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Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

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ClinicalTrials.gov Identifier: NCT03038308
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : September 2, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Gabrielle Page-Wilson, Columbia University

Tracking Information
First Submitted Date  ICMJE January 30, 2017
First Posted Date  ICMJE January 31, 2017
Last Update Posted Date September 2, 2019
Actual Study Start Date  ICMJE September 16, 2016
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
Prolactin concentrations [ Time Frame: 6-12 months ]
Serum prolactin concentrations
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03038308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
Tumor size [ Time Frame: 6-12 months ]
Radiologic assessment of tumor size before and after treatment will be made by MRI.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole
Official Title  ICMJE Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole: A Dose Escalation Study of Efficacy and Tolerability
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Masking Description:
Open-label studies
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperprolactinemia
  • Prolactinoma
Intervention  ICMJE Drug: Ropinirole
Study Arms  ICMJE Experimental: Drug
Intervention: Drug: Ropinirole
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2017)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gabrielle Page-Wilson, M.D. 212-305-3725 gp2287@cumc.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03038308
Other Study ID Numbers  ICMJE AAAI8604
1R21DK112093-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Gabrielle Page-Wilson, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Gabrielle Page-Wilson, M.D. Columbia University
PRS Account Columbia University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP