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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DK112093-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to evaluate the use of the non-ergoline dopamine agonist ropinirole for the treatment of hyperprolactinemia in patients with idiopathic hyperprolactinemia and prolactinomas.
Treatment of prolactin secreting pituitary tumors with traditional ergot dopamine agonist drugs can be limited by medication side effects, pharmacologic resistance, and by concerns regarding the potential risk of cardiac valve disease. The overall goal of this project is therefore to evaluate, for the first time, the efficacy and tolerability of the selective D2/D3 receptor non-ergot dopamine agonist ropinirole for the treatment of prolactinomas. This proposal will establish the pharmacologic profile of this medication when used to treat hyperprolactinemia in patients with prolactinomas and will determine the impact of long-term ropinirole administration on critical clinical parameters including serum prolactin levels, gonadal function, and tumor regression, in order to establish ropinirole's utility as a new, clinically efficacious, safer and more tolerable therapeutic option for the treatment of prolactinomas that may prove particularly useful in patients with underlying cardiac valve disease and in those with resistance or intolerance to ergot dopamine agonists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROP Intervention | Experimental | Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropinirole | Drug | 0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 6-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Stable or Decreased Tumor Size | 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabrielle Page-Wilson, M.D. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30362146 | Background | Liu S, Hu C, Peters J, Tsang A, Cremers S, Bies R, Page-Wilson G. Pharmacokinetics and pharmacodynamics of ropinirole in patients with prolactinomas. Br J Clin Pharmacol. 2019 Feb;85(2):366-376. doi: 10.1111/bcp.13802. Epub 2018 Nov 22. | |
| 37715962 | Derived | Heneghan LJ, Tsang A, Dimino C, Khandji AG, Panigrahi SK, Page-Wilson G. Ropinirole for the Treatment of Hyperprolactinemia: A Dose-Escalation Study of Efficacy and Tolerability. J Clin Endocrinol Metab. 2024 Jan 18;109(2):e667-e674. doi: 10.1210/clinem/dgad545. |
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1 Subject was determined to be ineligible after consenting.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only 15 out of 16 enrolled subjects went on to receive study therapy; however, demographic information was collected for all 16 enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | 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. | Posted | Count of Participants | Participants | 6-12 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabrielle Page-Wilson, MD | Columbia University | 212-305-3725 | gp2287@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2019 | Jul 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006966 | Hyperprolactinemia |
| D015175 | Prolactinoma |
| ID | Term |
|---|---|
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| C046649 | ropinirole |
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1) Forced titration dose response PKPD study and 2) A prospective open-label outpatient dose escalation trial of ropinirole for treatment of prolactinomas and hyperprolactinemia.
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Open-label studies
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Prolactin | Mean | Standard Deviation | ng/mL |
|
| Description |
|---|
| OG000 | 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 |
|
|
| Secondary | Number of Subjects With Stable or Decreased Tumor Size | 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. | Nine participants analyzed as only 9 participants had a followup MRI at 6 months. | Posted | Number | participants | 6 months |
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 8 |
| 10 |
| Nausea | General disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
|
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010911 | Pituitary Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |