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Raltegravir (Isentress) Pilot Study in Relapsing Multiple Sclerosis (INSPIRE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01767701
First Posted: January 14, 2013
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Gavin Giovannoni, Queen Mary University of London
Results First Submitted: September 22, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Relapsing Remitting Multiple Sclerosis
Intervention: Drug: Raltegravir

  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
Patients 18-55 years of age with RRMS, as per McDonald Criteria 2010, EDSS up to 6.0, relapse within the past 12 months or at least one active Gd enhanced lesion on brain MRI within the 3 months prior to consent. All participants were recruited at the Clinical Research Centre of the Royal London Hospital and drawn from greater London.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
31 subjects screened. 8 had no evidence of Gd enhancing lesions in their baseline MRI and were screen failed. Of the 23 participants who were recruited into the study 3 were withdrawn prior to starting the treatment phase; one at the request of the participant and the remaining two due to MS relapse.

Reporting Groups
  Description
Raltegravir

All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.

Raltegravir: 400mg twice daily for 3 months


Participant Flow:   Overall Study
    Raltegravir
STARTED   20 [1] 
COMPLETED   20 
NOT COMPLETED   0 
[1] All 20 patients who entered the treatment phase completed the six months trial period.



  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
Raltegravir

All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.

Raltegravir: 400mg twice daily for 3 months


Baseline Measures
   Raltegravir 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      20 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      14  70.0% 
Male      6  30.0% 
Region of Enrollment 
[Units: Participants]
 
United Kingdom   20 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Number of New or Recurrent Gd-enhancing Lesions That Appear on Brain T1-weighted MRI   [ Time Frame: Baseline and at 6 months ]

2.  Secondary:   The Cumulative Number of New or Enlarging T2 Weighted Lesions on Brain MRI.   [ Time Frame: Baseline and monthly for 6 months ]

3.  Secondary:   Change in Score on Multiple Sclerosis Functional Composite (MSFC). This a Composite Score Based on the Measurement of Time in Seconds for the Three Separate Measurements.   [ Time Frame: Baseline and monthly until month 6. ]

4.  Secondary:   Changes in Kurtzke Extended Disability Status Scale (EDSS) Score   [ Time Frame: Baseline and monthly to month 6 ]

5.  Secondary:   Cumulative Number of Gd-T1 Enhancing Lesions   [ Time Frame: At Baseline and monthly for 6 months ]

6.  Secondary:   Percent of Subjects With Scans Free From Enhancing Lesions in Raltegravir Treated Subjects vs. Baseline   [ Time Frame: Baseline to 6 months ]

7.  Other Pre-specified:   Mean Number of Adverse Events Per Patient   [ Time Frame: Screening to six months ]

8.  Other Pre-specified:   Effect of Raltegravir Therapy on Specific Inflammatory Marker of MS Activity.   [ Time Frame: Baseline to 6 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Professor Gavin Giovannoni
Organization: Queen Mary University of London
e-mail: g.giovannoni@qmul.ac.uk


Publications:

Responsible Party: Gavin Giovannoni, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01767701     History of Changes
Other Study ID Numbers: 008717QM
2012-004847-61 ( EudraCT Number )
First Submitted: January 7, 2013
First Posted: January 14, 2013
Results First Submitted: September 22, 2016
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017