Motor function optimization in advanced Parkinson’s disease patients, combined with galantamine to prevent visual hallucinations.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006278-13-NL

Enrollment

Registered

2008-10-15

Start date

2009-02-04

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

patients with advanced (>5 years) Parkinson's disease and visual hallucinations. MedDRA version: 9.1 Level: LLT Classification code 10047570 Term: Visual hallucinations MedDRA version: 9.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's

Interventions

Trade Name: Reminyl Retard Pharmaceutical Form: Capsule* Trade Name: Sinemet 125 mg Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 10 patients with advanced PD (>5 years) and visual hallucinations PD according to the UK Brain Bank Criteria At least weekly visual hallucinations Patients must be able to understand the procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Unstable internal disease Major depression MMSE<24 Use of the following medication: anticholinergics, amantadine, selegiline (washout at least 2 weeks), tricyclic antidepressants (washout al least 1 month), cholinesterase inhibitors

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if a stable optimal dose of galantamine can prevent an increase or emergence of VH after increase of L-dopa therapy. ;Secondary Objective: Secondly, the effect of galantamine on cognition and mood will be investigated.;Primary end point(s): Severity of VH after an increase of the L-dopa dose, combined with galantamine vs. an increase without galantamine as measured by the UM-PDHQ (percentage change on the UM-PDHQ).	—

Measure

Time frame

Main Objective: To investigate if a stable optimal dose of galantamine can prevent an increase or emergence of VH after increase of L-dopa therapy. ;Secondary Objective: Secondly, the effect of galantamine on cognition and mood will be investigated.;Primary end point(s): Severity of VH after an increase of the L-dopa dose, combined with galantamine vs. an increase without galantamine as measured by the UM-PDHQ (percentage change on the UM-PDHQ).

—

Countries

Netherlands

Outcome results

None listed

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