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Cerebrovascular AccidentPhase 2NCT00221390

Trial of Ropinirole in Motor Recovery After Stroke

A Phase 2 study testing Ropinirole (+ physical therapy) in people with Cerebrovascular Accident and Hemiparesis, run by University of California, Irvine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess efficacy, as well as safety, of Ropinirole in improving movement among patients with chronic stroke. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cerebrovascular Accident, Hemiparesis
What is being tested?
Ropinirole (+ physical therapy)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
1 siteUnited States
Study dates
Oct 2003to May 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stroke onset 4 weeks-12 months prior
  • Stroke is radiologically confirmed as either (a) ischemic or (b) hemorrhagic
  • Minimum age 18
  • No significant pre-stroke disability
  • No other stroke in previous 3 months
  • Absence of major depression
  • Fugl-Meyer (FM) motor score of 23-83 out of 100
  • Functional Independence Measure (FIM) ambulation-subscore of 3 or more, and 50 foot walk takes longer than 15 seconds

Who cannot join

  • Significant daytime somnolence or any substantial decrease in alertness, language reception, or attention
  • Pregnant or lactating
  • Advanced liver, kidney, cardiac, or pulmonary disease
  • Orthostatic hypotension
  • Current use of ciprofloxacin, a centrally acting dopamine agonist, or a centrally active dopamine antagonist
  • A terminal medical diagnosis consistent with survival < 1 year
Show all 12Show fewer
  • Coexistent major neurological disease
  • Coexistent major psychiatric disease
  • A history of significant alcohol or drug abuse in the prior 3 years
  • A coexistent disease characterized by an abnormality of CNS dopaminergic tone
  • Current enrollment in another investigational study related to stroke or stroke recovery
  • Contraindication to ropinirole prescription

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, Irvine Medical Center

    Orange, California, 92868

Other trials in United States

About this study

Official title: Randomized, Placebo-controlled, Double-blind Pilot Trial to Evaluate the Safety and Efficacy of Ropinirole in Motor Recovery After Stroke

The purpose of this study is to assess efficacy, as well as safety, of Ropinirole in improving movement among patients with chronic stroke.

Read the detailed description

Stroke is a leading cause of disability. Current treatments target injury and must be delivered within hours. A body of literature suggests that there are processes ongoing days-months after stroke that can be targeted therapeutically, and improve function. The current study evaluates one such potential therapy, the dopamine agonist ropinirole. The current study tests the hypothesis that patients with chronic stroke randomized to ropinirole+physiotherapy will show improved gait velocity over the 12 weeks of study participation as compared to patients randomized to placebo+physiotherapy. A secondary aim is to test the hypothesis that ropinirole will improve three secondary endpoints at 12 weeks after study entry: the proportion of patients with no significant disability (Barthel Index ≥ 95); overall motor status, measured with the arm/leg FM score; and overall physical function, defined as the score on the Stroke Impact Scale-16 (SIS-16). This study will also evaluate the safety of ropinirole in patients recovering from stroke.

Being tested
Ropinirole (+ physical therapy), (vs.) Placebo + physical therapy
Keywords
stroke, Chronic stroke with hemiparesis
Medical subject headings
Stroke, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropinirole (+ physical therapy)Drug

  • (vs.) Placebo + physical therapyDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startOct 2003
  3. Primary completionFeb 2007
  4. Study completionMay 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00221390
Sponsor's protocol ID
HS#2003-3096
Status last verified
Oct 2016
First submitted
19 Sep 2005
Last updated
1 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • Gresham GE, Duncan PW, Stason WB, Adams HP, Adelman AM, Alexander DN, Bishop DS, Diller L, Donaldson NE, Granger CV, Holland AL, Kelly-Hayes M, McDowell FH, Myers L, Phipps MA, Roth EJ, Siebens HC, Tarvin GA, Trombly CA. Post-Stroke Rehabilitation. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service, Agency for Health Care Policy and Research, 1995.

  • Rathore SS, Hinn AR, Cooper LS, Tyroler HA, Rosamond WD. Characterization of incident stroke signs and symptoms: findings from the atherosclerosis risk in communities study. Stroke. 2002 Nov;33(11):2718-21. doi: 10.1161/01.str.0000035286.87503.31.

    PubMed 12411667

  • Dobkin BH. Neurologic Rehabilitation. Philadelphia: FA Davis, 1996

  • Nudo RJ. Recovery after damage to motor cortical areas. Curr Opin Neurobiol. 1999 Dec;9(6):740-7. doi: 10.1016/s0959-4388(99)00027-6.

    PubMed 10607636

  • Cramer SC, Chopp M. Recovery recapitulates ontogeny. Trends Neurosci. 2000 Jun;23(6):265-71. doi: 10.1016/s0166-2236(00)01562-9.

    PubMed 10838596

  • Finklestein S, Campbell A, Baldessarini RJ, Moya KL, Haber SN. Late changes in cerebral monoamine metabolism following focal ventrolateral cerebrocortical lesions in rats. Brain Res. 1985 Oct 7;344(2):205-10. doi: 10.1016/0006-8993(85)90796-6.

    PubMed 2412650

  • Finklestein S, Campbell A, Stoll AL, Baldessarini RJ, Stinus L, Paskevitch PA, Domesick VB. Changes in cortical and subcortical levels of monoamines and their metabolites following unilateral ventrolateral cortical lesions in the rat. Brain Res. 1983 Jul 25;271(2):279-88. doi: 10.1016/0006-8993(83)90290-1.

    PubMed 6193832

  • Boyeson MG, Feeney DM. Striatal dopamine after cortical injury. Exp Neurol. 1985 Aug;89(2):479-83. doi: 10.1016/0014-4886(85)90107-4.

    PubMed 4018214

  • Stroemer RP, Kent TA, Hulsebosch CE. Enhanced neocortical neural sprouting, synaptogenesis, and behavioral recovery with D-amphetamine therapy after neocortical infarction in rats. Stroke. 1998 Nov;29(11):2381-93; discussion 2393-5. doi: 10.1161/01.str.29.11.2381.

    PubMed 9804653

  • Cramer SC, Nelles G, Benson RR, Kaplan JD, Parker RA, Kwong KK, Kennedy DN, Finklestein SP, Rosen BR. A functional MRI study of subjects recovered from hemiparetic stroke. Stroke. 1997 Dec;28(12):2518-27. doi: 10.1161/01.str.28.12.2518.

    PubMed 9412643

  • Feeney DM, Gonzalez A, Law WA. Amphetamine, haloperidol, and experience interact to affect rate of recovery after motor cortex injury. Science. 1982 Aug 27;217(4562):855-7. doi: 10.1126/science.7100929.

    PubMed 7100929

  • Gladstone DJ, Black SE. Enhancing recovery after stroke with noradrenergic pharmacotherapy: a new frontier? Can J Neurol Sci. 2000 May;27(2):97-105.

    PubMed 10830340

  • Goldstein LB. Potential impact of drugs on poststroke motor recovery. In: L. B. Goldstein, ed. Restorative Neurology. Advances in pharmacotherapy for recovery after stroke. Armonk, NY: Futura Publishing Co., 1998:241-256.

  • Scheidtmann K, Fries W, Muller F, Koenig E. Effect of levodopa in combination with physiotherapy on functional motor recovery after stroke: a prospective, randomised, double-blind study. Lancet. 2001 Sep 8;358(9284):787-90. doi: 10.1016/S0140-6736(01)05966-9.

    PubMed 11564483

  • Sullivan KJ, Knowlton BJ, Dobkin BH. Step training with body weight support: effect of treadmill speed and practice paradigms on poststroke locomotor recovery. Arch Phys Med Rehabil. 2002 May;83(5):683-91. doi: 10.1053/apmr.2002.32488.

    PubMed 11994808

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ropinirole (+ physical therapy) in people with Cerebrovascular Accident and Hemiparesis, run by University of California, Irvine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00221390, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.

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