Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Pecs.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Norbert Kovacs, University of Pecs
ClinicalTrials.gov Identifier:
NCT01441284
First received: September 21, 2011
Last updated: December 15, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Essential Tremor
Drug: pramipexole
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Pecs:

Primary Outcome Measures:
  • Improvement in tremor severity [ Time Frame: 10 weeks of treatment ] [ Designated as safety issue: No ]
    Improvement in tremor severity measured by Fahn-Tolosa-Marin Tremor Rating Scale


Secondary Outcome Measures:
  • Improvement in quality of life [ Time Frame: 10 weeks of treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Mirapexin retard
Drug: placebo
placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441284

Contacts
Contact: Norbert Kovacs, MD, PhD +3672536001 ext 7642 kovacsnorbert06@gmail.com

Locations
Hungary
Department of Neurology, University of Pécs Not yet recruiting
Pécs, Baranya Megye, Hungary, H-7623
Contact: Norbert Kovacs, MD, PhD    +3672536001 ext 37642    kovacsnorbert06@gmail.com   
Principal Investigator: Norbert Kovacs, MD, PhD         
Kaposi Mór County Hospital Not yet recruiting
Kaposvár, Somogy Megye, Hungary, H-7400
Contact: Ferenc Nagy, MD, PhD       fnagy8@yahoo.com   
Principal Investigator: Ferenc Nagy, MD, PhD         
Sponsors and Collaborators
University of Pecs
Investigators
Principal Investigator: Norbert Kovacs, MD, PhD Associate professor
  More Information

No publications provided

Responsible Party: Dr. Norbert Kovacs, Associate professor, specialist in neurology and movement disorders, Department of Neurology, University of Pecs
ClinicalTrials.gov Identifier: NCT01441284     History of Changes
Other Study ID Numbers: AOK_KA_2011_pramipexole, 34039/KA-OTKA/11-10
Study First Received: September 21, 2011
Last Updated: December 15, 2011
Health Authority: Hungary: Institutional Ethics Committee

Keywords provided by University of Pecs:
pramipexole
essential tremor
cross-over

Additional relevant MeSH terms:
Essential Tremor
Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 01, 2014