A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease (TANDEM-662)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01485172
First received: December 1, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

This study is a fixed dose, dose response study to characterize the dose response for ropinirole PR in early stage PD patients (Hoehn & Yahr stages I-III). After screening and baseline assessments, subjects will be randomized to one of six final target treatment groups (placebo, 2, 4, 8, 12 or 24mg/day ropinirole PR). The study will consist of a screening period, an up-titration period, a maintenance period, a down titration period and a follow up period. This study utilizes change from baseline in the UPDRS motor score as the primary endpoint, in line with that used in the ropinirole PR monotherapy pivotal study (SK&F101468/168). Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.


Condition Intervention Phase
Parkinson Disease
Drug: ropinirole monotherapy
Drug: placebo monotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release (PR) in Patients With Early Stage Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in UPDRS Motor Score from Baseline [ Time Frame: Week 4 of the maintenance period ] [ Designated as safety issue: No ]
    The Unified Parkinson Disease Rating Scale (UPDRS) is a clinician based rating scale used to measure motor impairments and disability.


Estimated Enrollment: 182
Study Start Date: May 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ropinirole
ropinirole 2, 4, 8, 12, or 24 mg/day
Drug: ropinirole monotherapy
ropinirole as monotherapy in Parkinson's disease
Placebo Comparator: placebo
placebo comparator 2, 4, 8, 12, or 24 mg/day
Drug: ropinirole monotherapy
ropinirole as monotherapy in Parkinson's disease
Drug: placebo monotherapy
placebo as monotherapy in Parkinson's disease

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of idiopathic Parkinson's disease (according to modified Hoehn & Yahr criteria Stages I-III.)
  • Subjects aged 30 years or greater at screening. Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for at least one month prior to randomization and one month following completion of the study. Acceptable contraceptive methods include abstinence, oral contraception, injectable progestogen, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, surgical sterilisation, male partner sterilization, intrauterine device [IUD], or double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository.
  • A baseline UPDRS motor score of at least 10.
  • Limited prior exposure to low or moderate doses of L-DOPA (up to 3 months in total) or dopamine agonists including ropinirole (up to 6 months in total) is allowed provided treatment is discontinued for a minimum of 4 weeks prior to screening.
  • Provide written informed consent for this study.
  • Be willing and able to comply with study procedures.

Exclusion Criteria:

  • Subjects with Parkinson's disease in whom dopaminergic therapy is not warranted at the time of screening.
  • Subjects with severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the investigator, render the subject unsuitable for the study (e.g., psychiatric, haematological, renal, hepatic, endocrinology, neurological [other than Parkinson's disease], cardiovascular, or active malignancy [other than basal cell carcinoma]).
  • Subjects with crippling degenerative arthritis or other physical or mental conditions precluding accurate assessment of efficacy or safety.
  • Subjects with prior or current major psychosis (e.g., schizophrenia or psychotic depression) e.g. scoring 3 or 4 on UPDRS item 2 [thought disorder] or item 3 [depression].
  • Subjects with severe clinical dementia e.g. scoring 3 or 4 on UPDRS item 1 [mentation].
  • Subjects with severe dizziness or fainting due to postural hypotension on standing.
  • Subjects with a personal history of melanoma.
  • Subjects with clinically significant abnormalities in laboratory or ECG tests at Screening. If findings are outside the normal range and the subject is included, it must be documented by the investigator that the findings are not of clinical significance.
  • Subjects diagnosed with an impulse control disorder. The modified MIDI will be conducted at screening. Subjects who score positive for this screen must be referred to a specialist for diagnostic evaluation prior to enrolling (screening) in the study.
  • Subjects with an active suicidal plan/intent or have had active suicidal thoughts in the past 6 months. Subjects with a history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt.
  • Current alcohol or drug dependence.
  • Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure) that would preclude long-term dosing with ropinirole.
  • Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to baseline (randomization).
  • Subjects on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to baseline (randomization) through the end of the treatment period. Smokers should maintain normal smoking habit.
  • Women who are pregnant or breast-feeding.
  • Use of an investigational drug from 30 days or 5 half-lives (which ever is longer) prior to baseline (randomization) to the end of the treatment period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485172

Locations
United States, California
GSK Investigational Site
Pasedena, California, United States, 91105
GSK Investigational Site
Reseda, California, United States, 91355
GSK Investigational Site
Torrance, California, United States, 90505
GSK Investigational Site
Ventura, California, United States, 93003
United States, Florida
GSK Investigational Site
Boca Raton, Florida, United States, 33486
GSK Investigational Site
Tampa, Florida, United States, 33612
United States, Georgia
GSK Investigational Site
Augusta, Georgia, United States, 30912
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23249
Estonia
GSK Investigational Site
Tallinn, Estonia, 13419
GSK Investigational Site
Tallinn, Estonia, 10138
GSK Investigational Site
Tartu, Estonia, 51014
Korea, Republic of
GSK Investigational Site
Busan, Korea, Republic of, 602-715
GSK Investigational Site
Donggu Gwangju, Korea, Republic of, 501757
GSK Investigational Site
Seoul, Korea, Republic of, 152-703
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
Poland
GSK Investigational Site
Kazan, Poland, 420012
Russian Federation
GSK Investigational Site
Chelyabinsk, Russian Federation, 454136
GSK Investigational Site
Ekaterinburg, Russian Federation, 620102
GSK Investigational Site
Krasnoyarsk, Russian Federation, 660022
GSK Investigational Site
Kursk, Russian Federation, 305007
GSK Investigational Site
Novosibirsk, Russian Federation, 630091
GSK Investigational Site
Omsk, Russian Federation, 644033
GSK Investigational Site
Perm, Russian Federation, 614990
GSK Investigational Site
Saratov, Russian Federation, 410012
GSK Investigational Site
Smolensk, Russian Federation, 214019
GSK Investigational Site
St.Petersburg, Russian Federation, 194044
GSK Investigational Site
Ufa, Russian Federation, 450000
Slovakia
GSK Investigational Site
Banska Bystrica, Slovakia, 974 04
GSK Investigational Site
Bratislava, Slovakia, 813 69
GSK Investigational Site
Bratislava, Slovakia, 831 03
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01485172     History of Changes
Other Study ID Numbers: 111662
Study First Received: December 1, 2011
Last Updated: April 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014