Last updated: 02/26/2020 19:40:08

To investigate the effects of Ropinirole on the spinal flexor reflex in patients with restless legs syndrome and in healthy volunteers.

GSK study ID
999910/188
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: To investigate the effects of Ropinirole on the spinal flexor reflex in patients with restless legs syndrome and in healthy volunteers.
Trial description: D2 dopaminergic receptors may be involved in abnormal spinal reflex activity underlying Restless Legs Syndrome (RLS). To investigate this hypothesis the effects of ropinirole on the excitability of the spinal flexor reflex (FR) were evaluated, as well as the differences in endogenous D2 –activity in RLS subjects compared with normal controls. In addition ropinirole also has D3 and D4 agonist activity. To evaluate the degree to which non D2 agonist activity contributes to modulation of FR control and RLS manifestation, the study also examined the effects of a single dose of metoclopramide (a selective D2 antagonist) on the pharmacodynamic actions of ropinirole.
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:
Not applicable
Medical condition
Restless Legs Syndrome
Product
ropinirole
Collaborators
Not applicable
Study date(s)
May 2003 to June 2005
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 80 Years
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

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-16-06

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

Additional information
Not applicable
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