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A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients. (Advance)

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ClinicalTrials.gov Identifier: NCT03231878
Recruitment Status : Active, not recruiting
First Posted : July 27, 2017
Last Update Posted : November 1, 2021
Sponsor:
Information provided by (Responsible Party):
Minoryx Therapeutics, S.L.

Tracking Information
First Submitted Date  ICMJE July 24, 2017
First Posted Date  ICMJE July 27, 2017
Last Update Posted Date November 1, 2021
Actual Study Start Date  ICMJE December 8, 2017
Actual Primary Completion Date June 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
To evaluate the efficacy of MIN-102 on the progression of adrenomyeloneuropathy (AMN) in male patients as determined by a motor function test. [ Time Frame: in 96 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 26, 2017)
To evaluate the efficacy of MIN-102 on the progression of adrenomyeloneuropathy (AMN) in male patients as determined by a walking test (motor function). [ Time Frame: in 96 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2020)
  • To evaluate the efficacy of MIN-102 in terms of patient reported outcomes. [ Time Frame: in 96 weeks ]
  • SSPROM (Severity Score System for Progressive Myelopathy ) [ Time Frame: in 96 weeks ]
  • EDSS (Expanded Disability Status Scale ) [ Time Frame: in 96 weeks ]
  • Quality of life scales (Euroqol) [ Time Frame: in 96 weeks ]
  • Incidence of cerebral inflammatory lesions [ Time Frame: in 96 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2017)
  • To evaluate the efficacy of MIN-102 in terms of patient reported outcomes. [ Time Frame: in 96 weeks ]
  • SSPROM (Severity Score System for Progressive Myelopathy ) [ Time Frame: in 96 weeks ]
  • EDSS (Expanded Disability Status Scale ) [ Time Frame: in 96 weeks ]
  • Quality of life scales (Euroqol) [ Time Frame: 96 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients.
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Multinational, Multicenter Study With Open-label Treatment Extension to Assess the Effect of MIN-102 (IMP) on the Progression of Adrenomyeloneuropathy in Male Patients With X-linked Adrenoleukodystrophy
Brief Summary This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter, two parallel-group study in male patients with the AMN phenotype of X-linked adrenoleukodystrophy (X-ALD) to assess the efficacy and safety of MIN-102 treatment. Study sites will consist of specialist referral centers experienced in the management of adrenoleukodystrophy (ALD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Adrenoleukodystrophy
Intervention  ICMJE
  • Drug: MIN-102
    MIN-102 treatment
  • Drug: Placebos
    Placebo
Study Arms  ICMJE
  • Active Comparator: Active
    Intervention: Drug: MIN-102
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebos
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 26, 2017)
105
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Actual Primary Completion Date June 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and between 18-65 years of age.
  • Diagnosed with X-linked adrenoleukodystrophy (X-ALD) based on elevated VLCFA and genetic testing.
  • Clinical evidence of spinal cord involvement.

Exclusion Criteria:

  • Any other chronic neurological disease with signs of spastic paraplegia, such as hereditary spastic paraplegia, multiple sclerosis, etc.
  • Presence of inflammatory (Gd-enhancing) MRI lesions or any abnormality other than those mentioned in the inclusion criteria.
  • Known type 1 or type 2 diabetes.
  • Known intolerance to pioglitazone or any other thiazolidinedione.
  • Taking or have taken honokiol, pioglitazone or other thiazolidinediones within the 6 months prior to screening.
  • Previous bone marrow transplantation.
  • Previous or current history of cancer (other than treated basal cell carcinoma).
  • Previous or current history of congestive heart failure.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 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,   Germany,   Hungary,   Italy,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03231878
Other Study ID Numbers  ICMJE MT-2-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Minoryx Therapeutics, S.L.
Study Sponsor  ICMJE Minoryx Therapeutics, S.L.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Minoryx Therapeutics, S.L.
Verification Date November 2020

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