Clinical trial NCT03038308: Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole
Official title: Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole: A Dose Escalation Study of Efficacy and Tolerability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hyperprolactinemia
Prolactinoma
Keywords: ropinirole
hyperprolactinemia
prolactin
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-01-31
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Ages 18-70 years
* Prolactin level (PRL) ≥2 times upper limit of normal
* Pituitary adenomas on MRI ≤ 1.5cm in greatest diameter and ≥ 5mm from the optic chiasm
* Normal renal and liver function
* Agrees to barrier contraception if pre-menopausal

Exclusion Criteria:

* Use of medications known to interfere with PRL secretion and PRL and Ropinirole (ROP) metabolism
* Use of another dopamine agonist during the 4 weeks prior
* Pituitary stalk compression on MRI
* History of visual field abnormalities or previous radiation
* Untreated hypothyroidism
* Consumption of \> 2 alcoholic drinks per day
* Pregnancy

Primary outcomes:
measure: 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.
timeFrame: 6-12 months
Secondary outcomes:
measure: Number of Subjects With Stable or Decreased Tumor Size
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Gabrielle Page-Wilson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.