visit 3), week 12 (visit 4), and week 15 (visit 5). If subject required unscheduled visit, AE were collected as part of the visit procedure.
|
|
Ear and labyrinth disorders
Dizzines
|
9.7%
3/31 • Number of events 3 • Adverse events data were collected at baseline (visit 1), week 4 (visit 2), week 8 (visit 3), week 12 (visit 4), and week 15 (visit 5). If subject required unscheduled visit, AE were collected as part of the visit procedure.
|
|
Psychiatric disorders
irritability
|
9.7%
3/31 • Number of events 3 • Adverse events data were collected at baseline (visit 1), week 4 (visit 2), week 8 (visit 3), week 12 (visit 4), and week 15 (visit 5). If subject required unscheduled visit, AE were collected as part of the visit procedure.
|
|
Eye disorders
dry eyes
|
6.5%
2/31 • Number of events 2 • Adverse events data were collected at baseline (visit 1), week 4 (visit 2), week 8 (visit 3), week 12 (visit 4), and week 15 (visit 5). If subject required unscheduled visit, AE were collected as part of the visit procedure.
|
|
Musculoskeletal and connective tissue disorders
pain
|
3.2%
1/31 • Number of events 1 • Adverse events data were collected at baseline (visit 1), week 4 (visit 2), week 8 (visit 3), week 12 (visit 4), and week 15 (visit 5). If subject required unscheduled visit, AE were collected as part of the visit procedure.
|
|
Psychiatric disorders
Mood changes
|
6.5%
2/31 • Number of events 2 • Adverse events data were collected at baseline (visit 1), week 4 (visit 2), week 8 (visit 3), week 12 (visit 4), and week 15 (visit 5). If subject required unscheduled visit, AE were collected as part of the visit procedure.
|
|
Nervous system disorders
Difficulty Concentrating
|
6.5%
2/31 • Number of events 2 • Adverse events data were collected at baseline (visit 1), week 4 (visit 2), week 8 (visit 3), week 12 (visit 4), and week 15 (visit 5). If subject required unscheduled visit, AE were collected as part of the visit procedure.
|
|
Gastrointestinal disorders
drymouth
|
3.2%
1/31 • Number of events 1 • Adverse events data were collected at baseline (visit 1), week 4 (visit 2), week 8 (visit 3), week 12 (visit 4), and week 15 (visit 5). If subject required unscheduled visit, AE were collected as part of the visit procedure.
|
|
Metabolism and nutrition disorders
drug interaction
|
3.2%
1/31 • Number of events 1 • Adverse events data were collected at baseline (visit 1), week 4 (visit 2), week 8 (visit 3), week 12 (visit 4), and week 15 (visit 5). If subject required unscheduled visit, AE were collected as part of the visit procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place