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Trial record 20 of 25 for:    nerve | CIDP

SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study

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ClinicalTrials.gov Identifier: NCT02967679
Recruitment Status : Unknown
Verified November 2016 by MedDay Pharmaceuticals SA.
Recruitment status was:  Recruiting
First Posted : November 18, 2016
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
MedDay Pharmaceuticals SA

Tracking Information
First Submitted Date  ICMJE November 8, 2016
First Posted Date  ICMJE November 18, 2016
Last Update Posted Date November 18, 2016
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
  • Motor nerve conduction velocity (m/sec) [ Time Frame: 48 weeks ]
    A 10% improvement for 2 out of these 4 criteria, in at least 3 out of 8 nerves will be considered as clinically meaningful.
  • Distal latency (msec) [ Time Frame: 48 weeks ]
    A 10% improvement for 2 out of these 4 criteria, in at least 3 out of 8 nerves will be considered as clinically meaningful.
  • F wave latency (msec) [ Time Frame: 48 weeks ]
    A 10% improvement for 2 out of these 4 criteria, in at least 3 out of 8 nerves will be considered as clinically meaningful.
  • Length of motor nerve potential [ Time Frame: 48 weeks ]
    A 10% improvement for 2 out of these 4 criteria, in at least 3 out of 8 nerves will be considered as clinically meaningful.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
  • ONLS (Overall Neuropathy Limitations Scale) [ Time Frame: 48 weeks ]
    Secondary endpoints will be part of exploratory analyses. They will consist in studying mean change or proportions for the following clinical and electrophysiological parameters.
  • Timed 10-meter walk test [ Time Frame: 48 weeks ]
  • Medical Research Council (MRC) sum score [ Time Frame: 48 weeks ]
  • INCAT Sensory Sum Score (ISS) [ Time Frame: 48 weeks ]
  • 6-minute walk test [ Time Frame: 48 weeks ]
  • Posturometry [ Time Frame: 48 weeks ]
  • Supernormality (%) [ Time Frame: 48 weeks ]
  • Strength-duration time constant (ms) [ Time Frame: 48 weeks ]
  • Rheobase (mA) [ Time Frame: 48 weeks ]
  • Refractoriness (%) [ Time Frame: 48 weeks ]
  • Min-max absolute refractory period (ms) [ Time Frame: 48 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study
Official Title  ICMJE Not Provided
Brief Summary The primary objective of the study is to assess the effect of MD1003 on motor and sensory conduction, in patients suffering from demyelinating polyneuropathies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Inflammatory Demyelinating Polyneuropathy
  • Peripheral Neuropathy
  • Charcot-Marie-Tooth Disease
  • Charcot-Marie-Tooth Disease Type 1A
  • Charcot-Marie-Tooth Disease, Type IA
Intervention  ICMJE Drug: MD1003
Study Arms  ICMJE Experimental: MD1003
Intervention: Drug: MD1003
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 15, 2016)
15
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female aged between 20 and 85 years.
  • Patients fulfilling one of the following diagnosis:
  • Five patients with chronic inflammatory demyelinating polyneuropathy on both clinical and neurophysiological grounds.
  • Five patients with proven genetic diagnosis of CMT1a
  • Five patients with anti-MAG polyneuropathy.
  • Electrophysiological parameters worsening for the past 3 years
  • Available EMG record, performed during the past 6 months to assess variability of NCV parameters

Exclusion Criteria:

  • Any general chronic handicapping disease other than peripheral neuropathy
  • Impossibility to perform the 10 meters walking test
  • Impossibility to assess electrophysiological parameters
  • Patients with uncontrolled hepatic disorder, renal or cardiovascular disease, or cancer,
  • Patients with hypersensitivity to MD1003 excipients (lactose)
  • Laboratory tests out of normal range according to the reference laboratory values. Deviations may be accepted if considered by the investigator as not clinically significant with regards to the study continuation,
  • Patients with history or presence of alcohol abuse or drug addiction,
  • Patients likely to be non-compliant to the study procedures or for whom a long-term follow-up seems to be difficult to achieve.
  • Any new medication for neuropathy initiated less than 3 months prior to inclusion. For CIDP patients, relapse in the past 3 months before inclusion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02967679
Other Study ID Numbers  ICMJE MD1003CT2015-01-SERENDEM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MedDay Pharmaceuticals SA
Study Sponsor  ICMJE MedDay Pharmaceuticals SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alain CREANGE, MD Hôpital Henri Mondor, Créteil, France
Study Director: Frederic Sedel, MD Medday Pharmaceuticals
PRS Account MedDay Pharmaceuticals SA
Verification Date November 2016

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