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Pilot Study of Minocycline in Huntington's Disease

This study has been completed.
Sponsor:
Collaborator:
FDA Office of Orphan Products Development
Information provided by (Responsible Party):
Merit Cudkowicz, Huntington Study Group
ClinicalTrials.gov Identifier:
NCT00277355
First received: January 12, 2006
Last updated: April 17, 2013
Last verified: April 2013
Results First Received: March 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Condition: Huntington Disease
Interventions: Drug: minocycline
Drug: Matching placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between April 2006 and June 2007 , 134 patients were screened and 114 subjects were randomized at 12 Huntington Study Group clinical sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
20 subjects were excluded from group assignment after screening: 14 failed inclusion criteria and 6 withdrew consent. Minocycline 90 days prior to baseline and open-label during trial not permitted. Other tetracyclines, investigational drugs, lithium, digoxin, methoflurane anesthesia, theophylline and lupus-symptom causing drugs not permitted.

Reporting Groups
  Description
Minocycline 100 mg Twice Daily Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
Matching Placebo Twice Daily Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization).

Participant Flow:   Overall Study
    Minocycline 100 mg Twice Daily   Matching Placebo Twice Daily
STARTED   87   27 
COMPLETED   73   22 
NOT COMPLETED   14   5 
Withdrawal by Subject                3                3 
Lost to Follow-up                2                2 
Adverse Event                5                0 
Death                3                0 
Physician Decision                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Minocycline 100 mg Twice Daily Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
Matching Placebo Twice Daily Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization.
Total Total of all reporting groups

Baseline Measures
   Minocycline 100 mg Twice Daily   Matching Placebo Twice Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 87   27   114 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   85   25   110 
>=65 years   2   2   4 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.1  (10.3)   47.8  (10.6)   47.3  (10.4) 
Gender 
[Units: Participants]
     
Female   46   15   61 
Male   41   12   53 
Region of Enrollment 
[Units: Participants]
     
United States   80   25   105 
Canada   7   2   9 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [LOCF Imputation Method]   [ Time Frame: Baseline to 18 months ]

2.  Secondary:   Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [Regression Based Multiple Imputation Method]   [ Time Frame: Baseline to 18 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Merit Cudkowicz, MD, MSc
Organization: Massachusetts General Hospital
phone: 617-726-1873
e-mail: mcudkowicz@partners.org


Publications:

Responsible Party: Merit Cudkowicz, Huntington Study Group
ClinicalTrials.gov Identifier: NCT00277355     History of Changes
Other Study ID Numbers: FD-R-002588
DOMINO
Study First Received: January 12, 2006
Results First Received: March 7, 2013
Last Updated: April 17, 2013