Trial Outcomes & Findings for Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole (NCT NCT03038308)
NCT ID: NCT03038308
Last Updated: 2024-06-04
Results Overview
Serum prolactin concentrations (PRL levels) were measured in patients at baseline, 2 and 4 weeks after starting therapy and then once monthly thereafter for 24 weeks. Serum prolactin was measured in duplicate by two-site chemiluminescent enzyme immunometric assay using the Immulite 1000 Analyzer (Siemens Healthcare Diagnostics, Deerfield, IL). The reference range for serum prolactin is 1.9-25 ng/ml for adult females.
COMPLETED
PHASE1/PHASE2
16 participants
6-12 months
2024-06-04
Participant Flow
1 Subject was determined to be ineligible after consenting.
Participant milestones
| Measure |
ROP Intervention
Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study
Ropinirole: 0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
ROP Intervention
Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study
Ropinirole: 0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole
|
|---|---|
|
Overall Study
Surgical resection
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole
Baseline characteristics by cohort
| Measure |
ROP Intervention
n=16 Participants
Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study
Ropinirole: 0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=93 Participants
|
|
Prolactin
|
126 ng/mL
STANDARD_DEVIATION 41.4 • n=93 Participants
|
PRIMARY outcome
Timeframe: 6-12 monthsPopulation: Of the 16 subjects enrolled, 1 was deemed ineligible after completion of screening, 2 relocated out of state prior to taking first dose, 1 was withdrawn after week 1 following decision to pursue surgical resection of the prolactinoma. 12 participated longitudinally -- 1 was lost to follow-up after 16 weeks; 11 subjects completed 24 weeks and 5/11 subjects continued ropinirole therapy for one year with 2/11 remaining in protocol for 17 months due pandemic related delays in final visits.
Serum prolactin concentrations (PRL levels) were measured in patients at baseline, 2 and 4 weeks after starting therapy and then once monthly thereafter for 24 weeks. Serum prolactin was measured in duplicate by two-site chemiluminescent enzyme immunometric assay using the Immulite 1000 Analyzer (Siemens Healthcare Diagnostics, Deerfield, IL). The reference range for serum prolactin is 1.9-25 ng/ml for adult females.
Outcome measures
| Measure |
ROP Intervention
n=12 Participants
Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study
Ropinirole: 0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole
|
|---|---|
|
Percentage of Subjects That Achieved PRL Normalization as Defined by a Serum Prolactin Level Less Than 25ng/mL at Any Time Point During the Study Treatment Period.
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Nine participants analyzed as only 9 participants had a followup MRI at 6 months.
Number of subjects with stable or decreased tumor size from baseline assessment to assessment after 6 months of treatment. Radiologic assessment of tumor size before and after treatment will be made by MRI.
Outcome measures
| Measure |
ROP Intervention
n=9 Participants
Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study
Ropinirole: 0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole
|
|---|---|
|
Number of Subjects With Stable or Decreased Tumor Size
|
7 participants
|
Adverse Events
ROP Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ROP Intervention
n=10 participants at risk
Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study
Ropinirole: 0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole
|
|---|---|
|
General disorders
Fatigue
|
60.0%
6/10 • 6 months
|
|
General disorders
Nausea
|
40.0%
4/10 • 6 months
|
|
General disorders
Headache
|
20.0%
2/10 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place