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Analysis of Pain and Quality of Life in Patients With Charcot-Marie-Tooth Neuropathy (CMT)

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ClinicalTrials.gov Identifier: NCT03966287
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Michael W Sereda, MD, Professor of Neurology, University Medical Center Goettingen

Brief Summary:
The study aims to qualitatively and quantitively evaluate pain in patients suffering from CMT with 3 standardized questionnaires (SF-36, NPSI-G, PAIN DETECT) as well as its impact on the quality of life.

Condition or disease
CMT

Detailed Description:

Hereditary neuropathies are a group of clinically and genetically heterogeneous diseases of the peripheral nervous system. Charcot-Marie-Tooth disease (CMT), also known as hereditary motor and sensory neuropathy (HMSN), is the most common form of hereditary neuropathy with a prevalence of approximately 1 in 2,500 and with approximately 30,000 affected persons in Germany. There is no therapy known so far. In addition to the characteristic symptoms of a distal to proximal progressive symmetric muscular atrophy, especially of the lower extremities, there is a weakening of the muscles of the lower legs and feet, with emphasis on the "small" foot muscles and the peroneal muscle group, which clinically manifests as a so-called "stepper gait". It is also known that many CMT patients additionally suffer from pain, but more detailed studies on pain quality and quantity and their impact on patients' quality of life have not yet been systematically performed. These parameters will be investigated in this study, supported by the company Grünenthal, in the form of a questionnaire survey with validated questionnaires on pain and quality of life for at least 200 CMT patients. A representative result could lead to further investigations of pain in CMT patients and ultimately to the development of an adequate pain therapy.

Recruitment of patients will occur mainly through a call of the Germany-wide CMT registry, which is part of the national research network CMT-NET (coordinator: Prof. Michael Sereda). Interested patients are invited to contact the study team at the UMG. The patients will be informed about the study and if further interested 4 questionnaires (1 regarding the personal history as well as 3 standardized questionnaires from literature regarding quality of life and pain (SF-36, NPSI-G, PAIN DETECT) will be sent to the patients together with obligatory study documents and a pre-franked return envelope. A personal visit at the UMG is not planned, so that the patients don´t have any expenses. The data are pseudonymized at the UMG and transferred to a database and finally statistically evaluated by Gruenenthal.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Analysis of Pain and Quality of Life in Patients With Charcot-Marie-Tooth Neuropathy (CMT)
Estimated Study Start Date : June 3, 2019
Estimated Primary Completion Date : July 15, 2019
Estimated Study Completion Date : December 31, 2019





Primary Outcome Measures :
  1. SF-36 Questionnaire [ Time Frame: 1 year ]
    Questionnaire to evaluate health status

  2. NPSI-G Questionnaire [ Time Frame: 1 day ]
    Questionnaire to discriminate neuropathic and non-neuropathic pain

  3. PAIN DETECT Questionnaire [ Time Frame: 4 weeks ]
    Questionnaire for the diagnosis of neuropathic pain (intensity, pattern, quality)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
German-wide, registered patients in CMT-registry
Criteria

Inclusion Criteria:

  • Clinical diagnosis of CMT
  • Genetic confirmation of CMT diagnosis
  • Age between 18 and 65 years
  • Signed consent form

Exclusion Criteria:

  • Other relevant neurological or psychiatric diseases, acute or past
  • Serious internal medical illness
  • Drug and / or alcohol dependence
  • Participation in another clinical trial within 4 weeks prior to enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03966287


Contacts
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Contact: Lisa Reinecke, Dr. +49 551 39 ext 9662 knp.cmt-register@med.uni-goettingen.de

Locations
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Germany
University Medical Centre Recruiting
Goettigen, Germany, 37075
Contact: Lisa Reinecke, Dr.    +49 551 39 ext 9662    lisa.reinecke@med.uni-goettingen.de   
Sponsors and Collaborators
University Medical Center Goettingen

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Responsible Party: Michael W Sereda, MD, Professor of Neurology, Prof. Dr. Michael W. Sereda, University Medical Center Goettingen
ClinicalTrials.gov Identifier: NCT03966287     History of Changes
Other Study ID Numbers: 02202
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Nervous System Malformations
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn