Trial Outcomes & Findings for Non-Opioid Pramipexole and Pain (NCT NCT03842709)
NCT ID: NCT03842709
Last Updated: 2024-10-23
Results Overview
Change in self-reported effect of pain on quality of life. The "Brief Pain Inventory, Short Form," instrument will be used. It records severity (0-10 scale; 10= worst pain) at its worst.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
13 participants
Primary outcome timeframe
4 weeks
Results posted on
2024-10-23
Participant Flow
Participant milestones
| Measure |
Standard Treatment + Placebo
Patients reporting sub-optimal results of pain therapy, assigned to placebo in addition to routine care.
Placebo: Administration of placebo
|
Standard Treatment + Pramipexole
Patients reporting sub-optimal results of pain therapy, assigned to receive pramipexole in addition to routine care.
Pramipexole Oral Tablet: Initial dosage of 0.125 mg pramipexole daily, potentially titrated upward in 0.125 increments to a maximum of 0.5 mg daily, for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
Initiated Treatment
|
6
|
5
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Standard Treatment + Placebo
Patients reporting sub-optimal results of pain therapy, assigned to placebo in addition to routine care.
Placebo: Administration of placebo
|
Standard Treatment + Pramipexole
Patients reporting sub-optimal results of pain therapy, assigned to receive pramipexole in addition to routine care.
Pramipexole Oral Tablet: Initial dosage of 0.125 mg pramipexole daily, potentially titrated upward in 0.125 increments to a maximum of 0.5 mg daily, for 4 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Treatment + Placebo
n=6 Participants
Patients reporting sub-optimal results of pain therapy, assigned to placebo in addition to routine care.
Placebo: Administration of placebo
|
Standard Treatment + Pramipexole
n=5 Participants
Patients reporting sub-optimal results of pain therapy, assigned to receive pramipexole in addition to routine care.
Pramipexole Oral Tablet: Initial dosage of 0.125 mg pramipexole daily, potentially titrated upward in 0.125 increments to a maximum of 0.5 mg daily, for 4 weeks.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=11 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
5 participants
n=5 Participants
|
11 participants
n=11 Participants
|
|
Pain scores at enrollment
|
7.5 units on a scale
STANDARD_DEVIATION 2.0 • n=6 Participants
|
8.2 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
7.8 units on a scale
STANDARD_DEVIATION 1.8 • n=11 Participants
|
|
Blood cytokine levels at enrollment (IL-1b)
|
7.5 Fold change from baseline
STANDARD_DEVIATION 3.1 • n=6 Participants
|
13.9 Fold change from baseline
STANDARD_DEVIATION 7.5 • n=5 Participants
|
10.7 Fold change from baseline
STANDARD_DEVIATION 6.4 • n=11 Participants
|
PRIMARY outcome
Timeframe: 4 weeksChange in self-reported effect of pain on quality of life. The "Brief Pain Inventory, Short Form," instrument will be used. It records severity (0-10 scale; 10= worst pain) at its worst.
Outcome measures
| Measure |
Standard Treatment + Placebo
n=3 Participants
Patients reporting sub-optimal results of pain therapy, assigned to placebo in addition to routine care.
Placebo: Administration of placebo
|
Standard Treatment + Pramipexole
n=3 Participants
Patients reporting sub-optimal results of pain therapy, assigned to receive pramipexole in addition to routine care.
Pramipexole Oral Tablet: Initial dosage of 0.125 mg pramipexole daily, potentially titrated upward in 0.125 increments to a maximum of 0.5 mg daily, for 4 weeks.
|
|---|---|---|
|
Brief Pain Inventory Score
|
8 score on a scale
Standard Deviation 1
|
6.7 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Four participants did not provide relevant blood samples.
Fold change of the mRNA gene expression from the house keeping gene and the controls.
Outcome measures
| Measure |
Standard Treatment + Placebo
n=4 Participants
Patients reporting sub-optimal results of pain therapy, assigned to placebo in addition to routine care.
Placebo: Administration of placebo
|
Standard Treatment + Pramipexole
n=3 Participants
Patients reporting sub-optimal results of pain therapy, assigned to receive pramipexole in addition to routine care.
Pramipexole Oral Tablet: Initial dosage of 0.125 mg pramipexole daily, potentially titrated upward in 0.125 increments to a maximum of 0.5 mg daily, for 4 weeks.
|
|---|---|---|
|
mRNA Results IL-1b
|
16.1 Fold change
Standard Deviation 8.1
|
8.6 Fold change
Standard Deviation 8.6
|
Adverse Events
Standard Treatment + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Treatment + Pramipexole
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Treatment + Placebo
n=6 participants at risk
Patients reporting sub-optimal results of pain therapy, assigned to placebo in addition to routine care.
Placebo: Administration of placebo
|
Standard Treatment + Pramipexole
n=5 participants at risk
Patients reporting sub-optimal results of pain therapy, assigned to receive pramipexole in addition to routine care.
Pramipexole Oral Tablet: Initial dosage of 0.125 mg pramipexole daily, potentially titrated upward in 0.125 increments to a maximum of 0.5 mg daily, for 4 weeks.
|
|---|---|---|
|
Nervous system disorders
dizziness
|
0.00%
0/6 • 4 weeks
|
20.0%
1/5 • Number of events 1 • 4 weeks
|
Additional Information
ERIN MILLIGAN,
University of New Mexico-Dept of Neurosciences
Phone: 505-272-4411
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place