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Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor

Sponsor
University of Pecs (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01441284
Collaborator
(none)
0
Enrollment
2
Locations
2
Arms
12
Anticipated Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Essential tremor is one of the most common movement disorders with the prevalence of 3-5% among the elderly population. Although its main clinical feature is the bilateral, predominantly postural-kinetic tremor, newer studies suggest that ET is a spectrum of clinical features with both motor and nonmotor elements not homogeneously distributed.

Despite its high occurrence, the pharmacological treatment of ET is limited. Although the mainline drugs, propranolol and primidone, can provide good clinical benefit in a portion of cases, >50% of the patients stop the medication due to inefficacy or side-effects. Hypotension, dizziness, bradycardia, cognitive impairment, fatigue and erectile dysfunction are the most common side-effects contributing to medication discontinuation.

In an open-label pilot study, the investigators previously demonstrated that 2.1 mg/day pramipexole extended-release improved both the severity of tremor (by 52%) and health-related quality of life.

The present study aims to confirm this hypothesis in a double-blind, crossover, placebo-controlled multicenter study.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor: a Double-blind, Cross-over, Placebo-controlled Multicenter Study
Anticipated Study Start Date :
Dec 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Process 1

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

Drug: pramipexole
pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily
Other Names:
  • Mirapexin retard

    • Drug: placebo
    placebo
    Placebo Comparator: Process 2

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

    Drug: pramipexole
    pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily
    Other Names:
  • Mirapexin retard

    • Drug: placebo
    placebo

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in tremor severity [10 weeks of treatment]

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

    Secondary Outcome Measures

    1. Improvement in quality of life [10 weeks of treatment]

      Improvement in quality of life assessed by EQ-5D score

    2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [10 weeks of treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • Exclusion criteria are established in accordance to the guidelines of Elble et al3.

    • 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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Neurology, University of Pécs Pécs Baranya Megye Hungary H-7623
    2 Kaposi Mór County Hospital Kaposvár Somogy Megye Hungary H-7400

    Sponsors and Collaborators

    • University of Pecs

    Investigators

    • Principal Investigator: Norbert Kovacs, MD, PhD, Associate professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. Norbert Kovacs, Associate professor, specialist in neurology and movement disorders, Department of Neurology, University of Pecs
    ClinicalTrials.gov Identifier:
    NCT01441284
    Other Study ID Numbers:
    • AOK_KA_2011_pramipexole
    • 34039/KA-OTKA/11-10
    First Posted:
    Sep 27, 2011
    Last Update Posted:
    May 8, 2017
    Last Verified:
    May 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. Norbert Kovacs, Associate professor, specialist in neurology and movement disorders, Department of Neurology, University of Pecs
    pramipexole
    essential tremor
    cross-over
    Additional relevant MeSH terms:
    Tremor
    Essential Tremor
    Pramipexole

    Study Results

    No Results Posted as of May 8, 2017