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Trial record 17 of 302 for:    Recruiting, Not yet recruiting, Available Studies | "Tooth Diseases"

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

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

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.

Condition or disease Intervention/treatment Phase
Chronic Inflammatory Demyelinating Polyneuropathy Peripheral Neuropathy Charcot-Marie-Tooth Disease Charcot-Marie-Tooth Disease Type 1A Charcot-Marie-Tooth Disease, Type IA Drug: MD1003 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2016
Estimated Primary Completion Date : December 2017


Arm Intervention/treatment
Experimental: MD1003 Drug: MD1003



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. Timed 10-meter walk test [ Time Frame: 48 weeks ]
  3. Medical Research Council (MRC) sum score [ Time Frame: 48 weeks ]
  4. INCAT Sensory Sum Score (ISS) [ Time Frame: 48 weeks ]
  5. 6-minute walk test [ Time Frame: 48 weeks ]
  6. Posturometry [ Time Frame: 48 weeks ]
  7. Supernormality (%) [ Time Frame: 48 weeks ]
  8. Strength-duration time constant (ms) [ Time Frame: 48 weeks ]
  9. Rheobase (mA) [ Time Frame: 48 weeks ]
  10. Refractoriness (%) [ Time Frame: 48 weeks ]
  11. Min-max absolute refractory period (ms) [ Time Frame: 48 weeks ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02967679


Contacts
Contact: abdelkarim Bendarraz contact@medday-pharma.com

Locations
France
Hôpital Henri Mondor, Créteil, France Recruiting
Creteil, France, 94010
Contact: Alain CREANGE, MD    +33149812315    alain.creange@aphp.fr   
Sponsors and Collaborators
MedDay Pharmaceuticals SA
Investigators
Principal Investigator: Alain CREANGE, MD Hôpital Henri Mondor, Créteil, France
Study Director: Frederic Sedel, MD Medday Pharmaceuticals

Additional Information:
Responsible Party: MedDay Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT02967679     History of Changes
Other Study ID Numbers: MD1003CT2015-01-SERENDEM
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by MedDay Pharmaceuticals SA:
Neuropathy
Demyelinating polyradiculoneuropathy

Additional relevant MeSH terms:
Tooth Diseases
Charcot-Marie-Tooth Disease
Peripheral Nervous System Diseases
Polyneuropathies
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Neuromuscular Diseases
Nervous System Diseases
Stomatognathic Diseases
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases