NCT01441284

Brief Summary

Aim of the study is to perform a double-blind, crossover, placebo-controlled multicenter study evaluating the efficacy of pramipexole on essential tremor.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 27, 2011

Completed
6.2 years until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

September 21, 2011

Last Update Submit

May 4, 2017

Conditions

Essential Tremor

Keywords

pramipexoleessential tremorcross-over

Outcome Measures

Primary Outcomes (1)

  • Improvement in tremor severity

    Improvement in tremor severity measured by Fahn-Tolosa-Marin Tremor Rating Scale

    10 weeks of treatment

Secondary Outcomes (2)

  • Improvement in quality of life

    10 weeks of treatment

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    10 weeks of treatment

Study Arms (2)

Process 1

ACTIVE COMPARATOR

10 weeks of pramipexole treatment 2 weeks wash-out period (cross-over) 10 weeks placebo treatment

Drug: pramipexoleDrug: placebo

Process 2

PLACEBO COMPARATOR

10 weeks of placebo treatment 2 weeks wash-out period (cross-over) 10 weeks pramipexole treatment

Drug: pramipexoleDrug: placebo

Interventions

pramipexoleDRUG

pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily

Also known as: Mirapexin retard
Process 1Process 2
placeboDRUG

placebo

Process 1Process 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of ET has to be unambiguous based on the clinical diagnostic criteria.
  • Tremor has to be severe enough to produce disability.
  • Patients must sign a written informed consent according with the approval of the Regional Ethical Board of University of Pécs

You may not qualify if:

  • Presence of any medical conditions capable of producing tremor (e.g. hyperthyroidism, drug withdrawal, neuropathy, etc.).
  • Except for cogwheel phenomenon, the presence of any abnormal neurological signs (e.g. dystonia, myoclonus, ataxia, parkinsonism, cerebellar or pyramidal signs, etc.)
  • Atypical tremor appearance for ET (e.g. isolated vocal-cord tremor, orthostatic tremor, task-specific tremor, etc.)
  • Presence or suspicion of psychogenic tremor
  • Usage of medication capable of producing tremor (e.g. sympathomimetics, valproate, etc.)
  • Concomitant administration of any drugs potentially capable of improving ET (e.g. antiepileptics, beta-receptor blockers).
  • Previous neurosurgical treatment (e.g. deep brain stimulation or thalamotomy).
  • Presence of serious concomitant disorders capable of interfering with the study (e.g. heart failure, tumorous disorders, etc.)
  • Presence of any contraindication for pramipexole treatment (e.g. impulsive control disorder, known hypersensitivity to any components of the tablets, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Neurology, University of Pécs

Pécs, Baranya, H-7623, Hungary

Location

Kaposi Mór County Hospital

Kaposvár, Somogy County, H-7400, Hungary

Location

Related Publications (1)

  • Kovács N, Pál E, Késmárky I, Komoly S, Nagy F, Herceg M. Pramipexole for treating essential tremor. Eur J Neurol 2011;18(Suppl 2):482.

    BACKGROUND

MeSH Terms

Conditions

Essential Tremor

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

BenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Norbert Kovacs, MD, PhD

    Associate professor

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, specialist in neurology and movement disorders, Department of Neurology

Study Record Dates

First Submitted

September 21, 2011

First Posted

September 27, 2011

Study Start

December 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations

HU(2)