Does the drug Pramipexole improve the verbal communication ability of stroke patients with impaired language function?

The effect of Pramipexole on recovery from chronic post-stroke aphasia - Pramipexole in aphasia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002396-17-GB

Enrollment

Registered

2013-08-02

Start date

2013-12-04

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-stroke aphasia

Interventions

Product Name: Pramipexole Pharmaceutical Form: Tablet INN or Proposed INN: pramipexole Concentration unit: µg microgram(s) Pharmaceutica

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: First-ever stroke at least 6 months prior to the start of the study and resulting in severe or moderately severe predominantly expressive aphasia. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Parkinson’s disease Major depressive illness Significant cognitive impairment Severe renal impairment Known hypersensitivity to dopamine agonists, pregnancy, breast feeding or psychosis Patients for whom English is not the first language will also be excluded because of concerns about the validity and reliability of the translated versions of the Western Aphasia Battery.

Design outcomes

Primary

Measure	Time frame
Main Objective: Does Pramipexole when combined with standard speech and language therapy improve the clinical outcomes better than standard speech and language therapy alone in chronic post-stroke aphasia?;Secondary Objective: NA;Primary end point(s): Change in language function as measured with the Western Aphasia Battery;Timepoint(s) of evaluation of this end point: Completition of treatment and follow up - end of week 8 of study.	—

Measure

Time frame

Main Objective: Does Pramipexole when combined with standard speech and language therapy improve the clinical outcomes better than standard speech and language therapy alone in chronic post-stroke aphasia?;Secondary Objective: NA;Primary end point(s): Change in language function as measured with the Western Aphasia Battery;Timepoint(s) of evaluation of this end point: Completition of treatment and follow up - end of week 8 of study.

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

United Kingdom

Contacts

Public ContactDr. Clive Thursfield

Birmingham Community Healthcare NHS Trust

Clive.thursfield@bhamcommunity.nhs.uk01214663042

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026