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Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor

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ClinicalTrials.gov Identifier: NCT01441284
Recruitment Status : Withdrawn (Lack of financial support)
First Posted : September 27, 2011
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Norbert Kovacs, University of Pecs

September 21, 2011
September 27, 2011
May 8, 2017
December 2017
December 2018   (Final data collection date for primary outcome measure)
Improvement in tremor severity [ Time Frame: 10 weeks of treatment ]
Improvement in tremor severity measured by Fahn-Tolosa-Marin Tremor Rating Scale
Same as current
Complete list of historical versions of study NCT01441284 on ClinicalTrials.gov Archive Site
  • Improvement in quality of life [ Time Frame: 10 weeks of treatment ]
    Improvement in quality of life assessed by EQ-5D score
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 10 weeks of treatment ]
Same as current
Not Provided
Not Provided
 
Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor
Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor: a Double-blind, Cross-over, Placebo-controlled Multicenter Study
Aim of the study is to perform a double-blind, crossover, placebo-controlled multicenter study evaluating the efficacy of pramipexole on essential tremor.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Essential Tremor
  • Drug: pramipexole
    pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily
    Other Name: Mirapexin retard
  • Drug: placebo
    placebo
  • Active Comparator: Process 1
    10 weeks of pramipexole treatment 2 weeks wash-out period (cross-over) 10 weeks placebo treatment
    Interventions:
    • Drug: pramipexole
    • Drug: placebo
  • Placebo Comparator: Process 2
    10 weeks of placebo treatment 2 weeks wash-out period (cross-over) 10 weeks pramipexole treatment
    Interventions:
    • Drug: pramipexole
    • Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
60
December 2018
December 2018   (Final data collection date for primary outcome measure)

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.)
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
 
NCT01441284
AOK_KA_2011_pramipexole
34039/KA-OTKA/11-10 ( Other Identifier: University of Pécs, Faculty of Medicine )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Dr. Norbert Kovacs, University of Pecs
University of Pecs
Not Provided
Principal Investigator: Norbert Kovacs, MD, PhD Associate professor
University of Pecs
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP