Complex Regional Pain Syndrome I (CRPS I)
Conditions
Keywords
CRPS I
Brief summary
The purpose of this study is to see if an FDA-approved drug (Gralise) can help people with certain types of neuropathic pain without causing too many side effects.
Detailed description
This research is being conducted to see if the drug Gralise can help people with Complex Regional Pain Syndrom Type I (CRPS I) without causing too many side effects. CRPS I is one of the most common conditions of neuropathic pain (pain that results from damage to nerves in the peripheral nervous system). Gralise is approved by the U.S. Food and Drug Administration (FDA) to treat postherpetic neuralgia (a complication of the disease Shingles, which is caused by the chickenpox virus), but is not approved to treat CRPS I.
Interventions
DRUGGabapentin
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject will be between 18 to 80 years of age. 2. Subject has not been on Gralise. 3. Subject has not been on gabapentin for at least one month. 4. Subject agrees to make no change in his/her current pain medications during the study period to ensure that comparisons can be made before and after the Gralise treatment. 5. Subject has a VAS pain score of 5 or above at the beginning of the study. 6. Subject has had CRPS I for at least three months to avoid clinical uncertainty and minimize the study variation. 7. Female subjects of childbearing age must have a negative urine pregnancy test at the initial visit.
Exclusion criteria
1. Subject has severe liver or renal disease that will affect the elimination of Gralise. (Renal dysfunction is defined as eGFR \< 60. Hepatic dysfunction is defined as LFTs ≥ 3X ULN.) 2. Subject has pending litigation related to his/her CRPS I condition. 3. Subject is pregnant or lactating. 4. Subject is allergic to gabapentin or Gralise. 5. Subject has a positive urine (illicit) drug test. 6. Subject has any history of suicidal thoughts or behaviors, as self reported or in documented medical history. 7. Subjects with known seizure disorders (except febrile seizures) and/or taking antiepileptic drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) at Visit 3 | At visit 3 | Subjects rated their pain using the VAS at visit 3, which was the last day of their maintenance phase. After this visit, subjects begin to taper the gralise. The VAS is subject reported on a scale of 0-10 with 0 being no pain and 10 being the worst pain they can imagine. Results reported are an average of the 3 subjects who completed visit 3. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CRPS I Pain Subjects This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.
Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | CRPS I Pain Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
| Visual Analog Scale (VAS) | 5.8 units on a scale |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Visual Analog Scale (VAS) at Visit 3
Subjects rated their pain using the VAS at visit 3, which was the last day of their maintenance phase. After this visit, subjects begin to taper the gralise. The VAS is subject reported on a scale of 0-10 with 0 being no pain and 10 being the worst pain they can imagine. Results reported are an average of the 3 subjects who completed visit 3.
Time frame: At visit 3
Population: Only 3 subjects completed visit 3. The other 2 subjects dropped out due to expected side effects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CRPS I Pain Subjects | Visual Analog Scale (VAS) at Visit 3 | 3.67 units on the VAS | Standard Deviation 1.15 |
p-value: >0.05t-test, 2 sided