<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03761511</url>
  </required_header>
  <id_info>
    <org_study_id>15-138</org_study_id>
    <nct_id>NCT03761511</nct_id>
  </id_info>
  <brief_title>Study of the Efficacy and Safety of Nicotinamide in Patients With Friedreich Ataxia</brief_title>
  <acronym>NICOFA</acronym>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicentre Study of the Efficacy and Safety of Nicotinamide in Patients With Friedreich Ataxia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RWTH Aachen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>RWTH Aachen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Friedreich ataxia is the most frequent early-onset autosomal recessive hereditary ataxia. It&#xD;
      is caused by a pathological expansion of a GAA repeat in the first intron of the frataxin&#xD;
      gene (FXN) and results in decreased levels of FXN protein. FXN deficiency results in a&#xD;
      relentlessly progressive neurodegenerative condition which frequently presents around&#xD;
      puberty. Patients gradually lose coordination, become dysarthric and are frequently&#xD;
      wheel-chair bound as adolescents. There is no disease modifying therapy and many patients die&#xD;
      prematurely of cardiomyopathy. It was subsequently found that the FXN gene is silenced at the&#xD;
      chromatin level by the formation of heterochromatin and that this heterochromatin formation&#xD;
      can be antagonized by histone deacetylase inhibitors (HDACi) (Chan et al., 2013). A recent&#xD;
      proof-of-concept clinical study on ten patients with Friedreich ataxia demonstrated that FXN&#xD;
      levels can be restored to those seen in asymptomatic carriers using the class III HDACi&#xD;
      nicotinamide at a dose that is well tolerated by patients (Libri et al., 2014). Since&#xD;
      carriers are asymptomatic, this degree of restoration of FXN expression might be expected to&#xD;
      halt disease progression. Nicotinamide readily crosses the blood brain barrier and has&#xD;
      previously been given at high doses for long periods to normal individuals without serious&#xD;
      adverse effects (Gale et al., 2004; Knip et al., 2000). This study will be the first to&#xD;
      provide clinical evidence for the efficacy and safety of nicotinamide in patients with&#xD;
      Friedreich´s ataxia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">April 2023</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Scale for the Assessment and Rating of Ataxia (SARA)</measure>
    <time_frame>1 year</time_frame>
    <description>The primary objective of the study is to evaluate the efficacy of daily doses of nicotinamide in slowing disease progression as measured by changes in the Scale for the Assessment and Rating of Ataxia (SARA) as compared with placebo in patients with Friedreich ataxia.&#xD;
The SARA is a tool for assessing ataxia. It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia). When completing the outcome measure each category is assessed and scored accordingly. Scores for the eight items range as follows:&#xD;
Gait (0-8 points), Stance (0-6 points), Sitting (0-4 points) Speech disturbance (0-6 points) Finger chase (0-4 points) Nose-finger test (0-4 points) Fast alternating hand movement (0-4 points) Heel-shin slide (0-4 points) Once each of the 8 categories have been assessed, the total is calculated to determine the severity of ataxia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression of quality of life measures via questionnaire EuroQol five dimensions questionnaire (EQ-5D)</measure>
    <time_frame>1 year</time_frame>
    <description>This is a generic instrument, developed and validated by the EuroQoL Group (1990), in which the patient self-rates in particular his/her health status on a visual analogue scale (VAS); the best score is 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Friedreich Ataxia Rating Scale (mFARS)</measure>
    <time_frame>1 year</time_frame>
    <description>Modified FARS scores are defined as the sum of scores for bulbar function, upper limb coordination, lower limb coordination, and upright stability. The mFARS consists of three subscales, comprising a general score for ataxia, a score for activities of daily living and a neurological examination. The scores can be added to make a total score ranging from 0 to 159. A higher score indicates a greater level of disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression of cerebellar severity measured by 'Composite Cerebellar Functional Severity´ (CCFS) score</measure>
    <time_frame>1 year</time_frame>
    <description>CCFS includes two tests performed with the dominant hand,named the click test and the 9 holes pegboard test (9HPT). An electronic device was created to perform CCFS and to calculate the Z score by subtracting the expected time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician's Global Impression-Change Scale (CGI-C) including comparison of change to the last visit</measure>
    <time_frame>1 year</time_frame>
    <description>The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1. Very much improved; 2. Much improved; 3. Minimally improved; 4. No change; 5. Minimally worse; 6. Much worse; 7. Very much worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety issues measured by appearance of AEs/SAEs</measure>
    <time_frame>1 year</time_frame>
    <description>AEs may be volunteered spontaneously by the patient, or discovered as a result of general non-directed questioning by the study personnel or by physical examination.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">225</enrollment>
  <condition>Friedreich Ataxia</condition>
  <arm_group>
    <arm_group_label>Treatment arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nicotinamide 4 g (capsules) or highest tolerated dose with a minimum of 2 g/d per os once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching Placebo (capsules) once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotinamide</intervention_name>
    <description>Nicotinamide 4 g (capsules) or highest tolerated dose with a minimum of 2 g/d per os once daily</description>
    <arm_group_label>Treatment arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching Placebo (capsules) once daily</description>
    <arm_group_label>Placebo arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have a molecular genetic diagnosis of Friedreich ataxia with a GAA-&#xD;
             repeat expansion on both alleles of the FXN gene and a SARA Score &gt;7 and &lt;28 and age&#xD;
             &lt;50 years.&#xD;
&#xD;
          -  Patients must be ≥18 years old and have a weight of at least 50kg.&#xD;
&#xD;
          -  Written informed consent prior to study participation&#xD;
&#xD;
          -  A female subject is eligible to participate if she is of: Non-childbearing potential&#xD;
             defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or&#xD;
             postmenopausal defined as 12 months of spontaneous amenorrhea or of childbearing&#xD;
             potential and agrees to&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any medical condition or illness that, in the opinion of the&#xD;
             investigator would interfere with study compliance and/or impair the patient´s ability&#xD;
             to participate or complete the study.&#xD;
&#xD;
          -  Any uncontrolled medical or neurological/neurodegenerative condition (other than&#xD;
             Friedreich ataxia).&#xD;
&#xD;
          -  Clinically significant psychiatric illness (e.g., uncontrolled major depression,&#xD;
             schizophrenia, bipolar affective disorder) within 6 months prior to screening.&#xD;
&#xD;
          -  Patients with significant clinical dysphagia.&#xD;
&#xD;
          -  Hypersensitivity to nicotinamide.&#xD;
&#xD;
          -  Patients known to be positive for human immunodeficiency virus (HIV).&#xD;
&#xD;
          -  Patients with a significant history of substance abuse (e.g. alcohol or drug abuse)&#xD;
             within the previous six months before enrolment.&#xD;
&#xD;
          -  Patients with a history of severe allergies to medications.&#xD;
&#xD;
          -  Indication of impaired liver function as shown by an abnormal liver function profile&#xD;
             at screening (e.g., repeated values of aspartate aminotransferase [AST], alanine&#xD;
             aminotransferase [ALT] and bilirubin ≥3 × the upper limit of normal).&#xD;
&#xD;
          -  History of malignancy or carcinoma. The following exceptions may be made after&#xD;
             discussion with the Sponsor:&#xD;
&#xD;
               -  Subjects with cancers in remission more than 5 years prior to screening.&#xD;
&#xD;
               -  Subjects with a history of excised or treated basal cell or squamous carcinoma.&#xD;
&#xD;
               -  Subjects with prostate cancer in situ.&#xD;
&#xD;
          -  History or evidence of an autoimmune disorder considered clinically significant by the&#xD;
             Investigator or requiring chronic use of systemic corticosteroids or other&#xD;
             immunosuppressants.&#xD;
&#xD;
          -  The subject has a history of any other illness, which, in the opinion of the&#xD;
             Investigator, might pose an unacceptable risk by administering study medication.&#xD;
&#xD;
          -  History of clinically significant cardiac disease (ejection fraction &lt; 40% [normal&#xD;
             range 50-70%], cardiac insufficiency defined as New York Heart Association [NYHA]&#xD;
             Class &gt;2; clinically significant congenital or acquired valvular disease; symptomatic&#xD;
             coronary disease such as prior myocardial infarction or angina, B-type natriuretic&#xD;
             peptide (BNP) level increase more than 2 x of the normal age- and gender dependent&#xD;
             range; history of unstable arrhythmias, history of atrial fibrillation).&#xD;
&#xD;
          -  The subject received an investigational drug within 30 days prior to inclusion into&#xD;
             this study.&#xD;
&#xD;
          -  Patients taking sodium valproate, tranylcypromine or any other known histone&#xD;
             deacetylase inhibitor.&#xD;
&#xD;
          -  Use of vitamin B1 (thiamine), withdrawal should be at least 3 months prior screening&#xD;
             or 5 half-lives, whichever is longer.&#xD;
&#xD;
          -  Use of vitamin B3 (nicotinamide), withdrawal should be at least 3 months prior&#xD;
             screening.&#xD;
&#xD;
          -  If patients are taking idebenone or coenzyme Q10 (CoQ), this should be stable over the&#xD;
             last three months and not changed during the study.&#xD;
&#xD;
          -  The subject is unwilling or unable to provide written informed consent and to follow&#xD;
             the procedures outlined in the protocol.&#xD;
&#xD;
          -  For subjects who will undergo an MRI: Any contraindications to MRI such as, but not&#xD;
             limited to cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid&#xD;
             artery vascular clamp, neurostimulator, implanted drug infusion devices, metal&#xD;
             fragments or foreign objects in the eyes, skin or body, bone growth/fusion stimulator,&#xD;
             cochlear, otologic implant, severe claustrophobia or any condition that would&#xD;
             counterindicate an MRI scan.&#xD;
&#xD;
          -  Patients participating at start or have been within 30 days before start of study in&#xD;
             another pharmacological and non-pharmacological clinical trial, excluding natural&#xD;
             history / observational studies.&#xD;
&#xD;
          -  The subject is mentally or legally incapacitated.&#xD;
&#xD;
          -  Pregnant females as determined by positive [serum or urine] hCG test at Screening or&#xD;
             prior to dosing. Participants of child-bearing age should use adequate contraception&#xD;
             as defined in the study protocol.&#xD;
&#xD;
          -  Lactating females.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <contact>
      <last_name>Sylvia Boesch, PD Dr.</last_name>
      <email>sylvia.boesch@i-med.ac.at</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Service de génétique médicale - Hôpital La Pitié Salpetrière</name>
      <address>
        <city>Paris</city>
        <zip>75646</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Alexandra Durr, Prof. Dr.</last_name>
      <phone>: +33 (0) 1 57 27 40 00</phone>
      <email>alexandra.durr@upmc.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital RWTH Aachen</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
    <contact>
      <last_name>Jörg B. Schulz, Univ.-Prof.</last_name>
      <email>jschulz@ukaachen.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Neurologico Carlo Besta</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Caterina Mariotti, Prof. Dr.</last_name>
      <email>Caterina.Mariotti@istituto-besta.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Francisco Javier Rodríguez de Rivera Garrido, Prof. Dr.</last_name>
      <email>frriveragarrido@salud.madrid.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Imperial College London</name>
      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London</name>
      <address>
        <city>London</city>
        <zip>WC1N 3BG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Paola Giunti, Prof. Dr.</last_name>
      <email>p.giunti@ucl.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Friedreich Ataxia</keyword>
  <keyword>Nicotinamide</keyword>
  <keyword>Rare disease</keyword>
  <keyword>ZSEA</keyword>
  <keyword>SARA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ataxia</mesh_term>
    <mesh_term>Cerebellar Ataxia</mesh_term>
    <mesh_term>Friedreich Ataxia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Niacinamide</mesh_term>
    <mesh_term>Niacin</mesh_term>
    <mesh_term>Nicotinic Acids</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The study results will be published in appropriate international scientific journals, and publishing details will be given in the clinical study agreement. The study will be registered and study results will be disclosed by the principal investigator in one or more public clinical study registry(ies), according to national/international use.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>NICOFA</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://ukaachen.sharepoint.com/:b:/s/NICOFA/ESUAT8h1fTBHlTcsdu48LrQBbvvAABdsy81bvQ4Egq696g?e=8Xliis</doc_url>
    </study_doc>
  </study_docs>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03761511/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03761511
org study id: 15-138
nct id: NCT03761511
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Friedreich ataxia is the most frequent early-onset autosomal recessive hereditary ataxia. It
      is caused by a pathological expansion of a GAA repeat in the first intron of the frataxin
      gene (FXN) and results in decreased levels of FXN protein. FXN deficiency results in a
      relentlessly progressive neurodegenerative condition which frequently presents around
      puberty. Patients gradually lose coordination, become dysarthric and are frequently
      wheel-chair bound as adolescents. There is no disease modifying therapy and many patients die
      prematurely of cardiomyopathy. It was subsequently found that the FXN gene is silenced at the
      chromatin level by the formation of heterochromatin and that this heterochromatin formation
      can be antagonized by histone deacetylase inhibitors (HDACi) (Chan et al., 2013). A recent
      proof-of-concept clinical study on ten patients with Friedreich ataxia demonstrated that FXN
      levels can be restored to those seen in asymptomatic carriers using the class III HDACi
      nicotinamide at a dose that is well tolerated by patients (Libri et al., 2014). Since
      carriers are asymptomatic, this degree of restoration of FXN expression might be expected to
      halt disease progression. Nicotinamide readily crosses the blood brain barrier and has
      previously been given at high doses for long periods to normal individuals without serious
      adverse effects (Gale et al., 2004; Knip et al., 2000). This study will be the first to
      provide clinical evidence for the efficacy and safety of nicotinamide in patients with
      Friedreich´s ataxia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Scale for the Assessment and Rating of Ataxia (SARA)
time frame: 1 year
description: The primary objective of the study is to evaluate the efficacy of daily doses of nicotinamide in slowing disease progression as measured by changes in the Scale for the Assessment and Rating of Ataxia (SARA) as compared with placebo in patients with Friedreich ataxia.
The SARA is a tool for assessing ataxia. It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia). When completing the outcome measure each category is assessed and scored accordingly. Scores for the eight items range as follows:
Gait (0-8 points), Stance (0-6 points), Sitting (0-4 points) Speech disturbance (0-6 points) Finger chase (0-4 points) Nose-finger test (0-4 points) Fast alternating hand movement (0-4 points) Heel-shin slide (0-4 points) Once each of the 8 categories have been assessed, the total is calculated to determine the severity of ataxia.
measure: Progression of quality of life measures via questionnaire EuroQol five dimensions questionnaire (EQ-5D)
time frame: 1 year
description: This is a generic instrument, developed and validated by the EuroQoL Group (1990), in which the patient self-rates in particular his/her health status on a visual analogue scale (VAS); the best score is 100.
measure: Modified Friedreich Ataxia Rating Scale (mFARS)
time frame: 1 year
description: Modified FARS scores are defined as the sum of scores for bulbar function, upper limb coordination, lower limb coordination, and upright stability. The mFARS consists of three subscales, comprising a general score for ataxia, a score for activities of daily living and a neurological examination. The scores can be added to make a total score ranging from 0 to 159. A higher score indicates a greater level of disability.
measure: Progression of cerebellar severity measured by 'Composite Cerebellar Functional Severity´ (CCFS) score
time frame: 1 year
description: CCFS includes two tests performed with the dominant hand,named the click test and the 9 holes pegboard test (9HPT). An electronic device was created to perform CCFS and to calculate the Z score by subtracting the expected time
measure: Clinician's Global Impression-Change Scale (CGI-C) including comparison of change to the last visit
time frame: 1 year
description: The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1. Very much improved; 2. Much improved; 3. Minimally improved; 4. No change; 5. Minimally worse; 6. Much worse; 7. Very much worse
measure: Safety issues measured by appearance of AEs/SAEs
time frame: 1 year
description: AEs may be volunteered spontaneously by the patient, or discovered as a result of general non-directed questioning by the study personnel or by physical examination.
arm group label: Treatment arm
arm group type: Active Comparator
description: Nicotinamide 4 g (capsules) or highest tolerated dose with a minimum of 2 g/d per os once daily
arm group label: Placebo arm
arm group type: Placebo Comparator
description: Matching Placebo (capsules) once daily
intervention type: Drug
intervention name: Nicotinamide
description: Nicotinamide 4 g (capsules) or highest tolerated dose with a minimum of 2 g/d per os once daily
arm group label: Treatment arm
intervention type: Drug
intervention name: Placebo
description: Matching Placebo (capsules) once daily
arm group label: Placebo arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
facility: 
contact: 
country: Austria
country: France
country: Germany
country: Italy
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Ataxia
mesh term: Cerebellar Ataxia
mesh term: Friedreich Ataxia
mesh term: Niacinamide
mesh term: Niacin
mesh term: Nicotinic Acids
sharing ipd: Undecided
ipd description: The study results will be published in appropriate international scientific journals, and publishing details will be given in the clinical study agreement. The study will be registered and study results will be disclosed by the principal investigator in one or more public clinical study registry(ies), according to national/international use.
study doc: 
provided document: 