Last updated: 11/06/2018 23:38:20

A Double-blind, Placebo Controlled, Parallel Group Study of Oral Doses of Ropinirole for Six Months in the Treatment of Early Parkinsonian Patients Not Receiving Dopaminergic Therapy

GSK study ID
101468/054
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Double-blind, Placebo Controlled, Parallel Group Study of Oral Doses of Ropinirole for Six Months in the Treatment of Early Parkinsonian Patients Not Receiving Dopaminergic Therapy
Trial description: A Double-blind, Placebo Controlled, Parallel Group Study of Oral Doses of Ropinirole for Six Months in the Treatment of Early Parkinsonian Patients Not Receiving Dopaminergic Therapy
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Dosing with ropinirole in a clinical setting. Korczyn AD, Rascol O, Adler CH, Warner J. International Congress on Parkinson’s Disease, Vancouver, Canada, Jul 24–28 1999. Parkinsonism Rel Disord 1999; 5(suppl): S77: P-TU-105
Dosing with ropinirole in a clinical setting. Korczyn AD, Thalamas C, Adler CH. Acta Neurol Scand 2002; 106: 200–204
Efficacy and safety of ropinirole as early therapy for Parkinson’s disease. Kreider MS, Wilson-Lynch K, Gardiner D, Wheadon DE. Gerontological Society of America, Washington, USA, Nov 17–21 1996. Gerontologist 1996; 36(special issue 1): 271
Optimal dosing with ropinirole in a clinical setting. Korczyn AD, Rascol O, Adler CH, Warner J. European Federation of Neurological Societies, Lisbon, Portugal, Sep 7–11 1999. Eur J Neurol 1999; 6(suppl 3): 132: P413
Population pharmacokinetics of ropinirole in parkinsonian patients. Beerahee A, Nichols AI, Aluri J, Citerone D, Darwish M. American Society of Health-System Pharmacists, San Francisco, USA, 8–12 Dec 1996. Int Pharmaceutical Abstracts 1996; 33: 21(15 Nov)
Population pharmacokinetics of ropinirole in patients with Parkinson’s disease. Beerahee A, Nichols AI, Aluri J et al. British Pharmacological Society, Brighton, UK, Dec 18–20 1996. Br J Clin Pharmacol 1997; 43: 556–557P
Response of tremor in untreated Parkinson’s disease to therapy with ropinirole. Schrag A, Keens J, Warner J, on behalf of the Ropinirole Study Group. European Federation of Neurological Societies, Lisbon, Portugal, Sep 7–11 1999. Eur J Neurol 1999; 6(suppl 3): 19–20
Resting tremor and postural/action tremor in early Parkinson’s disease (PD): efficacy of ropinirole compared with bromocriptine, l-dopa and placebo. Schrag A, Keens J, Warner J on behalf of the Ropinirole Study Group. Tremor: Basic Mechanisms and Clinical Aspects, Kiel, Germany, Jul 11–12 1997. Abstracts and Consensus Statement, p49 (abstracts)
Ropinirole for the treatment of early Parkinson’s disease. Adler CH, Sethi KD, Hauser RA et al., for the Ropinirole Study Group. Neurology 1997; 49: 393–399
Ropinirole for the treatment of tremor in early Parkinson’s disease. Schrag A, Keens J, Warner J. Eur J Neurol 2002; 9: 253–257
Ropinirole, a non-ergoline D2 agonist, is effective in early parkinsonian patients not treated with l-dopa. Wheadon DE, Wilson-Lynch K, Gardiner D, Kreider MS. International Congress of Movement Disorders, Vienna, Austria, Jun 17–21 1996. Mov Disord 1996; 11(suppl 1): 162: P601
The effect of selegiline on the efficacy and safety of ropinirole in early and adjunct therapy studies in Parkinson’s disease. Fuell DL, Kreider M, Gardiner D. International Symposium on Parkinson’s Disease, London, UK, Mar 23–26 1997. Mov Disord 1997; 12(suppl 1): 116: P437
The efficacy and safety of ropinirole in early parkinsonian patients not receiving dopaminergic therapy: a multicenter double-blind study. Wheadon D, Wilson-Lynch K, Gardiner D, Kreider M. American Academy for Neurology, San Francisco, USA, Mar 23–30 1996. Neurology 1996; 46(suppl 2): A159
The efficacy and safety of ropinirole, a novel non-ergoline selective D2 agonist, for the treatment of early Parkinson’s disease. Brooks DJ, Fuell D, Kreider MS. International Symposium on Parkinson’s Disease, London, UK, Mar 23–26 1997. Mov Disord 1997; 12(suppl 1): 62: P234
Medical condition
Parkinson Disease
Product
ropinirole
Collaborators
Not applicable
Study date(s)
August 1992 to September 1994
Type
Not applicable
Phase
3

Participation criteria

Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Not applicable

Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1994-30-09

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Not applicable
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