Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT00313677 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Clinical Trial Readiness for the Dystroglycanopathies

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Notable

    Primary completion date: Jul 2025 to Jul 2030

    Completion date: Jul 2026 to Jul 2030; Site contact updated; Publications: 7 to 18

    Show what changed: Publications
    Mathews KD, Stephan CM, Laubenthal K, Winder TL, Michele DE, Moore SA, Campbell KP. Myoglobinuria and muscle pain are common in patients with limb-girdle muscular dystrophy 2I. Neurology. 2011 Jan 11;76(2):194-5. doi: 10.1212/WNL.0b013e3182061ad4. No abstract available. Jensen BS, Willer T, Saade DN [...]

    Study Status, Oversight, Conditions, Outcome Measures, Contacts/Locations, Referencesv20

  2. Minor

    Enrollment target: 175 to 190

    Study Status, Study Design, Referencesv19

  3. Minor

    Enrollment target: 160 to 175

    Study Status, Study Designv18

  4. Minor

    Study description expanded, about 2 words

    Show what changed: Study description
    [...] dystroglycanopathies could have mutations in any one of the 18more than 20 currently identified genes, or evidence of dystroglycanopat [...]

    Study Status, Study Description, Conditionsv17

  5. Notable

    Primary completion date: Jul 2020 to Jul 2025

    Completion date: Jul 2020 to Jul 2026

    Study Statusv16

Show 14 earlier versions

  1. Minor

    Enrollment target: 120 to 160

    Primary and study completion dates: Mar 2020 to Jul 2020

    Study Status, Study Design, Referencesv15

  2. Minor

    Study Status, Sponsor/Collaborators

    Re-verified, no change to tracked fields

    v14

  3. Notable

    Lead sponsor: University of Iowa to Katherine Mathews

    Study Identification, Study Status, Sponsor/Collaboratorsv13

  4. Notable

    Primary completion date: Mar 2015 to Mar 2020

    Study description expanded, about 4 words

    Show what changed: Study description
    [...] Patients with dystroglycanopathies could have mutations in any one of the following18 currently identified genes: FKRP, fukutin, POMT1, POMT2, POMGnT1 or LARGEevidence of dystroglycanopathy in biopsied muscle tissue . Symptoms range from congenital muscular dystrophy that can alsomay involve the brain and eye, through an adult-onset limb gird [...]

    Study Status, Study Description, Conditions, Contacts/Locations, IPDSharing, Referencesv12

  5. Minor

    2 amendments

    2 re-verifications since 2012-01-04, no change to tracked fields

    v10-v11

  6. Minor

    Enrollment target: 100 to 120

    Eligibility criteria expanded, about 13 words; Study description shortened, about 47 words; Site contact updated; and 1 more

    Show all 5 changes in this update
    • Minor Enrollment target: 100 to 120
    • Minor Eligibility criteria expanded, about 13 words
      Show what changed
      Inclusion Criteria: SubjectsElevated withCK (creatine kinase) Evidence of a dystroglycanopathy as determined by review of muscle pathology OR documented mutation in one of the known FKRPgenes geneOR mutationsabnormal willalpha-dystroglycan beglycosylation enrolledin forcultured annual clinical examinations and collection of medical/health information.fibroblasts FKRP mutationsDystroglycanopathies are predicted to affect all racial and ethnic backgrounds, and all FKRP-MDpatients patientswith dystroglycanopathies will be eligible for participation. Participants may be of [...]
    • Minor Study description shortened, about 47 words
      Show what changed
      [...] e the clinical presentation of muscular dystrophy caused by changesabnormal inglycosylation theof fukutinalpha-related protein (FKRP) genedystroglycan. FKRPPatients with dystroglycanopathies could have mutations are responsible for limb-girdle muscular dystrophy type 2I (LGMD 2I) and congenital muscular dystrophy type 1C (MDC1C). Study researchers will also determine the reasons for differences in disease severity. This study has two phases. Participants may take part in both phases, or in one of the twofollowing genes: FKRP, fukutin, POMT1, POMT2, POMGnT1 or LARGE. ParticipantsSymptoms inrang [...] [...]
    • Minor Site contact updated
    • Minor Study title shortened, about 1 word
      Show what changed
      A Clinical EvaluationTrial ofReadiness FKRPfor Muscularthe DystrophyDystroglycanopathies

    Study Identification, Study Status, Study Description, Conditions, Study Design, Eligibility, Contacts/Locationsv9

  7. Notable

    Primary completion date: Mar 2010 to Mar 2015

    Completion date: Mar 2015 to Mar 2020

    Study Statusv8

  8. Minor

    Site contact updated

    Study Identification, Study Status, Contacts/Locationsv7

  9. Minor

    Study Status

    Re-verified, no change to tracked fields

    v6

  10. Notable

    Lead sponsor: National Institute of Neurological Disorders and Stroke (NINDS) to University of Iowa

    Primary completion date: Mar 2010; Completion date: Mar 2015; Collaborators expanded, about 8 words

    Show what changed: Collaborators
    National Institute of Neurological Disorders and Stroke (NINDS)

    Study Status, Sponsor/Collaborators, Oversight, Study Design, Eligibilityv5

  11. Minor

    3 amendments

    3 re-verifications since 2006-10-13, no change to tracked fields

    v2-v4

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of the study is to describe the early signs and symptoms of the dystroglycanopathies, and to gather information that will be required for future clinical trials.
Trial Details
NCT Number NCT00313677
Lead Sponsor Katherine Mathews
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Muscular Dystrophy
Enrollment 190 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov